Actively Recruiting
Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Led by Institut de Recherches Internationales Servier · Updated on 2026-05-11
52
Participants Needed
38
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed diagnosis of locally advanced unresectable or metastatic cholangiocarcinoma
- Documented IDH1 gene-mutated cholangiocarcinoma with R132C/L/G/H/S mutation variants
- At least one measurable lesion by RECIST v1.1 criteria
- Adequate bone marrow function: neutrophils 1,500/mm3, hemoglobin 9 g/dL, platelets 100,000/mm3
- Adequate liver function: bilirubin 2.0 times upper limit of normal (ULN), AST and ALT 2.5 times ULN or 5.0 times ULN if liver metastases present
- Adequate kidney function with creatinine clearance > 60 mL/min or calculated by Cockcroft-Gault formula
You will not qualify if you...
- Prior treatment for advanced cholangiocarcinoma except up to one cycle of durvalumab plus gemcitabine/cisplatin
- Prior immune therapies including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies (except therapeutic vaccines)
- Unresolved grade 2 adverse events from previous cancer therapy (except alopecia and vitiligo)
- Grade 2 neuropathy unless approved by medical monitor
- Participation in another interventional trial within 14 days before study treatment
- Active or prior autoimmune or inflammatory diseases (e.g., inflammatory bowel disease, lupus, sarcoidosis) unless inactive for at least 5 years and approved
- Heart rate-corrected QT interval 450 msec or conditions increasing risk of QT prolongation
- Active infections including hepatitis B with detectable virus, hepatitis C RNA positive, tuberculosis, or HIV-positive status
- Irreversible toxicities that may be worsened by ivosidenib without medical monitor approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
Cancer and Blood Speciality Clinic - Los Alamitos
Los Alamitos, California, United States, 90720
Actively Recruiting
2
Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Northwestern Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
5
Duke University
Durham, North Carolina, United States, 27708
Actively Recruiting
6
Gibbs Cancer Center
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
7
Tennesse Oncology - Elliston Place Plaza
Nashville, Tennessee, United States, 37203
Actively Recruiting
8
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
9
Alfred Health
Melbourne, Australia, 3004
Actively Recruiting
10
Hospital de Amor - Barretos
Barretos, Brazil, 14784400
Actively Recruiting
11
Oncoclinicas Mg
Belo Horizonte, Brazil, 303600680
Actively Recruiting
12
CIONC
Curitiba, Brazil, 80810050
Actively Recruiting
13
Instituto Dor de Pesquisa E Ensino Sp
São Paulo, Brazil, 4543000
Actively Recruiting
14
Princess Margaret Cancer Centre
Toronto, Canada, M5G 2C4
Actively Recruiting
15
Institut Bergonie
Bordeaux, France, 33076
Actively Recruiting
16
Hôpital Beaujon
Clichy, France, 92210
Actively Recruiting
17
Chu Montpellier-Hopital Saint-Eloi
Montpellier, France, 34295
Actively Recruiting
18
Charite Universitatsmedizin
Berlin, Germany, 13353
Actively Recruiting
19
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
20
Universitären Centrums Für Tumorerkrankungen (Uct) Der J.W. Goethe-Universität Frankfurt
Frankfurt, Germany, 60488
Actively Recruiting
21
Medizinische Hochschule Hannover Oe 6810
Hanover, Germany, 30625
Actively Recruiting
22
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
23
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
24
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Actively Recruiting
25
Kyoto University Hospital
Kyoto, Japan, 606-8507
Actively Recruiting
26
Kanagawa Cancer Center
Yokohama, Japan, 241-8515
Actively Recruiting
27
Cha Bundang Medical Center
Seongnam, South Korea, 13496
Actively Recruiting
28
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
29
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
30
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
31
Seoul National University Hospital
Seoul, South Korea, 3080
Actively Recruiting
32
Severance
Seoul, South Korea, 3722
Actively Recruiting
33
Seoul St. Mary'S Hospital
Seoul, South Korea, 6591
Actively Recruiting
34
H. Valle de Hebron
Barcelona, Spain, 8035
Actively Recruiting
35
Hospital Clinic de Barcelona
Barcelona, Spain
Actively Recruiting
36
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
37
H. 12 de Octubre
Madrid, Spain, 28040
Actively Recruiting
38
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
Research Team
I
Institut de Recherches Internationales Servier (I.R.I.S.) Clinical Studies Department
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here