Last updated on August 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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Institut Jules Bordet
Bruxelles, Belgium
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Rigshospitalet (Copenhagen University Hospital)
Copenhagen, Denmark
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Institut Bergonié - Centre Regional De Lutte Contre Le Cance
Bordeaux, France
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Országos Onkológiai Intézet
Budapest, Hungary
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IRCCS Istituto Nazionale dei Tumori
Milano, Italy
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IRCCS - Istituto Europeo di Oncologia
Milano, Italy
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Severance Hospital, Yonsei University Health System - Medical Oncology
Seoul, Korea
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Samsung Medical Center - Hematology-Oncology
Seoul, Korea
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Seoul National University Bundang Hospital - Hematology/Oncology
Seongnam-si, Korea
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UMCU - Vascular Medicine
Utrecht, Netherlands
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Uniwersyteckie Centrum Kliniczne im. Prof.K.Gibinskiego SUM W Katowicach
Katowice, Poland
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Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
Warszawa, Poland
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Mazowiecki Szpital Onkologiczny
Wieliszew, Poland
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MAGODENT Sp. z o.o.
Warszawa, Poland
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Dolnoslaskie Centrum Onkologii
Wroclaw, Poland
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P.A. Herzen Moscow Oncology Research Institute
Moscow, Russia
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Bashkiria State Medical University
Ufa, Russia
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Special hospital for Internal diseases, Oncomed system
Belgrade, Serbia
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Oncology Institute of Vojvodina
Sremska, Serbia
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Clinical Center of Serbia
Belgrade, Serbia
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Clinical Center Kragujevac
Kragujevac, Serbia
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Centro Integral Oncológico Clara Campal
Madrid, Spain
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Hospital Universitario 12 de Octubre
Madrid, Spain
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Akademiska sjukhuset
Uppsala, Sweden
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Ankara University Medical Faculty
Ankara, Turkey
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Akdeniz University Medical Faculty
Antalya, Turkey
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DU Natsionalnyi instytut raka MOZ
Kyiv, Ukraine
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Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4
Dnipropetrovsk, Ukraine
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Washington University School of Medicine
St. Louis, MO United States
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The West Clinic
Germantown, TN United States
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M. D. Anderson Cancer Center
Houston, TX United States
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University of Virginia Cancer Center - Emily Couric Clinical Cancer Center
Cleveland, OH United States
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Marin Cancer Care
Greenbrae, CA United States
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Norton Cancer Institute
Louisville, KY United States
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Parkview Research Center
Fort Wayne, IN United States
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