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Recruitment is currently paused for this study.

Recruiting

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

Updated: 7 February, 2020   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 25

    Location(s)

  • 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: nivolumab (dose 3)
Biological: Nivolumab Drug: rHuPH20

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 - 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 could apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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