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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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Sorry, this study is no longer accepting new participants, but is still ongoing.
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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.

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Key Eligibility Criteria

Inclusion Criteria

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:
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
    1. Histologically confirmed recurrent or metastatic colorectal cancer
      1. Measurable disease per RECIST v1.1
        1. Microsatellite instability expression detected by an accredited laboratory
          1. Participants enrolled into the C3 Cohort must have not had treatment for their metastatic disease

            Exclusion Criteria

            Exclusion Criteria Icon
            :
            • Active brain metastases or leptomeningeal metastases are not allowed
              1. 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
                1. Prior malignancy active within the previous 3 years except for locally curable cancers
                  1. Participants with active, known or suspected autoimmune disease
                    1. 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
                      Additional Information *

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      Study Arms

                      Experimental: Nivolumab + BMS-986016 Cohort C5

                      ASSIGNED INTERVENTION
                      • Drug: Nivolumab, BMS-986016

                      Study Arms

                      Experimental: Nivolumab + Daratumumab Cohort C6

                      ASSIGNED INTERVENTION
                      • Drug: Nivolumab, Daratumumab

                      Study Arms

                      Experimental: Nivolumab + Ipilimumab

                      ASSIGNED INTERVENTION
                      • Drug: Ipilimumab, Nivolumab

                      Study Arms

                      Experimental: Nivolumab + Ipilimumab + Cobimetinib Cohort C4

                      ASSIGNED INTERVENTION
                      • Drug: Ipilimumab, Nivolumab, Cobimetinib

                      Study Arms

                      Experimental: Nivolumab + Ipilimumab Cohort C3

                      ASSIGNED INTERVENTION
                      • Drug: Ipilimumab, Nivolumab

                      Study Arms

                      Experimental: Nivolumab Monotherapy

                      ASSIGNED INTERVENTION
                      • Drug: Nivolumab

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