A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib plus JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Metastatic or Surgically Unresectable Urothelial Cancer with Selected FGFR Gene

Clinical Trial Details

This clinical trial is for men and women with advanced urothelial cancer. The purpose of this study is to research the effects (both good and bad) of two investigational drugs called erdafitinib and JNJ-63723283. All patients enrolled in this study will receive either erdafitinib alone or in combination with JNJ-63723283 depending on the time of enrollment. Erdafitinib is taken by mouth every day. JNJ-63723283 is taken via IV infusion once every 2 weeks. 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
Previous treatment for metastatic disease (disease which has spread to other parts of the body)
Detailed eligibility reviewed when you contact the study team

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Amie Patel, RN
212-746-1480
amp3002@med.cornell.edu

Angela Tan, RN
212-746-4154
ant4009@med.cornell.edu

Primary Investigator(s)

Scott T. Tagawa, MD, MS (UES)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1801018918

ClinicalTrials.gov:

NCT03473743

Status

Open to Enrollment

Age Group

Adult

Disease

Cancer

Bladder and other Urothelial Cancers