Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Public ClinicalTrials.gov record NCT06501625. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b/2, Safety Lead-in and Dose-Expansion, Open Label, Multicenter Trial Investigating 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
Study identification
- NCT ID
- NCT06501625
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Institut de Recherches Internationales Servier
- Other
- Enrollment
- 52 participants
Conditions and interventions
Interventions
- Cisplatin (for the first 8, 21-day, cycles) Drug
- Durvalumab (for the first 8, 21-day, cycles) Drug
- Durvalumab (starting from cycle 9) Drug
- Gemcitabine (for the first 8, 21-day, cycles) Drug
- Ivosidenib Drug
- Ivosidenib Recommended Combination Dose (RCD) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 15, 2024
- Primary completion
- Jul 22, 2026
- Completion
- Sep 12, 2027
- Last update posted
- May 10, 2026
2024 – 2027
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cancer and Blood Speciality Clinic - Los Alamitos | Los Alamitos | California | 90720 | Recruiting |
| Usc Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| Northwestern Medicine | Chicago | Illinois | 60611 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| Duke University | Durham | North Carolina | 27708 | Recruiting |
| Gibbs Cancer Center | Spartanburg | South Carolina | 29303 | Recruiting |
| Tennesse Oncology - Elliston Place Plaza | Nashville | Tennessee | 37203 | Recruiting |
| The University of Texas Md Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06501625, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 10, 2026 · Synced May 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06501625 live on ClinicalTrials.gov.