NCT06501625 · Institut de Recherches Internationales Servier
Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
What this study 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.
View original scientific description
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.
Interventions
DRUG
Ivosidenib
Two 250 mg tablets, totaling 500 mg, administered orally once daily, taken continuously throughout treatment duration
DRUG
Durvalumab (for the first 8, 21-day, cycles)
1500mg intravenous (IV) infusion every 3 weeks, for a maximum of 8 (21-day) cycles
DRUG
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
DRUG
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
DRUG
Durvalumab (starting from cycle 9)
1500mg intravenous (IV) infusion every 4 weeks, starting from cycle 9. Cycles are 28 days long, starting Cycle 9.
DRUG
Ivosidenib Recommended Combination Dose (RCD)
RCD administered orally once daily, taken continuously throughout treatment duration
Primary outcome measures
Safety Lead-in Phase: Number of Dose-limiting toxicities (DLTs)
Time frame: 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)
Time frame: Through 90 days after the end of treatment (Approximately 5 years)
Expansion Phase: Objective response rate (ORR)
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Have a histopathological confirmed diagnosis consistent with locally advanced unresectable or metastatic cholangiocarcinoma.
- Have documented IDH1 gene-mutated cholangiocarcinoma based on local or central laboratory testing (R132C/L/G/H/S mutation variants tested).
- Have at least one evaluable and measurable lesion as defined by RECIST v1.1.
- Have adequate bone marrow function as evidenced by:
- Absolute neutrophil count ≥ 1,500/mm3 or 1.5 ×109/L
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100,000/mm3 or 100 × 109/L
- Have adequate hepatic function as evidenced by:
- Serum bilirubin ≤ 2.0 × the upper limit of normal (ULN); this will not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction should be resolved before randomization
- Aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤ 5.0 × ULN
- Have adequate renal function, defined as: cr
Where
- Los Alamitos, California
- Los Angeles, California
- Chicago, Illinois
- New York, New York
- Durham, North Carolina
- Spartanburg, South Carolina
- Nashville, Tennessee
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations