A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib Plus JNJ-63723283 (Cetrel

Clinical Trial Details

USOR 17165

A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib Plus JNJ-63723283 (Cetrelimab), an Anti-PD-1 Monoclonal Antibody, in Subjects With Metastatic or Locally Advanced Urothelial Cancer With Selected FGFR Gene Alterations

Purpose/Objective

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Full Trial Details: ClinicalTrials.gov

Condition: Urothelial Cancer
Study Type: nterventional
Phase: I
Study Start Date: 04/13/2018
Study Completion Date: 06/2021

The purpose of this study is to identify the recommended Phase 2 dose (RP2D) and schedule of erdafitinib in combination with cetrelimab (Phase 1b) and to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in first line metastatic urothelial carcinoma (mUC) setting (Phase 2).

 

 

NCT Number
NCT03473743
Principal Investigator(s)
Manish Agarwal, MD
Sponsor(s)
Janssen Research & Development, LLC
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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