Last updated on December 2018

Fierce-22: A Phase 1b/2 Study of Vofatamab (B-701) in Combination with Pembrolizumab in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma

Brief description of study

The FIERCE-22 study is a Phase 1b/2 study to evaluate the effectiveness and safety of vofatamab (B-701) in combination with the immunotherapy drug pembrolizumab in the treatment of subjects with Stage IV, locally advanced or metastatic FGFR3 wild-type (WT) or mutation positive UCC who have previously been treated with a platinum-based chemotherapy for their bladder cancer which gotten worse or has come back or are not eligible for cisplatin-containing chemotherapy. 

This study is currently in Phase 2. The study has a FGFR3 WT Cohort and a FGFR3 mutant Cohort. Subjects in both cohorts will receive 1 cycle of vofatamab (B701) monotherapy followed by cycles of combination therapy with vofatamab (B701) plus pembrolizumab. Subjects enrolling in the FGFR3 mutant Cohort must have tumors with FGFR3 mutations or gene fusions.

FGFR3 mutation and/or fusion positive status is determined by completing a tumor profile and/or comprehensive cancer genetic test. Testing to determine your FGFR3 status is being offered for patients who meet study eligibility criteria and have not previously received this testing.  

Clinical Study Identifier: TX210463

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