Last updated on November 2019

Fierce-21: A Phase 1/2(b) Study of Vofatamab in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma

Brief description of study

The FIERCE-21 study is a Phase 1/2(b) study to evaluate the effectiveness and safety of Vofatamab  alone (monotherapy) and vofatamab plus docetaxel versus placebo plus docetaxel in the treatment of subjects with Stage IV, locally advanced or metastatic FGFR mutation positive UCC who have previously been treated for their bladder cancer which gotten worse or has come back after at least one prior line of chemotherapy and immunotherapy.

This study is divided into 3 phases with following treatments: Vofatamab plus docetaxel in Phase 1b (closed), comparison of vofatamab plus docetaxel versus vofatamab alone in Phase 2, vofatamab alone (Monotherapy Expansion Phase) and vofatamab plus docetaxel versus placebo plus docetaxel (Randomized Phase, blinded) in Phase 2b.  Subjects enrolling in Phase 2 and 2b 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: TX208460

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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