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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 Alterations.

The purpose of this study is to see whether taking the drug Erdafitinib and the drug JNJ-63723283 is safe and effective in treating patients with advanced bladder cancer.
Kathleen Rizzo at kar23@psu.edu or 717-531-0003, ext=289630
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03473743
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Inclusion Criteria:
≥18 years of age.
Histologic demonstration of transitional cell carcinoma of the urothelium.
Stage IV disease (metastatic or surgically unresectable, cT4b, N+, or M+ cancer).
Meet appropriate molecular eligibility criteria
Documented progression of disease per RECIST 1.1, defined as any progression that requires a change in treatment, prior to randomization.
Exclusion Criteria:
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, subjects who have received the following prior antitumor therapy
Chemotherapy within 3 weeks of Cycle 1 Day 1
Prior anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy
Active malignancies (ie, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that are considered completely cured).
Symptomatic central nervous system metastases.
Cancer
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Study Locations

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Location
Hershey, PA