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Trial ID CA209-8KX  |   NCT03656718

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

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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 the effects of nivolumab when given under the skin with or without rHuPH20. This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy: - non-small cell lung cancer (NSCLC) - renal cell carcinoma (RCC) - unresectable or metastatic melanoma - hepatocellular carcinoma (HCC) - microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC) - in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician - In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types: 1. Metastatic squamous or non-squamous NSCLC 2. RCC, advanced or metastatic 3. Melanoma 4. HCC 5. CRC, metastatic (MSI-H or dMMR) 6. In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor 7. In Part E, Metastatic urothelial carcinoma
    1. Measurable disease as per RECIST version 1.1 criteria
      1. ECOG performance status of 0 or 1

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Active brain metastases or leptomeningeal metastases
          1. Ocular melanoma
            1. Active, known, or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria apply
              Additional Information *

              Treatment Options

              Study Arms

              ASSIGNED INTERVENTION

              Study Arms

              Experimental: Part A, Group 1: nivolumab (dose 1) + rHuPH20

              ASSIGNED INTERVENTION

              Study Arms

              Experimental: Part B, Group 2: nivolumab (dose 1)

              ASSIGNED INTERVENTION

              Study Arms

              Experimental: Part B, Group 3: nivolumab (dose 2) + rHuPH20

              ASSIGNED INTERVENTION

              Study Arms

              Experimental: Part B, Group 4: nivolumab (dose 2)

              ASSIGNED INTERVENTION

              Study Arms

              Experimental: Part C: nivolumab (dose 3) + rHuPH20

              ASSIGNED INTERVENTION
              • Drug: rHuPH20
              • Biological: nivolumab

              Study Arms

              Experimental: Part D, Group 5: nivolumab (dose 3) + rHuPH20

              ASSIGNED INTERVENTION

              Study Arms

              Experimental: Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20

              ASSIGNED INTERVENTION

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