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Trial ID CA209-9N9  |   NCT03377361

An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread

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Summary

  • Phase 1/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 investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Histologically or cytologically confirmed previously treated metastatic colorectal cancer with adenocarcinoma histology and in Stage IV per American Joint Committee on Cancer (version 4.0) at study entry
    1. Microsatellite status should be performed per local standard of practice, immunohistochemistry (IHC) and/or PCR. If IHC results are equivocal, PCR is required for determining microsatellite stable (MSS) status
      1. Must have measurable disease per RECIST 1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
        1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at screening and on cycle 1 day 1 (C1D1)

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • BRAF V600 mutant colorectal cancer
            1. Active brain metastases or leptomeningeal metastases
              1. Active, known or suspected autoimmune disease
                1. Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
                  1. History of interstitial lung disease or pneumonitis
                    1. Prior treatment with immune checkpoint inhibitors and mitogen-activated protein kinase enzymes (MEK) inhibitors
                      1. History of allergy or hypersensitivity to study drug components Other protocol defined inclusion/exclusion criteria apply
                        Additional Information *

                        Treatment Options

                        Study Arms

                        ASSIGNED INTERVENTION

                        Study Arms

                        Experimental: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib

                        ASSIGNED INTERVENTION
                        • Biological: Nivolumab
                        • Drug: Trametinib

                        Study Arms

                        Experimental: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib

                        ASSIGNED INTERVENTION
                        • Biological: Nivolumab, Ipilimumab
                        • Drug: Trametinib

                        Study Arms

                        Experimental: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib

                        ASSIGNED INTERVENTION
                        • Biological: Nivolumab, Ipilimumab
                        • Drug: Trametinib

                        Study Arms

                        Experimental: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib

                        ASSIGNED INTERVENTION
                        • Biological: Nivolumab, Ipilimumab
                        • Drug: Trametinib

                        Study Arms

                        Experimental: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib

                        ASSIGNED INTERVENTION
                        • Biological: Nivolumab, Ipilimumab
                        • Drug: Trametinib

                        Study Arms

                        Experimental: Part 2 Cohort 5 (3L): Regorafenib

                        ASSIGNED INTERVENTION
                        • Drug: Regorafenib

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