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

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 A071701

Primary Category:

Treatment Protocols

Disease Category:

Brain, Brain Metastatic, Molecular Profiling

Status:

New, Open

Genomically-Guided Treatment Trial in Brain Metastases

ALLIANCE A071801

Primary Category:

Radiation Oncology

Disease Category:

Brain, Brain Metastatic

Status:

New, Open

Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

NCT#04114981

ALLIANCE CCTG CE.7

Primary Category:

Radiation Oncology

Disease Category:

Brain, Brain Metastatic

Status:

Open

A Phase III Trial of Stereotactic Radiosurgery Compared with Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5-15 Brain Metastases

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

NCT#03550391

CCTG CE.7 has reopened with Amendment 1 to resume patient accrual at your center, your site will be required to provide confirmation of HA-WBRT credentialing and approval by IROC.

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

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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

(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:

Temporarily Closed

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

Temporary closure to new accrual effective May 28, 2020.  Reopening pending approval of protocol amendment to increase accrual goal.

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:

Temporarily Closed

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

S1614 is temporally closed to accrual effective May 20, 2020.  

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

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.

Email aboerner@mtcancer.org for additional QOLs and resources in Spanish.

ALLIANCE A011202

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

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

A011202 is re-opened to new patient pre-registration effective May 15, 2020. 

NCT#01901094

ALLIANCE A011401

Primary Category:

Cancer Control and Prevention Protocols, Treatment 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 A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

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 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:

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 A221702

Primary Category:

Surgical Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

New, Open

ARM: Axillary Reverse Mapping – A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence After Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection With and Without Axillary Reverse Mapping

Eligible for screening study DCP 001

ALLIANCE A231701CD

Primary Category:

Cancer Care Delivery, Surgical Protocols

Disease Category:

Breast, Cancer Care Delivery

Status:

Temporarily Closed

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

NCT#03766009

Due to concerns regarding the spread of the novel coronavirus and the impact it is having on hospitals, clinics, physician offices, and patients’ ability to travel, the study will be temporarily suspended to new patient accrual, effective immediately, March 23, 2020.

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 EA1181

Primary Category:

Treatment Protocols

Disease Category:

Breast

Status:

New, Open

(CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response Part 1 Component of: The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer)

 

NCT#04266249

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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

(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:

Temporarily Closed

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

Effective, Friday, September 13th, 2019, study NRG BR002 is temporarily closed to accrual at 3 p.m. MST.

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:

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 today, July 2, 2019, study NRG BR005 is temporarily closed to accrual.

NRG CCTG MA.39

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

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 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.

Effective today, January 28, 2020, the BAHO substudy for SWOG study S1418/BR006,  is temporarily 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 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:

Temporarily Closed

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

S1614 is temporally closed to accrual effective May 20, 2020.  

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:

Open

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

NCT#03598257

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

Cancer Care Delivery

ALLIANCE A231701CD

Primary Category:

Cancer Care Delivery, Surgical Protocols

Disease Category:

Breast, Cancer Care Delivery

Status:

Temporarily Closed

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

NCT#03766009

Due to concerns regarding the spread of the novel coronavirus and the impact it is having on hospitals, clinics, physician offices, and patients’ ability to travel, the study will be temporarily suspended to new patient accrual, effective immediately, March 23, 2020.

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

The “Colon Cancer, Receiving Chemotherapy” (or Colon/Chemo) cohort closed to accrual on May 2, 2019.  The “Rectal Cancer, Receiving Chemotherapy” or (Rectal/Chemo) re-opened to accrual on August 26, 2019.

The “Colon Cancer, not receiving chemotherapy” (Colon/No-Chemo) cohort will be closed to  accrual, effective April 1, 2020, as it is nearing its accrual thresholds.

ECOG-ACRIN EAQ171CD

Primary Category:

Cancer Care Delivery

Disease Category:

Cancer Care Delivery

Status:

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.

