Search and Filter Protocols

Use the checkboxes and search input field to locate the relevant protocol.

To filter by categories, simply select the relevant categories and/or statuses and click "submit" (without entering any text into the search field).

To search by Protocol name, simply enter it into the search box and click "submit".

  • Disease Categories

*NOTE* if there are categories that have no protocols attached, they will not show up as a checkbox for filtering. For example, if "Head and Neck" is not available as a disease category checkbox selection, there are no protocols that have that disease category assigned.

All Current Protocols Arranged Alphabetically by Disease Category:

Brain

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A071401

Primary Category:

Treatment Protocols

Disease Category:

Brain

Status:

Temporarily Closed

Phase II Trial of SMO / AKT / NF2 Inhibitors in Progressive Meningiomas with SMO / AKT / NF2 Mutations

 

The A071401 NF2 Grade I and NF2 Grade II/III cohorts have met their accrual goals. Therefore, EFFECTIVE 07/19/17, no new patients may register (Step 1) to the NF2 Grade I or Grade II/III cohorts. 

NCT#02523014

Effective immediately on 02/07/18, pre-registration (Step 0) and registration (Step 1) to A071401 have been temporarily suspended. The manufacturer of the investigational agent vismodegib has discontinued provision to new patients on A071401. Therefore, effectively immediately, the SMO/PTCH1 Grade I and SMO/PTCH1 Grade II/III cohorts on A071401 are closed to new patient registration (Step 1).

ALLIANCE A071601

Primary Category:

Treatment Protocols

Disease Category:

Brain

Status:

Open

Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas

 

NCT#03224767

ALLIANCE CCTG CE.7

Primary Category:

Radiation Oncology

Disease Category:

Brain, Brain Metastatic

Status:

Temporarily Closed

A Phase III Trial of Stereotactic Radiosurgery Compared With Whole Brain Radiotherapy (WBRT) for 5-15 Brain Metastases

For CCTG CE.7, please credit ALLIANCE all accruals.

NCT#03550391

Enrollment of new patients to this study has been temporarily suspended effective immediately, 03/08/19, pending protocol amendment. Based on preliminary results of the NRG-CC001 study, presented at the 2018 Annual Meeting of the American Society for Radiation Oncology (ASTRO) and during the plenary session of the 2018 Annual Meeting of the Society for Neuro-Oncology (SNO), an amendment has been submitted to CTEP revising the WBRT control arm of the CE.7 trial to incorporate hippocampal avoidance. Accrual will resume upon approval and activation of the amendment.

ALLIANCE N0577

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Brain

Status:

Open

Phase III Intergroup Study of Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma

Eligible for screening study DCP 001

MCC is a legacy NCCTG institution and site must offer patient participation in N0392 QOL study prior to randomization on N0577.  See N0392 protocol page for separate consent form and additional information.

NCT#00887146

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

NRG BN003

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Brain

Status:

Open

Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma

Eligible for screening study DCP 001

NCT#03180268

NRG CC003

Primary Category:

Radiation Oncology

Disease Category:

Brain, Lung, Lung - Small Cell, Lung - Small Cell Extensive Stage, Lung - Small Cell Limited Stage

Status:

Open

Randomized Phase II/III Trial of Prophylatic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer

NCT#02635009

Eligible for screening study DCP 001

Reactivation to Phase III accrual as of 01/09/19.

SWOG S1614

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT#03887702

Breast

AFT-25 COMET

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Breast, Breast DCIS

Status:

Open

Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial

NCT#02926911

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC a protocol specific Training Log and an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-27 IMPASSION

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer

NCT#03498716

Limited institution study – Only open to:  Billings Clinic

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A011106

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Temporarily Closed

ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study

Eligible for screening study DCP 001

NCT#01953588

Randomization to the fulvestrant arm (Arm 2) and the anastrozole + fulvestrant arm (Arm 3) will be closed to new patient accrual on 11/01/2018; accrual to these two arms has been met per protocol. Beginning on 11/01/2018 all new patients registered to A011106 will be registered to the anastrozole arm (Arm 1).

A011106 is soon expected to reach its accrual goal. Therefore, EFFECTIVE THURSDAY, May 9, 2019 at 4:30 PM ET, A011106 will be temporarily suspended to new patient registration as the study team evaluates the current accrual and study design.

ALLIANCE A011202

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Temporarily Closed

A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

Eligible for screening study DCP 001

The protocol-specified number of patients to be pre-registered has been met. Therefore, Alliance A011202 has been temporarily suspended to new patient pre registration (Step 0) EFFECTIVE IMMEDIATELY, Thursday, April 18, 2019. The protocol will be amended to increase the number of pre-registrations required to meet its registration accrual goal.

NCT#01901094

ALLIANCE A011401

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Adjuvant Breast, Breast, Breast Neoadjuvant

Status:

Open

Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

Eligible for screening study DCP 001

NCT#02750826

The A011401 Health Behaviors and Patient Reported Outcomes substudy HO1 will soon meet its study accrual goal. Therefore,  EFFECTIVE July 06, 2017 at 4:30 pm ET, A011401 substudy HO1 will permanently close to new patient accrual.

