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Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
NCT06501625 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06501625
The ClinicalTrials.gov registry entry for NCT06501625 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institut de Recherches Internationales Servier, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06501625 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06501625?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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