Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Taiho Oncology, Inc.
- Study ID
- NCT04601857
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Advanced and Metastatic Urothelial Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Futibatinib — DRUGOral
- Pembrolizumab — DRUGIV
Study Details
The purpose of the trial is to evaluate the antitumor activity and confirm the safety for the combination of Fibroblast Growth Factor Receptor (FGFR) inhibitor futibatinib and anti-programmed cell death-1 (PD-1) antibody pembrolizumab in patients with advanced or metastatic urothelial cancer who are not candidates to receive a platinum-based treatment regimens.
Key Dates
- Start date
- Jan 7, 2021
- Status verified
- Dec 2025
- Primary completion
- Mar 8, 2024
- Completion
- Sep 16, 2025
Study Design
- Enrollment
- 43 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort AParticipants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
- Experimental: Cohort BParticipants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
Primary Outcome Measure
Objective Response Rate (ORR) [ Time Frame: Up to 38 months ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | - |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
| Henry Ford Hospital | Detroit | Michigan | 48202 | - |
| Comprehensive Care Centers of Nevada | Las Vegas | Nevada | 89148 | - |
Related coverage on Hipa.ai
- Pembrolizumab + Futibatinib Trial for Urothelial Carcinoma TerminatedPembrolizumab · Dec 31, 2025 · ClinicalTrials.gov