A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and Non-MSI-H Colon Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 385
- Locations
- 32
- Primary Endpoint
- Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Nivolumab Monotherapy
Intervention: Nivolumab (Drug)
Nivolumab + Ipilimumab
Intervention: Ipilimumab (Drug)
Nivolumab + Ipilimumab
Intervention: Nivolumab (Drug)
Nivolumab + Ipilimumab Cohort C3
Intervention: Ipilimumab (Drug)
Nivolumab + Ipilimumab Cohort C3
Intervention: Nivolumab (Drug)
Nivolumab + Ipilimumab + Cobimetinib Cohort C4
Intervention: Ipilimumab (Drug)
Nivolumab + Ipilimumab + Cobimetinib Cohort C4
Intervention: Nivolumab (Drug)
Nivolumab + Ipilimumab + Cobimetinib Cohort C4
Intervention: Cobimetinib (Drug)
Nivolumab + BMS-986016 Cohort C5
Intervention: Nivolumab (Drug)
Nivolumab + BMS-986016 Cohort C5
Intervention: BMS-986016 (Drug)
Nivolumab + Daratumumab Cohort C6
Intervention: Nivolumab (Drug)
Nivolumab + Daratumumab Cohort C6
Intervention: Daratumumab (Drug)
Outcomes
Primary Outcomes
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
Time Frame: From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months)
Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \\\[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\\\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Secondary Outcomes
- Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Independent Review Committee (IRC)(From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months))