ALLIANCE A011502

Primary Category:

Cancer Control and Prevention Protocols, Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

A Randomized Phase III Double-Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial

See Companion Study A211601 

Eligible for screening study DCP 001

NCT#02927249

ALLIANCE A171601

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

New, Open

A Phase II Trial Assessing the Tolerability of Palbociclib in Combination with Letrozole or Fulvestrant in Patients Aged 70 and Older with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer

NCT#03633331

Eligible for screening study DCP 001

ALLIANCE A211601

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

New, Open

Evaluation of Mammographic Breast Density Effect of Aspirin: A Companion to Alliance Study A011502

NCT#03609021

Eligible for screening study DCP 001

ALLIANCE A221405

Primary Category:

Cancer Control and Prevention Protocols, Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE breast cancer

NCT#02308085

Eligible for screening study DCP 001

This protocol has additional regulatory requirements to be completed prior to registering any patients at your site.  Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

ALLIANCE A221505

Primary Category:

Radiation Oncology, Surgical Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction

NCT#03414970

Eligible for screening study DCP 001

ALLIANCE A221701

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal

Status:

New, Open

Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches

NCT#03839940

Eligible for screening study DCP 001

ALLIANCE A231701CD

Primary Category:

Cancer Care Delivery, Surgical Protocols

Disease Category:

Breast, Cancer Care Delivery

Status:

New, Open

Increasing Socioeconomically Disadvantaged Patients’ Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention

NCT#03766009

Limited institution study – Only open to:  Billings Clinic

ECOG-ACRIN EA1131

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoadjuvant Chemotherapy

Eligible for screening study DCP 001

NCT#02445391

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

NRG B-51

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Open

Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

Eligible for screening study DCP 001

NCT#01872975

The accrual goal for the Behaviorial and Health Outcomes (BAHO) Quality of Life component in the B-51 trial has been met. Therefore, effective August 6th, 2018, accrual will be closed to the QoL component. The B-51 trial remains open to accrual.

NRG BR002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

NCT#02364557

NRG BR003

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

Eligible for screening study DCP 001

NCT#02488967

NRG BR004

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

New, Open

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

NCT#03199885

NRG BR005

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Temporarily Closed

A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients with Clinical/Radiologic Complete Response after Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment without Surgery

NCT#03188393

Effective immediately, May 17th, 2019, NRG-BR005 is temporarily closed to enrollment of new patients until Amendment 1 has been reviewed and approved.

NRG CC004

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gynecologic

Status:

Open

Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer

Eligible for screening study DCP 001

NCT#03180294

This protocol has additional regulatory requirements to be completed prior to registering any patients at your site.  Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

NRG CCTG MA.39

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

New, Open

A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

For CCTG MA.39, please credit NRG all accruals.

NCT#03550391

SWOG S1416

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

Phase II Randomized Placebo-Controlled Trial of Cisplatin with or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer

NCT#02595905

S1416 has an accrual goal of 235 in the main cohort and 98 in the brain metastases cohort for a total of 333 patients. The main cohort was reactivated on July 18, 2018. The brain metastases cohort will remain open. The overall accrual target for S1416 has not changed.

Effective June 15th, 2019, SWOG S1416, will be permanently closed to accrual.

SWOG S1418

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

Eligible for screening study DCP 001

NCT#02954874

Site Delegation of Tasks Log required prior to registration of any patients.

SWOG S1501

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III

Eligible for screening study DCP 001

NCT#03418961

SWOG S1614

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT#03887702

SWOG S1703

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer

NCT#03723928

Eligible for screening study DCP 001

SWOG S1706

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

New, Open

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer

NCT#03598257

Cancer Care Delivery

ALLIANCE A231701CD

Primary Category:

Cancer Care Delivery, Surgical Protocols

Disease Category:

Breast, Cancer Care Delivery

Status:

New, Open

Increasing Socioeconomically Disadvantaged Patients’ Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention

NCT#03766009

Limited institution study – Only open to:  Billings Clinic

ECOG-ACRIN EAQ162CD

Primary Category:

Cancer Care Delivery, Cancer Control and Prevention Protocols

Disease Category:

Cancer Care Delivery, Colon, Gastrointestinal, Rectal

Status:

Open

Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer Treated with Curative Intent

NCT#03516942

Eligible for screening study DCP 001

Accrual to the “Colon Cancer, Receiving Chemotherapy” (or Colon/Chemo) cohort will be closed to accrual and the “Rectal Cancer, Receiving Chemotherapy” (or Rectal/Chemo) cohort will be suspended to accrual on May 2, 2019, as they are nearing their study-specified accrual thresholds.

ECOG-ACRIN EAQ171CD

Primary Category:

Cancer Care Delivery

Disease Category:

Cancer Care Delivery

Status:

New, Open

Implementing a Virtual Tobacco Treatment in Community Oncology Practices: “Smoke Free Support Study 2.0”

NCT#03808818

Contact Amanda Dinsdale at 406-969-6063 or adinsdale@mtcancer.org if your site is interested in participating in this study.

SWOG S1415CD

Primary Category:

Cancer Care Delivery, Cancer Control and Prevention Protocols

Disease Category:

Cancer Care Delivery

Status:

Open

A Pragmatic Trial Evaluating a Colony Stimulating Factor Intervention in Standing Orders and the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia

 

Limited site participation.  Open only to Billings Clinic, Bozeman Health, and Saint Alphonsus

NCT#02728596

Eligible for screening study DCP 001

WAKE WF-1803CD

Primary Category:

Cancer Care Delivery

Disease Category:

Cancer Care Delivery

Status:

New, Open

Supportive Care Service Availability for Cancer Caregivers in Community Oncology Practices

NCT#03746314

Contact Amanda Dinsdale at 406-969-6063 or adinsdale@mtcancer.org if your site is interested in participating in this study.

Gastrointestinal

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A021502

Primary Category:

Treatment Protocols

Disease Category:

Colon, Gastrointestinal

Status:

Open

Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair

Eligible for screening study DCP 001

NCT#02912559

Site Delegation of Tasks Log required prior to registration of any patients.