Gastrointestinal

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 A021703

Primary Category:

Treatment Protocols

Disease Category:

Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic

Status:

New, Open

Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

Eligible for screening study DCP 001

NCT#04094688

ALLIANCE A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

ALLIANCE A221701

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal

Status:

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 A221805

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Colon, Gastrointestinal, Rectal

Status:

New, Open

Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study

 

Eligible for screening study DCP 001

NCT#04137107

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 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 EA2182

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Anal, Gastrointestinal

Status:

New, Open

A Randomized Phase II Study of De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE)

NCT#04166318

ECOG-ACRIN EA2183

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Esophageal, Esophageal Metastatic, Gastrointestinal, Stomach, Stomach Metastatic

Status:

New, Open

A Phase III Study of Consolidative Radiotherapy in Patients with Oligometastatic HER2 Negative Esophageal and Gastric Adenocarcinoma (EGA)

NCT#04248452

Eligible for screening study DCP 001

ECOG-ACRIN EA2187

Primary Category:

Treatment Protocols

Disease Category:

Cholangiocarcinoma, Gastrointestinal

Status:

New, Open

A Phase 2 Study of Pevonedistat in Combination with Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma

 

NCT#04175912

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

The “Colon Cancer, Receiving Chemotherapy” (or Colon/Chemo) cohort closed to accrual on May 2, 2019.  The “Rectal Cancer, Receiving Chemotherapy” or (Rectal/Chemo) re-opened to accrual on August 26, 2019.

The “Colon Cancer, not receiving chemotherapy” (Colon/No-Chemo) cohort will be closed to  accrual, effective April 1, 2020, as it is nearing its 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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

(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.

As of Tuesday, May 14th, 2019 at 9:00 am EST, NRG-GI002 (Arm 1 and 3) 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:

Temporarily Closed

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

NRG GI004 is temporarily closed to accrual effective June 4, 2020 5pm EDT ,

NCT#02997228

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

NRG GI005

Primary Category:

Treatment Protocols

Disease Category:

Colon, Gastrointestinal

Status:

New, Open

Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)

NCT#04068103

SWOG S1613

Primary Category:

Treatment Protocols

Disease Category:

Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic

Status:

Open

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

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:

Temporarily Closed

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

S1614 is temporally closed to accrual effective May 20, 2020.  

SWOG S1815

Primary Category:

Treatment Protocols

Disease Category:

Cholangiocarcinoma, Gallbladder, Gastrointestinal

Status:

Temporarily Closed

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

Eligible for screening study DCP 001

NCT#03768414

Effective, March 5th, 2020, study S1815 will be temporarily closed to accrual of new patients.  Accrual will re-open after the revision for the accrual goal increase is approved and distributed.

SWOG S1820

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Colon, Gastrointestinal, Rectal

Status:

New, Open

A Randomized Trial of the Altering Intake, Managing Symptoms Intervention for Bowel Dysfunction in Rectal Cancer Survivors Compared to a Healthy Living Education Control: A Feasibility and Preliminary Efficacy Study (AIMS-RC)

NCT#04205955

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

SWOG S1922

Primary Category:

Treatment Protocols

Disease Category:

Gastrointestinal, Small Bowel

Status:

New, Open

Randomized Phase II Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma

NCT#04205968

Genitourinary

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:

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:

Open

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

ALLIANCE A031702

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary, Prostate, Renal

Status:

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:

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 A031801

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Renal, Renal Metastatic

Status:

New, Open

A Phase II Randomized Trial of Radium-223 Dichloride and Cabozantinib in Patients with Advanced Renal Cell Carcinoma with Bone Metastasis (RadiCal)

NCT#04071223

ALLIANCE A031803

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

New, Open

Phase II Trial of Intravesical Gemcitabine and MK-3475 (Pembrolizumab) in the Treatment of Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

NCT#04164082

ALLIANCE A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

ALLIANCE A221701

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal

Status:

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

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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

(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 GU007

Primary Category:

Radiation Oncology

Disease Category:

Genitourinary, Prostate

Status:

Open

Randomized Phase II Trial of Niraparib With Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I)

 

NCT#04037254

GU007 is reopened to accrual to Phase I, Dose Level 1 effective May 4, 2020.

NRG GU008

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

New, Open

Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide and Advanced Imaging Into Salvage Treatment for Patients with Node-Positive Prostate Cancer After Radical Prostatectomy

NCT#04134260

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 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:

Temporarily Closed

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

S1614 is temporally closed to accrual effective May 20, 2020.  

