Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Start Date
12/16/2024
Completion Date
9/13/2027
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 Criteria
Age Range: 18 years to No maximum
Interventions
Ivosidenib
Durvalumab (for the first 8, 21-day, cycles)
Gemcitabine (for the first 8, 21-day, cycles)
Cisplatin (for the first 8, 21-day, cycles)
Durvalumab (starting from cycle 9)
Ivosidenib Recommended Combination Dose (RCD)
Conditions
Locations
Cancer and Blood Speciality Clinic - Los Alamitos
Los Alamitos, California 90720
United States
Usc Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Northwestern Medicine
Chicago, Illinois 60611
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Duke University
Durham, North Carolina 27708
United States
Gibbs Cancer Center
Spartanburg, South Carolina 29303
United States
Tennesse Oncology - Elliston Place Plaza
Nashville, Tennessee 37203
United States
The University of Texas Md Anderson Cancer Center
Houston, Texas 77030
United States
Alfred Health
Melbourne, 3004
Australia
Hospital de Amor - Barretos
Barretos, 14784400
Brazil
Oncoclinicas Mg
Belo Horizonte, 303600680
Brazil
CIONC
Curitiba, 80810050
Brazil
Instituto Dor de Pesquisa E Ensino Sp
São Paulo, 4543000
Brazil
Princess Margaret Cancer Centre
Toronto, M5G 2C4
Canada
Institut Bergonie
Bordeaux, 33076
France
Hôpital Beaujon
Clichy, 92210
France
Chu Montpellier-Hopital Saint-Eloi
Montpellier, 34295
France
Charite Universitatsmedizin
Berlin, 13353
Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Germany
Universitären Centrums Für Tumorerkrankungen (Uct) Der J.W. Goethe-Universität Frankfurt
Frankfurt, 60488
Germany
Medizinische Hochschule Hannover Oe 6810
Hanover, 30625
Germany
Universitätsklinikum Ulm
Ulm, 89081
Germany
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Japan
National Cancer Center Hospital
Chūōku, 104-0045
Japan
Kyoto University Hospital
Kyoto, 606-8507
Japan
Kanagawa Cancer Center
Yokohama, 241-8515
Japan
Cha Bundang Medical Center
Seongnam, 13496
South Korea
Seoul National University Bundang Hospital
Seongnam, 13620
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Seoul National University Hospital
Seoul, 3080
South Korea
Severance
Seoul, 3722
South Korea
Seoul St. Mary'S Hospital
Seoul, 6591
South Korea
H. Valle de Hebron
Barcelona, 8035
Spain
Hospital Clinic de Barcelona
Barcelona,
Spain
Hospital Universitario Gregorio Marañón
Madrid, 28007
Spain
H. 12 de Octubre
Madrid, 28040
Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Spain