ALLIANCE A021602

Primary Category:

Treatment Protocols

Disease Category:

Carcinoid, Neuroendocrine, Pancreatic

Status:

Open

Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)

NCT#03375320

Eligible for screening study DCP 001

ALLIANCE A221701

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal

Status:

New, Open

Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches

NCT#03839940

Eligible for screening study DCP 001

ECOG-ACRIN EA2142

Primary Category:

Treatment Protocols

Disease Category:

Gastrointestinal, Neuroendocrine

Status:

Open

Randomized Phase II Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas

NCT#02595424

ECOG-ACRIN EA2161

Primary Category:

Treatment Protocols

Disease Category:

Carcinoid, Gastrointestinal, Neuroendocrine, Pancreatic

Status:

Temporarily Closed

A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)

Due to completion of accrual to the first stage, accrual to EA2161 is temporarily suspended effective 11/5/18.  Only patients who have signed a consent to participate on or before 3:00 PM MST November 5, 2018 will be accepted. Consented patients must be registered on or before 3:00 PM MST November 12, 2018.

NCT#02893930

ECOG-ACRIN EA2165

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Anal, Gastrointestinal

Status:

Open

A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer

NCT#03233711

ECOG-ACRIN EAQ162CD

Primary Category:

Cancer Care Delivery, Cancer Control and Prevention Protocols

Disease Category:

Cancer Care Delivery, Colon, Gastrointestinal, Rectal

Status:

Open

Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer Treated with Curative Intent

NCT#03516942

Eligible for screening study DCP 001

Accrual to the “Colon Cancer, Receiving Chemotherapy” (or Colon/Chemo) cohort will be closed to accrual and the “Rectal Cancer, Receiving Chemotherapy” (or Rectal/Chemo) cohort will be suspended to accrual on May 2, 2019, as they are nearing their study-specified accrual thresholds.

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

NRG GI002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Gastrointestinal, Rectal

Status:

Temporarily Closed

A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer

NCT#02921256

As of February 12, 2018 Arm 2 is permanently closed having met its enrollment goal.

The NRG-GI002 study serves as a platform to test novel agents in the neoadjuvant treatment of rectal cancer. It is projected that enrollment to the ARM1 (control) vs. ARM 3 (MK-3475/pembrolizumab) comparison could meet the accrual goal of 178 patients as early as May 13, 2019. The pembrolizumab comparison will complete enrollment before activation of another experimental arm. This will result in a temporary suspension of accrual to the entire NRG-GI002 trial.

As of Tuesday, May 14th, 2019 at 9:00 am EST, NRG-GI002 has met its accrual goal and is temporarily suspended.

NRG GI004

Primary Category:

Treatment Protocols

Disease Category:

Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic

Status:

Open

Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer

Eligible for screening study DCP 001

NCT#02997228

Site Delegation of Tasks Log required prior to registration of any patients.

SWOG S1613

Primary Category:

Treatment Protocols

Disease Category:

Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic

Status:

Temporarily Closed

A Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (MCRC) with HER-2 Amplification

 

NCT#03365882

Effective immediately, May 17th, 2019, S1613 Step 1, is temporarily closed to accrual of new patients to accommodate the relocation of the screening laboratory. Patients may continue to be registered to Step 2.

SWOG S1614

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT#03887702

SWOG S1815

Primary Category:

Treatment Protocols

Disease Category:

Cholangiocarcinoma, Gallbladder, Gastrointestinal

Status:

New, Open

A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

NCT#03768414

Genitourinary

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A031102

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary

Status:

Open

A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

Eligible for screening study DCP 001

NCT#02375204

ALLIANCE A031501

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

New, Open

Phase III Randomized Adjuvant study of MK-3475 (Pembrolizumab) in muScle invaSive and locAlly aDvanced urOthelial caRcinoma (AMBASSADOR) Versus Observation

NCT#03244384

Eligible for screening study DCP 001

ALLIANCE A031701

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

New, Temporarily Closed

A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (ddGC) in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

NCT#03609216

Due to laboratory requirements necessitating the collection of additional information for genomic testing from all participating patients, A031701 is temporarily suspended, effective immediately, 04/11/19. An updated protocol and informed consent will be forthcoming.

ALLIANCE A031702

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary, Prostate, Renal

Status:

New, Open

Phase II Study of Cabozantinib in Combination with Nivolumab and Ipilimumab in Rare Genitourinary Tumors

NCT#03866382

 

ALLIANCE A031704

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Renal, Renal Metastatic

Status:

New, Open

PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]

Eligible for screening study DCP 001

NCT#03793166

ALLIANCE A221701

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal

Status:

New, Open

Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches

NCT#03839940

Eligible for screening study DCP 001

ECOG-ACRIN EA8143

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Renal

Status:

Open

A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Eligible for screening study DCP 001

NCT#03055013

Site Delegation of Tasks Log required prior to registration of any patients.

ECOG-ACRIN EA8153

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Prostate, Prostate Metastatic

Status:

Open

Cabazitaxel with Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial

NCT#03419234

ECOG-ACRIN EA8171

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

Open

Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer

NCT#03697148

EA8171 will reactivate on 10/15/18 with the implementation of Addendum 1.

EA8171 is temporarily suspended, effective immediately, 07/13/18.  It will reopen to accrual once administrative updates are processed.

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

NRG GU002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

Open

Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel

 

NCT#03070886

NRG GU005

Primary Category:

Radiation Oncology

Disease Category:

Genitourinary, Prostate

Status:

Open

Phase III IGRT and SBRT Vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer

Eligible for screening study DCP 001

NCT#03367702

*RT Credentialing Required

**Because the AJCC staging version 8 was not ready for the study activation, AJCC staging version 7 must be used.

NRG GU006

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate, Prostate Recurrent

Status:

Open

A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy with or Without Enhanced Anti-Androgen Therapy with Apalutamide in Recurrent Prostate Cancer

NCT#03371719

NRG R0924

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

Open

Androgen Deprivation Therapy and High Dose Radiotherapy with or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial

 

(QOL Sub-study is closed as its accrual goal has been met.)

Eligible for screening study DCP 001

NCT#01368588

SWOG S1500

Primary Category:

Treatment Protocols

Disease Category:

Renal, Renal Metastatic

Status:

Open

A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)

 

NCT#02761057

Partial permanent closure for Arm 3 and Arm 4 effective 12/05/18.