SWOG S1802

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Genitourinary, Prostate, Prostate Metastatic

Status:

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:

Open

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

NCT#03775265

 

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

Gynecologic

ALLIANCE A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

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

GOG Foundation GOG-3024/GCT1015-05

Primary Category:

Treatment Protocols

Disease Category:

Cervical, Cervical Metastatic, Gynecologic

Status:

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 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 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:

Temporarily Closed

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

Effective today, June 17th, 2019, study NRG GY012 has met its accrual goal and is temporarily closed.

NRG GY014

Primary Category:

Treatment Protocols

Disease Category:

Endometrial, Gynecologic, Ovarian

Status:

Temporarily Closed

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:

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 GY018

Primary Category:

Treatment Protocols

Disease Category:

Endometrial, Gynecologic

Status:

New, Temporarily Closed

A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVB or Recurrent Endometrial Cancer

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.

NRG Oncology GY018 is temporarily being suspended to accrual in response to the COVID-19 pandemic while we consider options to responsibly continue the trial in the context of the current placebo design.  Patients who have already consented and/or entered Step 1 registration will be allowed to proceed.  Step 1 registration must be completed for all consented patients by 12 Noon ET, Monday, April 6, 2020.

NCT#03914612

NRG GY019

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian, Ovarian Metastatic

Status:

New, Open

A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

Eligible for screening study DCP 001

NRG GY020

Primary Category:

Cancer Care Delivery, Radiation Oncology

Disease Category:

Endometrial, Gynecologic

Status:

New, Open

A Phase III Randomized Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

Eligible for screening study DCP 001

NCT#04214067

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:

Temporarily Closed

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

S1614 is temporally closed to accrual effective May 20, 2020.  

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

Head and Neck

ALLIANCE A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

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 EA3161

Primary Category:

Treatment Protocols

Disease Category:

Head and Neck

Status:

Open

Nivolumab Versus Observation in Treating Patients With Locally Advanced, Intermediate Risk HPV-Positive Oropharyngeal Cancer

NCT#03811015

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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

(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

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

NRG HN005

Primary Category:

Radiation Oncology

Disease Category:

Head and Neck

Status:

New, Open

A Randomized Phase II/II Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

Open to Phase II enrollment

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:

Temporarily Closed

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

S1614 is temporally closed to accrual effective May 20, 2020.  

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

Leukemia

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

Confirmation of Tolerability Phase and slot reservation completed and study currently open to Phase III enrollment as of 06/12/2018.  See Section 4.4 for registration and randomization instructions.

ALLIANCE A041701

Primary Category:

Treatment Protocols

Disease Category:

Acute Myeloid Leukemia, Leukemia

Status:

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:

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

ALLIANCE A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

ALLIANCE A231602CD

Primary Category:

Cancer Care Delivery

Disease Category:

Chronic Lymphocytic Leukemia, Leukemia, Multiple Myeloma

Status:

New, Open

Assessing Financial Difficulty in Patients with Blood Cancers

NCT#03870633

Eligible for screening study DCP 001

Limited site participation.  Open only to Benefis Sletten Cancer Institute, Billings Clinic, Community Hospital of Anaconda, Community Medical Center, and Saint Alphonsus Regional Medical Center

ECOG-ACRIN EA9161

Primary Category:

Treatment Protocols

Disease Category:

Chronic Lymphocytic Leukemia, Leukemia

Status:

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:

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.

Suspension to enrollment of new participants and follow-up research sample collection and shipment is lifted effective May 18, 2020, for NHLBI-MDS.  Refer to memo dated March 27, 2020, on conducting remote follow-up data for enrolled participants.

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:

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

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

Lung

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

Effective, August 26, 2019, enrollment is temporarily suspended for patients with squamous histology.

NCT#02194738

ALLIANCE A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

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

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 EA5162

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Temporarily Closed

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

NCT#03191149

Effective, July 2, 2019, study EA5162 is temporarily closed to accrual.

ECOG-ACRIN EA5163

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

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

Eligible for screening study DCP 001

ECOG-ACRIN EA5181

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell

Status:

New, Open

Randomized Phase III Trial of MEDI4736 (Durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC

 

Eligible for screening study DCP 001

NCT#04092283

ECOG-ACRIN EA5191

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell Metastatic

Status:

New, Open

A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients with Previously Treated Non-Squamous NSCLC

NCT#04310007

 

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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

(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:

Temporarily Closed

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

Temporary closure to new accrual effective May 28, 2020.  Reopening pending approval of protocol amendment to increase accrual goal.

