Clinical trial · Interventional
Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
A Phase 2 Study Evaluating Futibatinib (TAS 120) Plus Pembrolizumab in the Treatment of Advanced or Metastatic Urothelial Carcinoma
NCT04601857CI-TRIAL-00099895terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decided to discontinue the study due to strategic considerations and not due to any safety-related concerns.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced and Metastatic Urothelial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Futibatinib | Drug | Futibatinib | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Participants 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.
- interventionNames
- Drug: Futibatinib
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Participants 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.
- interventionNames
- Drug: Futibatinib
- Drug: Pembrolizumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Willing and able to provide written informed consent for the trial. 2. Age ≥ 18 years of age 3. Histologically confirmed advanced or metastatic urothelial carcinoma who have not received systemic treatment for advanced metastatic disease. 1. Cohort A: must have an FGFR3 mutation or FGFR1-4 fusion/rearrangement. 2. Cohort B: all other patients with UC (including patients with other FGFR or non-FGFR genetic aberrations and patients with wild-type \[non-mutated\] tumors) 4. Unfit for or intolerant to standard platinum-based chemotherapy. 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1. 6. Adequate organ function. 7. Have a measurable disease per RECIST 1.1 Exclusion Criteria: 1. Have received prior therapy with anti-PD-1, anti-PD-L1/L2 agent or FGFR inhibitor. 2. History and/or current evidence of any of the following disorders: 1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator. 2. Ectopic mineralization/calcification considered clinically significant in the opinion of the Investigator. 3. Retinal or corneal disorder considered clinically significant in the opinion of the Investigator. 3. Has received a live vaccine within 30 days prior to the first dose of study drug. 4. Have an active autoimmune disease that has required systemic treatment in the past 2 years. 5. Have a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis. 6. Have had an allogenic tissue/ organ transplant. 7. Has known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C Antibody or RNA. 8. Have known active central nervous system metastases and/or carcinomatous meningitis. 9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. 10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
References
Publications (0)
Data not yet available
No reference posted for this study.