SWOG S1602

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

Open

A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer

NCT#03091660

Eligible for screening study DCP 001

SWOG S1605

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

Open

Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

 

NCT#02844816

SWOG S1614

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT#03887702

SWOG S1802

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Genitourinary, Prostate, Prostate Metastatic

Status:

New, Open

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

NCT#03678025

Eligible for screening study DCP 001

SWOG S1806

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

New, Open

Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer

NCT#03775265

 

Gynecologic

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

GOG Foundation GOG 3018/VB-111-701

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian

Status:

New, Open

The OVAL Study: A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined with Paclitaxel vs. Paclitaxel Combined with Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer

NCT#03398655

GOG Foundation GOG-3024/GCT1015-05

Primary Category:

Treatment Protocols

Disease Category:

Cervical, Cervical Metastatic, Gynecologic

Status:

New, Open

A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax-TF-ADC) in Combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical Cancer

NCT#03786081

NRG CC004

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gynecologic

Status:

Open

Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer

Eligible for screening study DCP 001

NCT#03180294

This protocol has additional regulatory requirements to be completed prior to registering any patients at your site.  Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

NRG G0237

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

GYN Other

Status:

Open

Comparative Analysis of CA-IX, p16, Proliferative Markers, and Human Papilloma Virus (HPV) in the Diagnosis of Significant Cervical Lesions in Patients with a Cytologic Diagnosis of Atypical Glandular Cells (AGC)

NCT#00892866

Eligible for screening study DCP 001

 

NRG G0263

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Cervical, Gynecologic

Status:

Open

Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy

Eligible for screening study DCP 001

NCT#01101451

NRG GY005

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian

Status:

Open

A Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)

NCT#02502266

Reactivated to accrual on Phase III with Amendment #7, 01/02/19.

This protocol has additional regulatory requirements to be completed prior to registering any patients at your site.  Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

NRG GY006

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Cervical, Gynecologic

Status:

Open

A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

NCT#02466971

NRG GY007

Primary Category:

Surgical Protocols, Treatment Protocols

Disease Category:

Gynecologic, Ovarian, Ovarian Metastatic

Status:

New, Open

A Phase I/II Study of Ruxolitinib with Front-Line Neoadjuvant and Post-Surgical Therapy in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

NCT#02713386

Study open to Phase II accrual.

This protocol has additional regulatory requirements to be completed prior to registering any patients at your site.  Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

 

 

NRG GY009

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian, Ovarian Metastatic

Status:

Temporarily Closed

A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer

NCT#02839707

NRG-GY009 has met its Phase II accrual goal and is temporarily closed effective May 9th, 2019.

NRG GY012

Primary Category:

Treatment Protocols

Disease Category:

Endometrial, Endometrial Metastatic, Gynecologic

Status:

New, Open

A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer

NCT#03660826

NRG GY014

Primary Category:

Treatment Protocols

Disease Category:

Endometrial, Gynecologic, Ovarian

Status:

New, Open

A Phase II Study of Tazemetostat (EPZ-6438) (IND # 138671) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma

NCT#03348631

NRG GY016

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian

Status:

New, Temporarily Closed

A Phase II Study of MK-3475 (Pembrolizumab) (NSC #776864) + Epacadostat (NSC #766086) in Recurrent Clear Cell Carcinoma of the Ovary

NCT#03602586

Effective immediately on 04/10/19, NRG-GY016 has been temporarily closed to accrual because the study has reached its maximum accrual number of 14 patients for the first stage of the trial.  Accrual will be stopped until data is matured and the analysis on the first stage is complete.

NRG R0724

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Cervical, Gynecologic

Status:

Open

Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy

Eligible for screening study DCP 001

NCT#00980954

SWOG S1614

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT#03887702

Head and Neck

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ECOG-ACRIN EA3132

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Head and Neck

Status:

Open

Phase II Randomized Trial of Adjuvant Radiotherapy with or Without Cisplatin for p53 Mutated, Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)

 

NCT#02734537

ECOG-ACRIN EA3163

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Head and Neck

Status:

Open

Phase II randomized trial of neo-adjuvant chemotherapy followed by surgery and post-operative radiation versus surgery and post-operative radiation for organ preservation of T3 and T4a nasal and paranasal sinus squamous cell carcinoma (NPNSCC)

NCT#03493425

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

NRG HN004

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Head and Neck

Status:

Open

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) Vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin

NCT#03258554

HN004 is temporarily closed to accrual effective immediately, 06/13/18, because the first dose level of the lead-in cohort has enrolled 10 patients. The trial will be closed for approximately 3 months for toxicity assessment.

Site Delegation of Tasks Log required prior to registration of any patients.

SWOG S1614

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT#03887702

Leukemia

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

ALLIANCE A041501

Primary Category:

Treatment Protocols

Disease Category:

Acute Lymphocytic Leukemia, Leukemia

Status:

Open

A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL

NCT#03150693

Eligible for screening study DCP 001

ALLIANCE A041701

Primary Category:

Treatment Protocols

Disease Category:

Acute Myeloid Leukemia, Leukemia

Status:

New, Open

A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults with Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

NCT#03701308

ALLIANCE A041702

Primary Category:

Treatment Protocols

Disease Category:

Chronic Lymphocytic Leukemia, Leukemia

Status:

New, Open

A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (>/= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

NCT#03737981

Eligible for screening study DCP 001

ECOG-ACRIN E1910

Primary Category:

Treatment Protocols

Disease Category:

Acute Lymphocytic Leukemia, Leukemia

Status:

Open

A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults

Eligible for screening study DCP 001

NCT#02003222

ECOG-ACRIN EA9161

Primary Category:

Treatment Protocols

Disease Category:

