For Healthcare Professionals

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


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).

Who can take part

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


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


  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

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How to Apply

Contact the study center to learn if this study is a good match for you.
Phone iconCall 855-907-3286Email iconEmail Study Center

Study’s details


Neoplasms by Site




Phase 1/Phase 2

Participants needed


Est. Completion Date

Mar 2025

Treatment type



Bristol-Myers Squibb identifier


Study number


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