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
Phase of Trial: Phase I/II
Latest Information Update: 06 Jan 2020
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At a glance
- Drugs Cetrelimab (Primary) ; Erdafitinib (Primary)
- Indications Carcinoma; Urogenital cancer
- Focus Adverse reactions; Therapeutic Use
- Acronyms NORSE
- Sponsors Janssen Research & Development; Janssen-Cilag
- 05 Dec 2019 Planned End Date changed from 17 Jun 2021 to 22 Sep 2021.
- 18 Oct 2019 Planned primary completion date changed from 21 Oct 2019 to 17 Jun 2021.
- 21 Jun 2019 Planned number of patients changed from 115 to 150.