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NCT04349280 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT04349280: Clinical Trial Phase 1 study, sponsored by GlaxoSmithKline.
NCT04349280 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04349280, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate bintrafusp alfa in participants with metastatic or locally advanced urothelial cancer. This trial provides the first evaluation of bintrafusp alfa in participants with urothelial cancer that has progressed following platinum therapy.
Primary Outcome
Confirmed overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is d
Interventions
- DRUG Bintrafusp alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-10-15 |
| Est. Completion | 2022-08-15 |
| Phase | Phase 1 |
Why NCT04349280 stopped before completion
NCT04349280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Bintrafusp alfa is the first listed.
NCT04349280 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04349280 about?
NCT04349280 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer". The purpose of this study is to evaluate bintrafusp alfa in participants with metastatic or locally advanced urothelial cancer. This trial provides the first evaluation of bintrafusp alfa in participants with urothelial cancer that has progressed following platinum therapy.
What is the current status of trial NCT04349280?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2020-10-15. Estimated completion is 2022-08-15.
What interventions are being tested in trial NCT04349280?
The interventions under investigation include: Bintrafusp alfa (DRUG).
Who is sponsoring clinical trial NCT04349280?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04349280's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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