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A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Clinical Trial Details

This clinical trial is for men and women with advanced urothelial cancer. The purpose of this study is to compare the effects of an investigational drug called erdafitinib to those of docetaxel or vinflunine (chemotherapy) and of pembrolizumab (immunotherapy). The treatment group will be selected by chance (like flipping a coin) by a computer program. Depending on previous treatments, there will be a 50% chance of being allocated to the erdafitinib and a 50% chance of being allocated to the chemotherapy or immunotherapy. Participants in the chemotherapy or immunotherapy arms will receive treatment intravenously every 3 weeks. Participants receiving erdafitinib will take the tablet by mouth every day. Participants will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects. 

Key Eligibility: 
  • Men and women age 18 and older 
  • Urothelial cancer with specific gene mutations 
  • One previous treatment for metastatic disease (disease which has spread to other parts of the body) 
  • Detailed eligibility reviewed when you contact the study team 

Study contact by location

Upper East Side - Manhattan


Amie Patel, RN

Angela Tan, RN

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:




Open to Enrollment

Age Group