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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).

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Key Eligibility Criteria

Inclusion Criteria: - 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 - Measurable disease as per RECIST version 1.1 criteria - ECOG performance status of 0 or 1 Exclusion Criteria: - Active brain metastases or leptomeningeal metastases - Ocular melanoma - Active, known, or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria apply

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