A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread (CheckMate142)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Microsatellite Unstable Colorectal Cancer; Microsatellite Stable Colorectal Cancer; Mismatch Repair Proficient Colorectal Cancer; Mismatch Repair Deficient Colorectal Cancer

Treatments: Drug: Ipilimumab; Drug: BMS-986016; Drug: Daratumumab; Drug: Cobimetinib; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02060188

CA209-142

2013-003939-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 385 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

385 participants in 6 patient groups

Nivolumab Monotherapy

Experimental group

Treatment:

Drug: Nivolumab

Nivolumab + Ipilimumab

Experimental group

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

Nivolumab + Ipilimumab Cohort C3

Experimental group

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

Nivolumab + Ipilimumab + Cobimetinib Cohort C4

Experimental group

Treatment:

Drug: Nivolumab

Drug: Cobimetinib

Drug: Ipilimumab

Nivolumab + BMS-986016 Cohort C5

Experimental group

Treatment:

Drug: Nivolumab

Drug: BMS-986016

Nivolumab + Daratumumab Cohort C6

Experimental group

Treatment:

Drug: Nivolumab

Drug: Daratumumab