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NCT05921760 · ClinicalTrials.gov registry record · Phase 1
Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma
A Phase 1 study, sponsored by Servier Bio-Innovation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT05921760 is a Phase 1 study that was terminated before completion, run by Servier Bio-Innovation. The registered enrollment target is 7 participants.
The verdict
NCT05921760, a Phase 1 study, was terminated before completion, sponsored by Servier Bio-Innovation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a Phase 1/2 study evaluating the safety, tolerability, and activity of ivosidenib in combination with immunotherapy in participants with nonresectable or metastatic cholangiocarcinoma. The study includes two phases: the safety lead-in phase to determine the recommended combination dose (RCD) of ivosidenib in combination with immunotherapy and the dose expansion phase to assess the efficacy of ivosidenib in combination with immunotherapy. Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met. This study was terminated by the sponsor before the expansion phase began and therefore participants were only involved in the safety lead-in phase.
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Ivosidenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2023-10-23 |
| Est. Completion | 2024-11-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05921760
The ClinicalTrials.gov registry entry for NCT05921760 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Servier Bio-Innovation, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT05921760 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05921760 about?
NCT05921760 is a clinical study titled "Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma". This is a Phase 1/2 study evaluating the safety, tolerability, and activity of ivosidenib in combination with immunotherapy in participants with nonresectable or metastatic cholangiocarcinoma. The study includes two phases: the safety lead-in phase to determine the recommended combination dose (RCD)...
What is the current status of trial NCT05921760?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2023-10-23. Estimated completion is 2024-11-21.
What interventions are being tested in trial NCT05921760?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Ivosidenib (DRUG).
Who is sponsoring clinical trial NCT05921760?
This trial is sponsored by Servier Bio-Innovation, which has 9 total clinical trials registered on ClinicalTrials.gov.
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