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

Clinical Trial Details

USOR 18119

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

Purpose/Objective

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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

Location

  • Shady Grove Adventist Aquilino Cancer Center
    9905 Medical Center Drive
    Rockville, MD 20850
    Main: 240-826-6297

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