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

• Status: Recruiting
• Trial end date: 2025-07-14
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Nivolumab

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

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 could apply