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:

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 Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consents & for any questions.

NRG LU004

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell

Status:

Temporarily Closed

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

LU004 is temporarily closed to accrual effective immediately, April 13, 2020. The study has enrolled 6 patients to Cohort 2 (the standard radiation + MEDI4736 (durvalumab) arm) and will be temporarily closed while the safety of the protocol treatment regimen in both cohorts is monitored.

NRG LU005

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

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

Status:

Open

Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

Site staff must complete Rave ePro online training prior to the first patient enrollment.

NCT#03811002

SWOG LUNGMAP

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Open

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

NCT#03851445

Eligible for screening study DCP 001

Effective, June 30th, 2019, the sub-study S1400GEN is closed to accrual.

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:

Temporarily Closed

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

S1614 is temporally closed to accrual effective May 20, 2020.  

SWOG S1800A

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Open

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#03971474

SWOG S1827

Primary Category:

Radiation Oncology

Disease Category:

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

Status:

New, Open

MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

Eligible for screening study DCP 001

NCT#04155034

SWOG S1900A

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

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

SWOG S1900B

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

New, Open

A Phase II Study of LOXO-292 in Patients with RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)

NCT#04268550

See Screening Protocol LUNGMAP

SWOG S1900C

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

New, Open

A Phase II Study of Talazoparib Plus Avelumab in Patients with Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer Bearing Pathogenic STK11 Genomic Alterations (LUNG-MAP Sub-Study)

NCT#04173507

 

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

Lymphoma

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:

Open

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

This study is open to FACT-accredited institutions only.

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

ALLIANCE A051701

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

New, Open

Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas

NCT#03984448

 

ALLIANCE A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

ECOG-ACRIN E4412

Primary Category:

Treatment Protocols

Disease Category:

Hodgkin Lymphoma, Lymphoma

Status:

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 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 EA4181

Primary Category:

Treatment Protocols

Disease Category:

Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin Lymphoma

Status:

New, Open

A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients <= 70 Years Old with Untreated Mantle Cell Lymphoma

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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

(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

SWOG S1826

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Hodgkin Lymphoma, Lymphoma

Status:

New, Open

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

NCT#03907488

Eligible for screening study DCP 001

 

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

Molecular Profiling

ALLIANCE A071701

Primary Category:

Treatment Protocols

Disease Category:

Brain, Brain Metastatic, Molecular Profiling

Status:

New, Open

Genomically-Guided Treatment Trial in Brain Metastases

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

Effective, August 26, 2019, enrollment is temporarily suspended for patients with squamous histology.

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 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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

(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

ECOG-ACRIN EAY131-C1

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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

(See required screening study ECOG-ACRIN EAY131)

EAY131 C1 substudy, is reactivated, May 7, 2020, to allow for expanded accrual.

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-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-J

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Temporarily Closed

MATCH Treatment Subprotocol J: Trastuzumab and Pertuzumab (HP) in Patients with Non-Breast, Non-Gastric/GEJ Cancers with HER2 Amplification

(See required screening study ECOG-ACRIN EAY131)

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 June 14, 2019, sub-study EAY131-J is temporarily closed to accrual.

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:

Open

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)

EAY131 Subprotocol M, is reactivated, May 7, 2020, with expanded accrual.

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-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:

Open

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 reactivated, May 7, 2020, to allow for expanded accrual.

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:

Temporarily Closed

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.

Effective today, January 8th, 2020, EAY131 (MATCH) Subprotocol Z1H-Phase II is suspended and no new patients will be assigned to this treatment arm.  Patients who are currently being treated on this subprotocol will continue on the study with no changes in their participation.

