Nivolumab, Nivolumab Plus Ipilimumab, or Chemotherapy for Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (CheckMate 8HW)
Clinicaltrials.gov identifier:
NCT04008030
Treatment:
Colorectal
Study Contact Information:
For more information please email Clinical.Trials@bms.com reference NCT04008030 in the subject line and email body.
A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW)
About the Study
The purpose of this study is to compare the benefit of the combination of immunotherapy agents nivolumab (Opdivo) plus ipilimumab (Yervoy) in patients who have Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer versus using nivolumab as a single therapy or chemotherapy.
Type of Study
This is a 3-arm, randomized, open-label, phase 3 study.
- The study has 3-arms
- Patients assigned to Group 1 will receive will receive nivolumab as a single therapy.
- Patients assigned to Group 2 will receive a combination of nivolumab plus ipilimumab.
- Patients assigned to Group 3 will receive their doctor's choice of chemotherapy.
- The study is randomized. Patients will be selected by chance and placed into one of the three groups.
- The study is open-label, all patients will know which group they have been placed into.
What the Study Entails
Group 1 treatment
People in Group 1 will receive nivolumab as a single therapy.
Group 2 treatment
Patients in Group 2 will receive a combination of nivolumab plus ipilimumab.
Group 3 treatment
Patients in group 3 will receive their doctor's choice of chemotherapy agents. Patients in this group would also be allowed to receive the nivolumab + ipilimumab combination therapy if their disease progresses.
Followup
Patients will be followed up to five years.
Study Sites
| California | Colorado | Illinois | New York | Oregon |
| Pennsylvania | Texas | Virginia |
- Sacramento: University of California Davis Medical Center
Contact: May Cho: 916-734-3604
- Denver: Rocky Mountain Cancer Centers
Contact: Allen Cohn: 303-388-0136
- Arlington Heights: Illinois Cancer Specialists
Contact: Richard Siegel, Site 0119
- New York City: Memorial Sloan Kettering Nassau
Contact: Neil Segal, Site 0060 646-888-1396
- Portland: Northwest Cancer Specialists (Broadway) - USOR
Contact: Spencer Shao, Site 0105 503-231-2612
- Pittsburgh: UPMC Hillman Cancer Center
Contact: Anuradha Krishnamurthy, Site 0121 412-623-8364
- Dallas: Texas Oncology Sammons Cancer Center
Contact: Andrew Scott Paulson, Site 0106 214-370-1987
- Roanoke: Oncology & Hematology Associates Of Southwest Virginia, Inc.
Contact: Mark Kochenderfer, Site 0104 540-982-0237
Men and Women, age 18 years or older, are eligible if they have:
- Recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history
OR
- Recurrent or metastatic CRC and no prior treatment history with chemotherapy and/or targeted agents for metastatic disease
- Tumor tissue confirmed as MSI-H or dMMR status
People with a history of the following cannot participate
- An active or suspected autoimmune disease
- History of interstitial lung disease (scarring and inflammation of the tissue that surrounds the lung's air sacs, blood vessels and airways) or pneumonitis (inflammation of the lung tissue)
- History of HIV or AIDS