Condition: Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation · Sponsor: Institut de Recherches Internationales Servier
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.
This description comes directly from the study's public registry record.
Institut de Recherches Internationales Servier (I.R.I.S.) Clinical Studies Department · +33 1 55 72 60 00 · scientificinformation@servier.com
Always discuss trial participation with your own doctor first.
| Cancer and Blood Speciality Clinic - Los Alamitos | Los Alamitos, California, United States | Recruiting |
| Usc Norris Comprehensive Cancer Center | Los Angeles, California, United States | Recruiting |
| Northwestern Medicine | Chicago, Illinois, United States | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York, New York, United States | Recruiting |
| Duke University | Durham, North Carolina, United States | Recruiting |
| Gibbs Cancer Center | Spartanburg, South Carolina, United States | Recruiting |
| Tennesse Oncology - Elliston Place Plaza | Nashville, Tennessee, United States | Recruiting |
| The University of Texas Md Anderson Cancer Center | Houston, Texas, United States | Recruiting |
| Alfred Health | Melbourne, Australia | Recruiting |
| Hospital de Amor - Barretos | Barretos, Brazil | Recruiting |
| Oncoclinicas Mg | Belo Horizonte, Brazil | Recruiting |
| CIONC | Curitiba, Brazil | Recruiting |
+ 26 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06501625