A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined With Pembrolizumab in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Who Have Progressed Following Platinum-based Chemotherapy


Condition: Locally Advanced or Metastatic Urothelial Cell Carcinoma, Urinary Bladder Disease, Urological Diseases

Intervention:

  • Drug: B-701
  • Drug: Pembrolizumab

Purpose: This is a Phase 1b/2 multi-center, open-label study to establish the initial safety and to determine a recommended Phase 2 dose of B-701 in combination with pembrolizumab, and to determine safety, tolerability and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with locally advanced or metastatic UCC, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03123055

Sponsor: Rainier Therapeutics

Primary Outcome Measures:

  • Measure: Initial safety and determination of recommended Phase 2 dose according to dose-limiting Toxicity
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Safety and tolerability of B-701 (vofatamab) plus pembrolizumab
  • Time Frame: 2.5 years
  • Safety Issue:
  • Measure: Efficacy of B-701 (vofatamab) plus pembrolizumab measured by ORR
  • Time Frame: 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Assessment of changes in biomarkers induced by B-701 (vofatamab)
  • Time Frame: 2.5 years
  • Safety Issue:
  • Measure: Efficacy of B-701 (vofatamab) in combination with pembrolizumab as measured by DOR
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Efficacy of B-701 (vofatamab) in combination with pembrolizumab as measured by DCR
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Efficacy of B-701 (vofatamab) in combination with pembrolizumab as measured by PFS
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Efficacy of B-701 (vofatamab) in combination with pembrolizumab as measured by OS
  • Time Frame: 2.5 years
  • Safety Issue:
  • Measure: Change in subject reported quality of life
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 74

Study Start Date: April 20, 2017

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Key Inclusion Criteria:

  1. Have locally advanced (on TNM staging: T4b and any N, or any T and N2-3) or metastatic transitional cell carcinoma of the urothelium, including of the urinary bladder, urethra, ureter, and/or renal pelvis. The diagnosis must be histologically or cytologically confirmed.
  2. Have progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  3. Have available archival tumor or be willing to undergo diagnostic biopsy at screening. Sample must be of suitable quality and quantity to satisfy group assignment and biomarker endpoints.
  4. Have measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.

Key Exclusion Criteria:

  1. Participants with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on the Screening chest CT scan.
  2. Prior therapy with an anti-programmed cell death 1 (PD-1) or anti-PD-Ligand 1 agent, or with an agent directed to another co-inhibitory T-cell receptor or FGFR inhibitor.
  3. Patients with autoimmune disease or medical conditions that required systemic corticosteroids (> 10 mg/day prednisone or its equivalent) or other immunosuppressive medications or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment. Note: Replacement therapy (e.g. physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  4. Primary central nervous system (CNS) malignancy or CNS metastases.
  5. History of clinically significant coagulation or platelet disorder in the past 12 months.

Contact:

  • Rainier Therapeutics
  • 925-413-6140

Locations:

  • Research Site
  • Greenbrae California 94904 United States
  • Research Site
  • Fort Wayne Indiana 46845 United States
  • Research Site
  • Louisville Kentucky 40202 United States
  • Washington University School of Medicine
  • Saint Louis Missouri 63110 United States
  • Research Site
  • Cleveland Ohio 44195 United States
  • Research Site
  • Philadelphia Pennsylvania 19107 United States
  • Research Site
  • Germantown Tennessee 38138 United States
  • Research Site
  • Houston Texas 77030 United States
  • Research Site
  • Brussel 1000 Belgium
  • Research Site
  • Leuven 3000 Belgium
  • Research Team
  • Yvoir 5530 Belgium
  • Research Team
  • Copenhagen 2100 Denmark
  • Research Site
  • Bordeaux 33076 France
  • Research Site
  • Dijon 21000 France
  • Research Site
  • Dresden 01307 Germany
  • Research Site
  • Frankfurt 60488 Germany
  • Research Site
  • Heidelberg 69120 Germany
  • Research Site
  • Kassel 34125 Germany
  • Research Site
  • Munich 81377 Germany
  • Research Site
  • Münster 48149 Germany
  • Research Site
  • Budapest 1122 Hungary
  • Research Site
  • Milano 20133 Italy
  • Research Site
  • Milano 20141 Italy
  • Research Site
  • Gwangju 61469 Korea, Republic of
  • Research Site
  • Seongnam-si 13620 Korea, Republic of
  • Research Site
  • Seoul 03722 Korea, Republic of
  • Research Site
  • Seoul 06351 Korea, Republic of
  • Research Site
  • Chisinau 2025 Moldova, Republic of
  • Research Site
  • Utrecht 3584 CX Netherlands
  • Research Site
  • Katowice 40-514 Poland
  • Research Site
  • Warsaw 02-567 Poland
  • Research Site
  • Warsaw 02-781 Poland
  • Research Site
  • Wieliszew 05-135 Poland
  • Research Site
  • Wroclaw 53-413 Poland
  • Research Site
  • Moscow 125284 Russian Federation
  • Research Site
  • Saint Petersburg 197758 Russian Federation
  • Research Team
  • Ufa 450000 Russian Federation
  • Research Site
  • Belgrade 11000 Serbia
  • Research Site
  • Belgrade 11070 Serbia
  • Research Site
  • Kragujevac 34000 Serbia
  • Research Site
  • Niš 18000 Serbia
  • Research Site
  • Sremska Kamenica 21204 Serbia
  • Research Site
  • Madrid CA 28050 Spain
  • Research Site
  • Barcelona 08035 Spain
  • Research Site
  • Barcelona 08036 Spain
  • Research Site
  • Madrid 28034 Spain
  • Research Site
  • Madrid 28041 Spain
  • Research Site
  • Uppsala 75185 Sweden
  • Research Site
  • Ankara 06100 Turkey
  • Research Site
  • Antalya 07059 Turkey
  • Research Site
  • Dnipropetrovs'k 49102 Ukraine
  • Research Site
  • Kiew 03022 Ukraine

View trial on ClinicalTrials.gov


E-Newsletters

Newsletter subscription

Free Daily and Weekly newsletters offered by content of interest

The fields of GU Oncology and Urology are rapidly advancing. Sign up today for articles, videos, conference highlights and abstracts from peer-review publications by disease and condition delivered to your inbox and read on the go.

Subscribe