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NCT06501625 · ClinicalTrials.gov registry record · Phase 1
Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
A Phase 1 study of Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation, sponsored by Institut de Recherches Internationales Servier.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 20
- Study locations
NCT06501625: Recruiting Phase 1 study of Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation, sponsored by Institut de Recherches Internationales Servier.
NCT06501625 is a Phase 1 study of Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation that is actively recruiting participants, run by Institut de Recherches Internationales Servier. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06501625, a Phase 1 study of Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation, is actively recruiting participants, sponsored by Institut de Recherches Internationales Servier.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to investigate the safety, tolerability and preliminary activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin as first-line therapy in participants with locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation. The study will begin with a safety lead-in phase (Phase 1b study) to determine the recommended combination dose (RDC) and then will transition to an expansion phase (Phase 2 study) to assess the clinical activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin at the RCD. During the treatment period participants will have study visits on days 1, 8, and 15 of Cycle 1, on days 1 and 8 of Cycle 2 to 8, and on day 1 of each additional cycle. Cycles 1 through 8 are 21 day cycles, and each following cycle is 28 days. Approximately 30 days and 90 days after treatment has ended, safety follow-up visits will occur and then participants will be followed for survival every 3 months. Study visits may include blood tests, ECG, vital signs, and a physical examination.
Conditions Studied
Interventions
- DRUG Ivosidenib
- DRUG Durvalumab (for the first 8, 21-day, cycles)
- DRUG Gemcitabine (for the first 8, 21-day, cycles)
- DRUG Cisplatin (for the first 8, 21-day, cycles)
- DRUG Durvalumab (starting from cycle 9)
Study Locations (20)
Other
- Alfred Health - Melbourne
- Hospital de Amor - Barretos - Barretos
- Oncoclinicas Mg - Belo Horizonte
- CIONC - Curitiba
- Instituto Dor de Pesquisa E Ensino Sp - São Paulo
- Princess Margaret Cancer Centre - Toronto
- Institut Bergonie - Bordeaux
- Hôpital Beaujon - Clichy
- Chu Montpellier-Hopital Saint-Eloi - Montpellier
- Charite Universitatsmedizin - Berlin
- Universitätsklinikum Düsseldorf - Düsseldorf
- Universitären Centrums Für Tumorerkrankungen (Uct) Der J.W. Goethe-Universität Frankfurt - Frankfurt
- Medizinische Hochschule Hannover Oe 6810 - Hanover
California
- Usc Norris Comprehensive Cancer Center - Los Angeles
Illinois
- Northwestern Medicine - Chicago
New York
- Memorial Sloan Kettering Cancer Center - New York
North Carolina
- Duke University - Durham
South Carolina
- Gibbs Cancer Center - Spartanburg
Tennessee
- Tennesse Oncology - Elliston Place Plaza - Nashville
Texas
- The University of Texas Md Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2024-12-16 |
| Est. Completion | 2027-09-13 |
| Phase | Phase 1 |
What NCT06501625 shows while recruiting
NCT06501625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation appearing as the primary indexed condition, and to 5 interventions - of which Ivosidenib is the first listed.
NCT06501625 names 20 study sites across 8 states, led by Other, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT06501625 about?
NCT06501625 is a clinical study titled "Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation". The objective of this study is to investigate the safety, tolerability and preliminary activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin as first-line therapy in participants with locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation. The...
What is the current status of trial NCT06501625?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2024-12-16. Estimated completion is 2027-09-13.
What conditions does trial NCT06501625 study?
This clinical trial studies the following conditions: Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation.
What interventions are being tested in trial NCT06501625?
The interventions under investigation include: Ivosidenib (DRUG), Durvalumab (for the first 8, 21-day, cycles) (DRUG), Gemcitabine (for the first 8, 21-day, cycles) (DRUG), Cisplatin (for the first 8, 21-day, cycles) (DRUG), Durvalumab (starting from cycle 9) (DRUG).
Who is sponsoring clinical trial NCT06501625?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06501625 being conducted?
This trial has 20 study locations across California, Illinois, New York, North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06501625's enrollment target sits among peer trials
52 957th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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