NCT#02465060

ECOG-ACRIN EAY131-Z1K

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling, Other

Status:

Open

Molecular Analysis for Therapy Choice – Phase 2 Study of the Selective ATP-Competitive Inhibitor Ipatasertib (GDC-0068) in Patients with Tumors with AKT Mutation

(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-Z1L

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling, Other

Status:

Open

Molecular Analysis for Therapy Choice – Phase 2 Study of BVD-523 (Ulixertinib) in Patients with Tumors with BRAF Fusions, or with Non-V600E, Non-V600K BRAF 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

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

ALLIANCE A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

ALLIANCE A231602CD

Primary Category:

Cancer Care Delivery

Disease Category:

Chronic Lymphocytic Leukemia, Leukemia, Multiple Myeloma

Status:

New, Open

Assessing Financial Difficulty in Patients with Blood Cancers

NCT#03870633

Eligible for screening study DCP 001

Limited site participation.  Open only to Benefis Sletten Cancer Institute, Billings Clinic, Community Hospital of Anaconda, Community Medical Center, and Saint Alphonsus Regional Medical Center

ECOG-ACRIN EAA173

Primary Category:

Treatment Protocols

Disease Category:

Multiple Myeloma

Status:

New, Open

Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

Eligible for screening study DCP 001

NCT#03937635

NRG BR002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Temporarily Closed

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

Effective, Friday, September 13th, 2019, study NRG BR002 is temporarily closed to accrual at 3 p.m. MST.

NCT#02364557

NRG BR004

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

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 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

SWOG S1803

Primary Category:

Treatment Protocols

Disease Category:

Multiple Myeloma

Status:

New, Open

Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

Eligible for screening study DCP 001

Occupational Report & Pregnancy Report consent forms available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consents and for any questions.

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

Neuroendocrine

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 A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

ALLIANCE A221701

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal

Status:

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 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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

(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:

Temporarily Closed

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

S1614 is temporally closed to accrual effective May 20, 2020.  

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

Other

ALLIANCE A011401

Primary Category:

Cancer Control and Prevention Protocols, Treatment 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 A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

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

ECOG-ACRIN EAY131-Z1K

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling, Other

Status:

Open

Molecular Analysis for Therapy Choice – Phase 2 Study of the Selective ATP-Competitive Inhibitor Ipatasertib (GDC-0068) in Patients with Tumors with AKT Mutation

(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-Z1L

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling, Other

Status:

Open

Molecular Analysis for Therapy Choice – Phase 2 Study of BVD-523 (Ulixertinib) in Patients with Tumors with BRAF Fusions, or with Non-V600E, Non-V600K BRAF 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

NCICOVID

Primary Category:

Treatment Protocols

Disease Category:

Other

Status:

New, Open

NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study

Eligible for screening study DCP 001

NCT#04387656

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 today, July 2, 2019, study NRG BR005 is temporarily closed to accrual.

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:

Temporarily Closed

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

S1614 is temporally closed to accrual effective May 20, 2020.  

SWOG S1701

Primary Category:

Treatment Protocols

Disease Category:

Other

Status:

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

Sarcoma

ALLIANCE A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

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

NRG DT001

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Sarcoma

Status:

Temporarily Closed

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

NCT#03217266

Effective, April 24th, 2020, NRG DT001, Cohort B, is reactivated to Dose Level 2.
Cohort A (extremity/body wall) at Dose level 3 remains open.

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:

Temporarily Closed

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

S1614 is temporally closed to accrual effective May 20, 2020.  

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

Skin

ALLIANCE A091802

Primary Category:

Treatment Protocols

Disease Category:

Skin

Status:

Open

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

NCT#03944941

ALLIANCE A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

ECOG-ACRIN EA6134

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma, Skin

Status:

Open

DREAMseq (Doublet, Randomized Evaluation in Advanced Melanoma Sequencing) a Phase III Trial

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:

Open

STAMP: Surgically Treated Adjuvant Merkel cell carcinoma with Pembrolizumab, a Phase III Trial

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

The Biopsy consent form for this study is available upon request.  Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

(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

Cohort B permanently closed to accrual effective June 1, 2020.  Cohort A (patients with at least one visceral lesion) will remain open.

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:

Temporarily Closed

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

S1614 is temporally closed to accrual effective May 20, 2020.  

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:

Open

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

NCT#03698019

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.

 

Thyroid

ALLIANCE A151804

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Other, Sarcoma, Skin, Thyroid

Status:

New, Open

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

NCT#04242095

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:

Temporarily Closed

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

S1614 is temporally closed to accrual effective May 20, 2020.  

SWOG S1916

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid

Status:

Upcoming - Pending IRB Review

Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

Limited site participation.  Open only to Billings Clinic.

Please see the SWOG website for any study documents not found here on the MCC website.