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)
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT04008030
This study evaluates nivolumab, alone or with ipilimumab, versus chemotherapy in MSI-H/dMMR mCRC. Eligible participants have recurrent/metastatic CRC, MSI-H/dMMR status, and ECOG ≤1. Exclusions include autoimmune diseases and HIV/AIDS. Interventions include ipilimumab, oxaliplatin, leucovorin, fluorouracil, irinotecan, bevacizumab, cetuximab, and nivolumab.
Patient Parameters
| Parameter | Options |
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Program Overview
The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study)
- Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery (Applicable during Part 2 enrollment of the study)
- Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice
- Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1
Exclusion Criteria
- An active, known or suspected autoimmune disease
- History of interstitial lung disease or pneumonitis
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Other protocol-defined inclusion/exclusion criteria apply
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| Local Institution - 0059 | 90033 | Los Angeles | California |
| Local Institution - 0130 | 95817 | Sacramento | California |
| Local Institution - 0103 | 80218 | Denver | Colorado |
| Local Institution | 33136 | Miami | Florida |
| Local Institution | 30060 | Marietta | Georgia |
| Local Institution - 0119 | 60005 | Arlington Heights | Illinois |
| Local Institution - 0060 | 10065 | New York | New York |
| Local Institution - 0105 | 97227 | Portland | Oregon |
| Local Institution | 19104 | Philadelphia | Pennsylvania |
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