Chronic Lymphocytic Leukemia, Leukemia

Status:

New, Open

A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)

NCT#03701282

Eligible for screening study DCP 001

ECOG-ACRIN EA9171

Primary Category:

Treatment Protocols

Disease Category:

Chronic Myeloid Leukemia, Leukemia

Status:

New, Open

Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients with Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease

NCT#03516279

ECOG-ACRIN NHLBI-MDS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Leukemia, Myelodysplastic Syndrome

Status:

Open

The National Myelodysplastic Syndromes (MDS) Study

 

NCT#02775383

Eligible for screening study DCP 001

This protocol has additional regulatory requirements to be completed prior to registering any patients at your site.  Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

SWOG S1612

Primary Category:

Treatment Protocols

Disease Category:

Acute Myeloid Leukemia, Leukemia, Myelodysplastic Syndrome

Status:

Temporarily Closed

A Randomized Phase II/III Trial of “Novel Therapeutics” versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older

NCT#03092674

Effective immediately,10/25/18, and until further notice, patients will no longer receive nivolumab as part of this study. Additional details are provided in the Investigator Letter and Patient Information Letter.

Effective immediately, 10/22/18, S1612 will be temporarily closed to accrual based on additional review of the safety data. An “Investigator Letter” and “Patient Notification Letter” will be provided in the coming days, pending regulatory approvals.

SWOG S1712

Primary Category:

Treatment Protocols

Disease Category:

Chronic Myeloid Leukemia, Leukemia

Status:

New, Open

A Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination with BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) Patients with Molecular Evidence of Disease

NCT#03654768

Lung

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A081105

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

(See required screening study ALLIANCE A151216)

Eligible for screening study DCP 001

NCT#02193282

ALLIANCE A151216

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
A screening trial for A081105E4512, and EA5142.

Eligible for screening study DCP 001

NCT#02194738

ALLIANCE A211401

Primary Category:

Cancer Control and Prevention Protocols, Surgical Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Small Cell

Status:

Open

Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes

 

NCT#02856581

ALLIANCE A221504

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

Open

A Randomized, Double-Blind, Placebo-Controlled Pilot Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer (Adenocarcinoma)

NCT#03087708

Eligible for screening study DCP 001

ALLIANCE C30610

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Lung, Lung - Small Cell, Lung - Small Cell Limited Stage

Status:

Open

Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide

Eligible for screening study DCP 001

NCT#00632853

The QOL Substudy C70702 (embedded in C30610) will soon meet its study accrual goal. Therefore,  EFFECTIVE August 30, 2017 at 4:30 pm ET, C70702 will permanently close to new patient accrual.

ECOG-ACRIN E4512

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

(See required screening study ALLIANCE A151216)

Eligible for screening study DCP 001

NCT#02201992

ECOG-ACRIN EA5142

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers

(See required screening study ALLIANCE A151216)

Eligible for screening study DCP 001

NCT#02595944

This protocol has additional regulatory requirements to be completed prior to registering any patients at your site.  Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

 

ECOG-ACRIN EA5152

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

Temporarily Closed

A Randomized Phase II Trial of Nivolumab, Cabozantinib Plus Nivolumab, and Cabozantinib Plus Nivolumab Plus Ipilimumab in Patients with Previously Treated Non-Squamous NSCLC

NCT#03468985

Effective August 8th, 2018,  EA5152 is temporarily suspended to accrual while a redesign of the study is being developed for chemo/immunotherapy refractory patients.

ECOG-ACRIN EA5162

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

Open

Phase II Study of AZD9291 (Osimertinib) in Advanced NSCLC Patients with Exon 20 Insertion Mutations in EGFR

NCT#03191149

ECOG-ACRIN EA5163

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

New, Open

EA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-Driven Analysis

NCT#03793179

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

NRG CC003

Primary Category:

Radiation Oncology

Disease Category:

Brain, Lung, Lung - Small Cell, Lung - Small Cell Extensive Stage, Lung - Small Cell Limited Stage

Status:

Open

Randomized Phase II/III Trial of Prophylatic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer

NCT#02635009

Eligible for screening study DCP 001

Reactivation to Phase III accrual as of 01/09/19.

NRG LU002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

Open

Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial

 

NCT#03137771

NRG LU003

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

New, Open

A Biomarker-Driven Protocol for Previously Treated ALK-Positive Non-Squamous NSCLC Patients: The NCI-NRG ALK Master Protocol

NCT#03737994

Treatment consent forms for individual agents for this study are available upon request when a patient at your site is assigned to a study agent.  Please contact Jodi Fischer, jfischer@mtcancer.org or 406-969-6068, for the consents & for any questions.

NRG LU004

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell

Status:

New, Open

Phase I Trial of Accelerated or Conventionally Fractionated Radiotherapy Combined with MEDI4736 (Durvalumab) in PD-L1 High Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (ARCHON-1)

NCT#03801902

SWOG LUNGMAP

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

New, Open

A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)

NCT#0381445

Eligible for screening study DCP 001

SWOG S1400F

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Temporarily Closed

A Phase II Study of MEDI4736 (Durvalumab) plus Tremelimumab as Therapy for Patients with Previously Treated ANTIPD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)

See Screening Protocol LUNGMAP

NCT#03373760

Effective February 22, 2019 at 2:00 pm Pacific Time, Cohort 1, the acquired resistance cohort of substudy S1400F will be temporarily closed to accrual in order to allow data to mature to conduct the planned interim analysis.  Please note that Cohort 2, the primary resistance cohort, remains open to accrual.

Effective May 15, 2019 at 2:00 pm Pacific Time, Cohort 2, the primary resistance of cohort of substudy S1400F will be temporarily closed to accrual in order to allow data to mature to conduct the planned interim analysis.

