Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Condition(s) studied
Investigational drug(s) / intervention(s)
Ivosidenib: Two 250 mg tablets, totaling 500 mg, administered orally once daily, taken continuously throughout treatment duration
Durvalumab (for the first 8, 21-day, cycles): 1500mg intravenous (IV) infusion every 3 weeks, for a maximum of 8 (21-day) cycles
Gemcitabine (for the first 8, 21-day, cycles): 1000 mg/m2 IV infusion on days 1 and 8 of every 21-day cycle, for a maximum of 8 cycles
Cisplatin (for the first 8, 21-day, cycles): 25 mg/m\^2 IV infusion on days 1 and 8 of every 21-day cycle, for a maximum of 8 cycles
Durvalumab (starting from cycle 9): 1500mg intravenous (IV) infusion every 4 weeks, starting from cycle 9. Cycles are 28 days long, starting Cycle 9.
Ivosidenib Recommended Combination Dose (RCD): RCD administered orally once daily, taken continuously throughout treatment duration
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.
Eligibility
Primary outcome measure(s)
- Safety Lead-in Phase: Number of Dose-limiting toxicities (DLTs) — Through Cycle 1 (Cycle 1 is 21 days)
- Safety Lead-in Phase: Number of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) — Through 90 days after the end of treatment (Approximately 5 years)
- Expansion Phase: Objective response rate (ORR) — Through the end of the study (Approximately 5 years)
Confirmed complete response (CR) or confirmed partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Trial sites (38)
| Facility | City | Region | Status |
|---|---|---|---|
| Cancer and Blood Speciality Clinic - Los Alamitos | Los Alamitos | California | Recruiting |
| Usc Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| Northwestern Medicine | Chicago | Illinois | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Duke University | Durham | North Carolina | Recruiting |
| Gibbs Cancer Center | Spartanburg | South Carolina | Recruiting |
| Tennesse Oncology - Elliston Place Plaza | Nashville | Tennessee | Recruiting |
| The University of Texas Md Anderson Cancer Center | Houston | Texas | Recruiting |
| Alfred Health | Melbourne | Australia | Recruiting |
| Hospital de Amor - Barretos | Barretos | Brazil | Recruiting |
| Oncoclinicas Mg | Belo Horizonte | Brazil | Recruiting |
| CIONC | Curitiba | Brazil | Recruiting |
| Instituto Dor de Pesquisa E Ensino Sp | São Paulo | Brazil | Recruiting |
| Princess Margaret Cancer Centre | Toronto | Canada | Recruiting |
| Institut Bergonie | Bordeaux | France | Recruiting |
| Hôpital Beaujon | Clichy | France | Recruiting |
| Chu Montpellier-Hopital Saint-Eloi | Montpellier | France | Recruiting |
| Charite Universitatsmedizin | Berlin | Germany | Recruiting |
| Universitätsklinikum Düsseldorf | Düsseldorf | Germany | Recruiting |
| Universitären Centrums Für Tumorerkrankungen (Uct) Der J.W. Goethe-Universität Frankfurt | Frankfurt | Germany | Recruiting |
| Medizinische Hochschule Hannover Oe 6810 | Hanover | Germany | Recruiting |
| Universitätsklinikum Ulm | Ulm | Germany | Recruiting |
| National Cancer Center Hospital East | Kashiwa | Chiba | Recruiting |
| National Cancer Center Hospital | Chūōku | Japan | Recruiting |
| Kyoto University Hospital | Kyoto | Japan | Recruiting |
| Kanagawa Cancer Center | Yokohama | Japan | Recruiting |
| Cha Bundang Medical Center | Seongnam | South Korea | Recruiting |
| Seoul National University Bundang Hospital | Seongnam | South Korea | Recruiting |
| Asan Medical Center | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Severance | Seoul | South Korea | Recruiting |
| Seoul St. Mary'S Hospital | Seoul | South Korea | Recruiting |
| H. Valle de Hebron | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital Universitario Gregorio Marañón | Madrid | Spain | Recruiting |
| H. 12 de Octubre | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Recruiting |
More Institut de Recherches Internationales Servier trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06501625 on ClinicalTrials.gov ↗ ← All trials in France