Title: A phase 3 randomized clinical trial of nivolumab alone, nivolumab in combination with ipilimumab, or investigator’s choice chemotherapy in participants with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer
Responsible Party: Bristol-Myers Squibb
Description: Researchers are conducting a phase 3 trial to compare nivolumab monotherapy, nivolumab plus ipilimumab, and investigator’s choice of chemotherapy in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR), recurrent or metastatic colorectal cancer.
Patients in arm A will receive nivolumab monotherapy, patients in arm B will receive nivolumab plus ipilimumab, and patients in arm C will receive a standard chemotherapy regimen of the investigator’s choice. If patients in arm C experience disease progression, they will be allowed to receive nivolumab in combination with ipilimumab.
The co-primary endpoints of this trial are progression-free survival (PFS) by blinded independent central review (BICR) in arm A vs arm B and in arm B vs arm C. Secondary endpoints include overall response rate, overall survival, and PFS comparisons between the different arms by both investigator assessment and BICR.
To be eligible for this trial, patients must be 18 years of age or older. They must have a histologically confirmed diagnosis of recurrent or metastatic colorectal cancer with known MSI-H or dMMR status. For a complete list of eligibility criteria, please see the reference.
This trial is sponsored by Bristol-Myers Squibb and Ono Pharmaceutical Co. Ltd.
ClinicalTrials.gov. 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). NCT04008030. Accessed March 23, 2023.