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NCT04601857 · ClinicalTrials.gov registry record · Phase 2
Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
A Phase 2 study, sponsored by Taiho Oncology.
- Terminated
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT04601857: Clinical Trial Phase 2 study, sponsored by Taiho Oncology.
NCT04601857 is a Phase 2 study that was terminated before completion, run by Taiho Oncology. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04601857, a Phase 2 study, was terminated before completion, sponsored by Taiho Oncology.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
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.
Primary Outcome
ORR was defined as the proportion of participants experiencing a best overall response of partial response (PR) or complete response (CR) according to response evaluation criteria in solid tumors, version 1.1 (RECIST 1.1) criteria based on investigator assessment. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30 percent (%) decrease in the sum of di
Interventions
- DRUG Pembrolizumab
- DRUG Futibatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2021-01-07 |
| Est. Completion | 2025-09-16 |
| Phase | Phase 2 |
Why NCT04601857 stopped before completion
NCT04601857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04601857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04601857 about?
NCT04601857 is a clinical study titled "Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma". 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...
What is the current status of trial NCT04601857?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2021-01-07. Estimated completion is 2025-09-16.
What interventions are being tested in trial NCT04601857?
The interventions under investigation include: Pembrolizumab (DRUG), Futibatinib (DRUG).
Who is sponsoring clinical trial NCT04601857?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04601857's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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