Clinical Trial Details

USOR 18119

Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy

Purpose/Objective

Request Additional Trial Information
Full Trial Details: ClinicalTrials.gov

Condition: Solid Tumors
Study Type: Interventional
Phase: I
Study Start Date: 03/19/2019
Study Completion Date: 10/2024

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 Medical Monitor

 

NCT Number

NCT03656718

Principal Investigator(s)

John Wallmark, MD

Sponsor(s)

Bristol-Myers Squibb

Participant Eligibility

• Age: 18 - No Maximum
• Gender: Male, Female