SWOG S1614

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT#03887702

SWOG S1619

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Lung, Mesothelioma

Status:

Open

A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed with Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma

 

NCT#03228537

Eligible for screening study DCP 001

SWOG S1800A

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

New, Upcoming - Pending IRB Review

A Phase II Randomized Study of Ramucirumab Plus MK3475 (Pembrolizumab) Versus Standard of Care for Patients Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

NCT#03845296

SWOG S1900A

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

New, Open

A Phase II Study of Rucaparib in Patients with Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)

NCT#03845296

See Screening Protocol LUNGMAP

Lymphoma

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A021602

Primary Category:

Treatment Protocols

Disease Category:

Carcinoid, Neuroendocrine, Pancreatic

Status:

Open

Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)

NCT#03375320

Eligible for screening study DCP 001

ALLIANCE A051301

Primary Category:

Treatment Protocols

Disease Category:

Diffuse Large B-cell Lymphoma, Lymphoma, Non-Hodgkin Lymphoma

Status:

Temporarily Closed

A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma of the Activated B-cell Subtype

Eligible for screening study DCP 001

NCT#02443077

EFFECTIVE IMMEDIATELY, Friday, August 24, 2018, A051301 will be temporarily
suspended to new patient pre-registration (Step 0). Eligible patients who are currently
pre-registered may proceed to registration (Step 1).

Site Delegation of Tasks Log required prior to registration of any patients.

ECOG-ACRIN E4412

Primary Category:

Treatment Protocols

Disease Category:

Hodgkin Lymphoma, Lymphoma

Status:

New, Open

A Phase I Study with an Expansion Cohort/Randomized Phase II Study of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma

NCT#01896999

Open to Phase II accrual.

ECOG-ACRIN EA2161

Primary Category:

Treatment Protocols

Disease Category:

Carcinoid, Gastrointestinal, Neuroendocrine, Pancreatic

Status:

Temporarily Closed

A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)

Due to completion of accrual to the first stage, accrual to EA2161 is temporarily suspended effective 11/5/18.  Only patients who have signed a consent to participate on or before 3:00 PM MST November 5, 2018 will be accepted. Consented patients must be registered on or before 3:00 PM MST November 12, 2018.

NCT#02893930

ECOG-ACRIN EA4151

Primary Category:

Treatment Protocols

Disease Category:

Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin Lymphoma

Status:

Open

A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma in Minimal Residual Disease-Negative First Complete Remission

NCT#03267433

Eligible for screening study DCP 001

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

SWOG S1608

Primary Category:

Treatment Protocols

Disease Category:

Follicular Lymphoma, Lymphoma, Non-Hodgkin Lymphoma

Status:

Open

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

 

NCT#03269669

Molecular Profiling

ALLIANCE A081105

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

(See required screening study ALLIANCE A151216)

Eligible for screening study DCP 001

NCT#02193282

ALLIANCE A151216

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
A screening trial for A081105E4512, and EA5142.

Eligible for screening study DCP 001

NCT#02194738

ECOG-ACRIN E4512

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

(See required screening study ALLIANCE A151216)

Eligible for screening study DCP 001

NCT#02201992

ECOG-ACRIN EA5142

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers

(See required screening study ALLIANCE A151216)

Eligible for screening study DCP 001

NCT#02595944

This protocol has additional regulatory requirements to be completed prior to registering any patients at your site.  Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

 

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

ECOG-ACRIN EAY131-A

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol A: Phase II Trial of Afatinib in Patients with Solid Tumors (Other Than Small Cell and Non-Small Cell Lung Cancer) or Lymphomas, That Have Activating Mutations of EGFR and Have Progressed After Standard Treatment

(See required screening study ECOG-ACRIN EAY131)

Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

NCT#02465060

Protocol

ECOG-ACRIN EAY131-C1

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Temporarily Closed

MATCH Treatment Subprotocol C1: Crizotinib in Patients with Tumors with MET Amplification

(See required screening study ECOG-ACRIN EAY131)

Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Due to the completion of accrual, all new assignments to this treatment arm will be suspended effective immediately, 06/19/18, until further notice.

NCT#02465060

ECOG-ACRIN EAY131-C2

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol C2: Crizotinib in Patients with Tumors with MET Exon 14 Deletion

(See required screening study ECOG-ACRIN EAY131)

Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

NCT#02465060

ECOG-ACRIN EAY131-E

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol E: AZD9291 in Patients with Tumors Having EGFR T790M Mutations (Except Non-Small Cell Lung Cancer) or Rare Activating Mutations of EGFR

(See required screening study ECOG-ACRIN EAY131)

Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

NCT#02465060

ECOG-ACRIN EAY131-K2

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol K2: Phase 2 Study of Erdafitinib (JNJ-42756493) in Patients with Tumors with FGFR Mutations and Fusions

(See required screening study ECOG-ACRIN EAY131)

Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

NCT#02465060

ECOG-ACRIN EAY131-L

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol L: Phase II Study of MLN0128 (TAK-228) in Patients with Tumors with mTOR Mutations

(See required screening study ECOG-ACRIN EAY131)

Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

NCT#02465060

ECOG-ACRIN EAY131-M

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Temporarily Closed

MATCH Treatment Subprotocol M: Phase II Study of MLN0128 (TAK-228) in Patients with Tumors with TSC1 or TSC2 Mutations

(See required screening study ECOG-ACRIN EAY131)

Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Effective immediately, May 20th, 2019, EAY131 Subprotocol M, is suspended due to the completion of accrual.  *Patients who are currently being treated on Subprotocol M will continue on the study with no changes in the participation according to the Master Protocol and Subprotocol.

NCT#02465060

ECOG-ACRIN EAY131-T

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol T: GDC-0449 (vismodegib) in Patients with Tumors (except basal cell skin carcinoma) with Smoothened (SMO) or Patched 1 (PTCH1) Mutations

(See required screening study ECOG-ACRIN EAY131)

Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

NCT#02465060

ECOG-ACRIN EAY131-V

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol V: Phase II Study of Sunitinib in Patients with Tumors with cKIT Mutations (Excluding GIST, Renal Cell Carcinoma or Pancreatic Neuroendocrine Tumor)

(See required screening study ECOG-ACRIN EAY131)

Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

NCT#02465060

ECOG-ACRIN EAY131-Z1C

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Temporarily Closed

MATCH Treatment Subprotocol Z1C: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CDK4 or CDK6 Amplification and Rb Protein Expression by IHC

(See required screening study ECOG-ACRIN EAY131)

EAY131 (MATCH) Subprotocol Z1C is suspended effective 10/18/18.

EAY131 (MATCH) Subprotocol Z1C  is nearing the completion of its accrual goal, and only a limited number of available treatment assignment slots remain. 09/21/18

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

NCT#02465060

ECOG-ACRIN EAY131-Z1E

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol Z1E: LOXO-101 in Patients with Tumors with NTRK Fusions

(See required screening study ECOG-ACRIN EAY131)

Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

NCT#02465060

ECOG-ACRIN EAY131-Z1G

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol Z1G: Phase 2 STudy of Copanlisib in Patients with Tumors with PTEN Loss by IHC and Any PTEN Sequencing Result

(See required screening study ECOG-ACRIN EAY131)

Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

NCT#02465060

ECOG-ACRIN EAY131-Z1H

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol Z1H: Phase 2 STudy of Copanlisib in Patients with Tumors with Deleterious PTEN Sequencing Result and PTEN Expression by IHC

(See required screening study ECOG-ACRIN EAY131)

Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

NCT#02465060

SWOG S1400F

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Temporarily Closed

A Phase II Study of MEDI4736 (Durvalumab) plus Tremelimumab as Therapy for Patients with Previously Treated ANTIPD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)

See Screening Protocol LUNGMAP

NCT#03373760

Effective February 22, 2019 at 2:00 pm Pacific Time, Cohort 1, the acquired resistance cohort of substudy S1400F will be temporarily closed to accrual in order to allow data to mature to conduct the planned interim analysis.  Please note that Cohort 2, the primary resistance cohort, remains open to accrual.

Effective May 15, 2019 at 2:00 pm Pacific Time, Cohort 2, the primary resistance of cohort of substudy S1400F will be temporarily closed to accrual in order to allow data to mature to conduct the planned interim analysis.

SWOG S1609

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

NCT#02834013

Eligible for screening study DCP 001

Please see http://www.swogstat.org/accrual/dart.htm for up-to-date accrual information and current cohort accrual status (i.e. open, closed, suspended).  The website is updated with the most current information daily.

Multiple Myeloma

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A171601

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

New, Open

A Phase II Trial Assessing the Tolerability of Palbociclib in Combination with Letrozole or Fulvestrant in Patients Aged 70 and Older with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer

NCT#03633331

Eligible for screening study DCP 001

NRG BR002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

NCT#02364557

NRG BR004

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

New, Open

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

NCT#03199885

SWOG S1416

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

Phase II Randomized Placebo-Controlled Trial of Cisplatin with or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer

NCT#02595905

S1416 has an accrual goal of 235 in the main cohort and 98 in the brain metastases cohort for a total of 333 patients. The main cohort was reactivated on July 18, 2018. The brain metastases cohort will remain open. The overall accrual target for S1416 has not changed.

Effective June 15th, 2019, SWOG S1416, will be permanently closed to accrual.

SWOG S1501

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III

Eligible for screening study DCP 001

NCT#03418961

SWOG S1703

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer

NCT#03723928

Eligible for screening study DCP 001

Neuroendocrine

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A021602

Primary Category:

Treatment Protocols

Disease Category:

Carcinoid, Neuroendocrine, Pancreatic

Status:

Open

Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)

NCT#03375320

Eligible for screening study DCP 001

ALLIANCE A221701

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal

Status:

New, Open

Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches

NCT#03839940

Eligible for screening study DCP 001

ECOG-ACRIN EA2142

Primary Category:

Treatment Protocols

Disease Category:

Gastrointestinal, Neuroendocrine

Status:

Open

Randomized Phase II Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas

NCT#02595424

ECOG-ACRIN EA2161

Primary Category:

Treatment Protocols

Disease Category:

Carcinoid, Gastrointestinal, Neuroendocrine, Pancreatic

Status:

Temporarily Closed

A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)

Due to completion of accrual to the first stage, accrual to EA2161 is temporarily suspended effective 11/5/18.  Only patients who have signed a consent to participate on or before 3:00 PM MST November 5, 2018 will be accepted. Consented patients must be registered on or before 3:00 PM MST November 12, 2018.

NCT#02893930

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

SWOG S1614

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT#03887702

Other

ALLIANCE A011106

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Temporarily Closed

ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study

Eligible for screening study DCP 001

NCT#01953588

Randomization to the fulvestrant arm (Arm 2) and the anastrozole + fulvestrant arm (Arm 3) will be closed to new patient accrual on 11/01/2018; accrual to these two arms has been met per protocol. Beginning on 11/01/2018 all new patients registered to A011106 will be registered to the anastrozole arm (Arm 1).

A011106 is soon expected to reach its accrual goal. Therefore, EFFECTIVE THURSDAY, May 9, 2019 at 4:30 PM ET, A011106 will be temporarily suspended to new patient registration as the study team evaluates the current accrual and study design.

ALLIANCE A011401

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Adjuvant Breast, Breast, Breast Neoadjuvant

Status:

Open

Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

Eligible for screening study DCP 001

NCT#02750826

The A011401 Health Behaviors and Patient Reported Outcomes substudy HO1 will soon meet its study accrual goal. Therefore,  EFFECTIVE July 06, 2017 at 4:30 pm ET, A011401 substudy HO1 will permanently close to new patient accrual.

