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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 is a Phase 2 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 309 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04066491
The ClinicalTrials.gov registry entry for NCT04066491 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04066491 reports 0 study locations.
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.
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