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

Completed · Phase 1/Phase 2

Conditions studied: Neoplasms by Site

In brief

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).

Key facts

Study ID

NCT03656718

Run by

Bristol-Myers Squibb

People needed

139

Starts

2018-10-29

Expected to finish

2024-09-12

Last updated by the study team

2025-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Active brain metastases or leptomeningeal metastases
• Ocular melanoma
• Active, known, or suspected autoimmune disease
• Other protocol defined inclusion/exclusion criteria apply

Where it is running

• Winship Cancer Institute. — Atlanta, Georgia, United States
• Local Institution - 0024 — Rockville, Maryland, United States
• Local Institution - 0020 — Detroit, Michigan, United States
• Local Institution - 0001 — Charlotte, North Carolina, United States
• Local Institution - 0012 — Eugene, Oregon, United States
• Greenville Health System — Greenville, South Carolina, United States
• Local Institution - 0010 — Austin, Texas, United States
• Local Institution - 0009 — Beaumont, Texas, United States
• Local Institution - 0007 — Dallas, Texas, United States
• Local Institution - 0011 — Tyler, Texas, United States
• Local Institution - 0035 — CABA, Argentina
• Local Institution - 0025 — CABA, Argentina
• Local Institution - 0038 — Porto Alegre, Rio Grande do Sul, Brazil
• Local Institution - 0037 — São Paulo, Brazil
• Local Institution - 0005 — Santiago, Chile
• Local Institution - 0022 — Saint-Herblain, France
• Local Institution - 0021 — Villejuif, France
• Local Institution - 0003 — Rozzano, MI, Italy
• Local Institution - 0004 — Padova, Italy
• Local Institution - 0050 — Mexico City, Mexico City, Mexico
• Local Institution - 0048 — Mexico City, Mexico City, Mexico
• Local Institution - 0046 — Monterrey, Nuevo León, Mexico
• Local Institution - 0047 — Monterrey, Nuevo León, Mexico
• Local Institution - 0049 — Puebla City, Mexico
• Local Institution - 0045 — Querétaro, Mexico

Full record on ClinicalTrials.gov

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