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NCT04057365 · ClinicalTrials.gov registry record · Phase 2
Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC)
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT04057365: Clinical Trial Phase 2 study, sponsored by Massachusetts General Hospital.
NCT04057365 is a Phase 2 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04057365, a Phase 2 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This research is studying the effect of the combination of how two study drugs (Nivolumab and DKN-01) works in people with advanced biliary tract cancer.
Primary Outcome
Overall response is evaluated using Response Evaluation Criteria in Solid Tumors criteria (RECIST 1.1). A participant is considered to have responded if they achieve either of the following outcomes: * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm * Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum di
Interventions
- DRUG Nivolumab
- DRUG DKN-01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-10-07 |
| Est. Completion | 2022-09-25 |
| Phase | Phase 2 |
Why NCT04057365 stopped before completion
NCT04057365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT04057365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04057365 about?
NCT04057365 is a clinical study titled "Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC)". This research is studying the effect of the combination of how two study drugs (Nivolumab and DKN-01) works in people with advanced biliary tract cancer.
What is the current status of trial NCT04057365?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2019-10-07. Estimated completion is 2022-09-25.
What interventions are being tested in trial NCT04057365?
The interventions under investigation include: Nivolumab (DRUG), DKN-01 (DRUG).
Who is sponsoring clinical trial NCT04057365?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04057365's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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