ALLIANCE A221602

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Other

Status:

Open

Olanzapine With or Without Fosaprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Phase III Randomized, Double Blind, Placebo-Controlled Trial

NCT#03578081

Eligible for screening study DCP 001

DCP 001

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Other

Status:

Open

Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

 

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

NRG B-51

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Open

Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

Eligible for screening study DCP 001

NCT#01872975

The accrual goal for the Behaviorial and Health Outcomes (BAHO) Quality of Life component in the B-51 trial has been met. Therefore, effective August 6th, 2018, accrual will be closed to the QoL component. The B-51 trial remains open to accrual.

NRG BR005

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Temporarily Closed

A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients with Clinical/Radiologic Complete Response after Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment without Surgery

NCT#03188393

Effective immediately, May 17th, 2019, NRG-BR005 is temporarily closed to enrollment of new patients until Amendment 1 has been reviewed and approved.

SWOG S1614

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT#03887702

SWOG S1701

Primary Category:

Treatment Protocols

Disease Category:

Other

Status:

New, Open

A Randomized Phase II Trial of Carboplatin-Paclitaxel with or Without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma

NCT#03694002

SWOG S1702

Primary Category:

Treatment Protocols

Disease Category:

Other

Status:

Open

A Phase II Study of Isatuximab (SAR650984) for Patients with Previously Treated AL Amyloidosis

NCT#03499808

Sarcoma

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A091401

Primary Category:

Treatment Protocols

Disease Category:

Sarcoma

Status:

Temporarily Closed

Randomized Phase II Study of Nivolumab with or Without Ipilimumab in Patients with Metastatic or Unresectable Sarcoma

NCT#02500797

Alliance A091401 has pre-registered a sufficient number of patients in all cohorts to meet its enrollment goal. Therefore, EFFECTIVE IMMEDIATELY, Wednesday, September 5, 2018, A091401 will be temporarily suspended to enrollment until further notice. Patients who are currently pre-registered can proceed to registration, if eligible.

As of Update #06, patient enrollment will be facilitated using the Slot Reservation System.  Prior to discussing protocol entry with the patient, all site staff must contact MCC to ensure that a slot on the correct cohort is available to the patient. Once a slot reservation confirmation is obtained, site staff may then proceed to consent and pre-register the patient. Once a patient is pre-registered, specimens should be submitted for central pathology review. There will be no renewal of slots for this protocol. Therefore, pre registration must be completed within 7 calendar days of slot reservation.

As of 05/31/18 the GIST cohort has no remaining slots for patient registrations.

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

NRG DT001

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Sarcoma

Status:

New, Open

A Phase Ib Trial of Neoadjuvant AMG-232 Concurrent with Preoperative Radiotherapy in Wild-Type P53 Soft Tissue Sarcoma (STS)

NCT#03217266

Cohort A is temporarily closed to accrual effective immediately because 3 patients have been enrolled, which is the maximum allowed per protocol. The cohort A of this trial will be temporarily closed for at least 9 weeks until all 3 patients complete the DLT evaluation period.

SWOG S1614

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT#03887702

Skin

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

Limited institution study – Only open to:  Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.

Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A091605

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Skin

Status:

Open

A Randomized Phase II Study of Anti-PD1 Antibody [MK-3475 (Pembrolizumab)] Alone Versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy in Advanced Merkel Cell Carcinoma

NCT#03304639

ALLIANCE A091802

Primary Category:

Treatment Protocols

Disease Category:

Skin

Status:

New, Open

Phase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)

NCT#03944941

ECOG-ACRIN EA6134

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma, Skin

Status:

Open

A Randomized Phase III trial of Dabrafenib + Trametinib followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma

Eligible for screening study DCP 001

NCT#02224781

ECOG-ACRIN EA6141

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma, Skin

Status:

Temporarily Closed

Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma

NCT#02339571

Enrollment is on target to reach the accrual goal necessary to conduct a study-specified planned interim analysis per section 9.4 of the protocol. Only patients who have signed a consent to participate on or before 5:00 PM (EST) June 23rd, and for whom registration is completed by 5:00 PM (EST) June 30th, will be accepted, until further notice.

This protocol has additional training requirements to be completed prior to registering any patients at your site.  Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

ECOG-ACRIN EA6174

Primary Category:

Treatment Protocols

Disease Category:

Skin

Status:

New, Open

A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma

NCT#03712605

Eligible for screening study DCP 001

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites.  Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

  • CARIS Life Sciences – 07/02/18
  • CellNetix Pathology and Laboratories – 02/13/19
  • Foundation Medicine – 07/02/18
  • GenPath BioReference Laboratories – 08/03/18
  • The Jackson Laboratory – 01/10/19
  • NeoGenomics Laboratories – 07/02/18
  • OmniSeq Laboratories – 07/16/18
  • PathGroup – 10/29/18
  • Quest Diagnostics Inc. – 05/20/19
  • Strata Oncology – 08/03/18
  • Tempus Laboratories – 07/16/18

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

SWOG S1512

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Skin

Status:

Open

A Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unresectable Desmoplastic Melanoma (DM)

 

NCT#02775851

SWOG S1607

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma, Skin

Status:

Open

A Phase II Study of Combining T-VEC (NSC-785349) and Pembrolizumab (NSC-776864) in Patients with Advanced Melanoma Who Have Progressed on Anti-PD1/L1 Based Therapy

NCT#02965716

Limited institution study: open only to Billings Clinic

SWOG S1614

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT#03887702

SWOG S1616

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma, Skin

Status:

Open

A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti PD-L1 Agent

NCT#03033576

SWOG S1801

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma, Skin

Status:

New, Open

A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk Melanoma

NCT#03698019

Thyroid

AFT-39 PROTECT

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

SWOG S1614

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT#03887702