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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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
  8. Measurable disease as per RECIST version 1.1 criteria
  9. ECOG performance status of 0 or 1

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Active brain metastases or leptomeningeal metastases
  2. Ocular melanoma
  3. Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study Details

Contition
Neoplasms by Site
Age (in years)
18+
Phase
PHASE1/PHASE2
Participants Needed
139
Est. Completion Date
Sep 12, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov NCT Identifier
NCT03656718
Study Number
CA2098KX

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