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NCT03833661 · ClinicalTrials.gov registry record · Phase 2
M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
A Phase 2 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 159
- Enrollment target
NCT03833661: Completed Phase 2 study, sponsored by EMD Serono Research & Development Institute.
NCT03833661 is a Phase 2 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 159 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03833661, a Phase 2 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 159 participants
- Enrollment target
Study Summary
The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
Primary Outcome
Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and bef
Interventions
- DRUG M7824
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2019-03-26 |
| Est. Completion | 2022-09-30 |
| Phase | Phase 2 |
What the finished NCT03833661 record still lists
NCT03833661 is an interventional study that assigns participants to a tested intervention. The registered 159 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 (20% higher).
The record links to 0 conditions, and to 1 intervention - of which M7824 is the first listed.
NCT03833661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03833661 about?
NCT03833661 is a clinical study titled "M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)". The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
What is the current status of trial NCT03833661?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2019-03-26. Estimated completion is 2022-09-30.
What interventions are being tested in trial NCT03833661?
The interventions under investigation include: M7824 (DRUG).
Who is sponsoring clinical trial NCT03833661?
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 NCT03833661's enrollment target sits among peer trials
159 442nd of 2000 higher than 1,558 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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