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:

INCLUSION CRITERIA

Inclusion Criteria:

Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types:

Metastatic squamous or non-squamous NSCLC
RCC, advanced or metastatic
Melanoma
HCC
CRC, metastatic (MSI-H or dMMR)
In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor
In Part E, Metastatic urothelial carcinoma
Measurable disease as per RECIST version 1.1 criteria
ECOG performance status of 0 or 1

EXCLUSION CRITERIA

Exclusion Criteria:

Active brain metastases or leptomeningeal metastases
Ocular melanoma
Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply

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’s details

Contition

Neoplasms by Site

Age (in years)

18+

Phase

Phase 1/Phase 2

Participants needed

140

Est. Completion Date

Mar 7, 2025

Treatment type

Interventional

Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov identifier

NCT03656718

Study number

CA2098KX

Understanding Clinical Trials

Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?