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NCT04066491 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
A Phase 2 study, sponsored by EMD Serono Research & Development Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 309
- Enrollment target
NCT04066491: Clinical Trial Phase 2 study, sponsored by EMD Serono Research & Development Institute.
NCT04066491 is a Phase 2 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 309 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (132% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04066491, a Phase 2 study, was terminated before completion, sponsored by EMD Serono Research & Development Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 309 participants
- Enrollment target
Study Summary
Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin.
Primary Outcome
A DLT is a toxicity related to the study intervention that meets the following criteria as evaluated in the open-label, safety run-in: Grade 3 or 4 Immune-related adverse event (irAE) that needs permanent discontinuation of M7824 treatment; a malignant skin lesion induced by M7824 that is local and can be resected with a negative resection margin is not a DLT; Grade 3 or 4 nonhematologic toxicity other than irAE, A life threatening hematological toxicity (unless clearly attributable to chemother
Interventions
- DRUG Placebo
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG M7824
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2019-09-20 |
| Est. Completion | 2022-11-10 |
| Phase | Phase 2 |
Why NCT04066491 stopped before completion
NCT04066491 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (132% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04066491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04066491 about?
NCT04066491 is a clinical study titled "Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC". Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival...
What is the current status of trial NCT04066491?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 309 participants. The study started on 2019-09-20. Estimated completion is 2022-11-10.
What interventions are being tested in trial NCT04066491?
The interventions under investigation include: Placebo (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), M7824 (DRUG).
Who is sponsoring clinical trial NCT04066491?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04066491's enrollment target sits among peer trials
309 163rd of 2000 higher than 1,838 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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