Study of subcutaneous nivolumab monotherapy with or without Recombinant Human Hyaluronidase PH20 (rHuPH20)

Phase 1

Recruiting

• Conditions: lung cancer; kidney cancer; melanoma; liver cancer; colorectal cancer; bladder cancer; MedDRA version: 20.0Level: LLTClassification code: 10064467Term: Urothelial carcinoma Class: 10029104; MedDRA version: 21.0Level: PTClassification code: 10061451Term: Colorectal cancer Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10073071Term: Hepatocellular carcinoma Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code: 10027481Term: Metastatic melanoma Class: 10029104

• Registration Number: CTIS2023-503554-12-00
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-23
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 220

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) Renal Cell Carcinoma, advanced or metastatic 3) Melanoma 4) Hepatocellular Carcinoma 5) Colorectal Cancer, metastatic (MSI-H or dMMR) 6) Urothelial carcinoma , metastatic(part E only), - 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified