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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA209-142  |   NCT02060188

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

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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.

Key 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Nivolumab + BMS-986016 Cohort C5

ASSIGNED INTERVENTION
  • Drug: BMS-986016, Nivolumab

Study Arms

Experimental: Nivolumab + Daratumumab Cohort C6

ASSIGNED INTERVENTION
  • Drug: Daratumumab, Nivolumab

Study Arms

Experimental: Nivolumab + Ipilimumab

ASSIGNED INTERVENTION
  • Drug: Nivolumab, Ipilimumab

Study Arms

Experimental: Nivolumab + Ipilimumab + Cobimetinib Cohort C4

ASSIGNED INTERVENTION
  • Drug: Nivolumab, Ipilimumab, Cobimetinib

Study Arms

Experimental: Nivolumab + Ipilimumab Cohort C3

ASSIGNED INTERVENTION
  • Drug: Nivolumab, Ipilimumab

Study Arms

Experimental: Nivolumab Monotherapy

ASSIGNED INTERVENTION
  • Drug: Nivolumab

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