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Active, Not Recruiting

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) - CA209-8KX

Updated: 6 December, 2023   |   ClinicalTrials.gov

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Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part A, Group 1: nivolumab (dose 1) + rHuPH20
Experimental: Part B, Group 2: nivolumab (dose 1)
Experimental: Part B, Group 3: nivolumab (dose 2) + rHuPH20
Experimental: Part B, Group 4: nivolumab (dose 2)
Experimental: Part C: nivolumab (dose 3) + rHuPH20
Drug: rHuPH20 Biological: nivolumab
Experimental: Part D, Group 5: nivolumab (dose 3) + rHuPH20
Experimental: Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20

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

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