Phase 2
N=385
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
Microsatellite Unstable Colorectal Cancer · Microsatellite Stable Colorectal Cancer · Mismatch Repair Proficient Colorectal Cancer · Mismatch Repair Deficient Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02060188 ↗Enrolled (actual)
385
Serious AEs
61.6%
Results posted
Nov 2025
Primary outcome: Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment — 40.5; 66.4; 71.1; 3.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ipilimumab (Drug); Nivolumab (Drug); Cobimetinib (Drug); Daratumumab (Drug); BMS-986016 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment |
40.5; 66.4; 71.1; 3.3; 50.0; 0 | — |
| SECONDARY Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Independent Review Committee (IRC) |
37.8; 61.3; 62.2; 6.7; 50.0; 0 | — |
Summary
The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Histologically confirmed recurrent or metastatic colorectal cancer
- Measurable disease per RECIST v1.1
- Microsatellite instability expression detected by an accredited laboratory
- Participants enrolled into the C3 Cohort must have not had treatment for their metastatic disease
Exclusion Criteria
- Active brain metastases or leptomeningeal metastases are not allowed
- Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Prior malignancy active within the previous 3 years except for locally curable cancers
- Participants with active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02060188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.