Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 MutationPhase 1/2NCT06501625
Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
A Phase 1/2 study testing Ivosidenib, Durvalumab (for the first 8, 21-day, cycles) and Gemcitabine (for the first 8, 21-day, cycles) in people with Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation, run by Institut de Recherches Internationales Servier at 38 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
- What is being tested?
- Ivosidenib, Durvalumab (for the first 8, 21-day, cycles) and Gemcitabine (for the first 8, 21-day, cycles)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 38 sitesin 9 countries
- Study dates
- 16 Dec 2024to 13 Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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: creatinine clearance > 60 mL/min per 24 hour urine or as calculated on the Cockcroft-Gault formula (using actual body weight):
- Creatine CL (mL/min)= (140 - Age) × (weight in kg) × (0.85 if female)/72 × serum creatinine (mg/dL)
Who cannot join
- Received treatment for locally advanced, unresectable or metastatic disease with the following exceptions:
- Treatment with up to one cycle of durvalumab plus gemcitabine/cisplatin treatment is permitted before study participation. Note: For the Safety Lead-In Phase, participants who received one prior cycle of durvalumab plus gemcitabine/cisplatin and required dose modifications for treatment-related toxicity are excluded.
- Patients who developed recurrent disease > 6 months after surgery with curative intent, and, if given, > 6 months after the completion of adjuvant (chemotherapy and/or radiation).
- Prior exposure to immune-mediated therapy, including, but not limited to, anti-PD-1or other anti-PD-L1, and anti-PD-L2, anti-CTLA-4 antibodies, excluding therapeutic anticancer vaccines.
- Unresolved Grade ≥2 adverse events from a previous anticancer therapy, with the exception of alopecia and vitiligo and the laboratory values listed in the inclusion criteria.
- Patients with Grade ≥2 neuropathy to be evaluated on a case-by-case basis after consultation with the medical monitor
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- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with ivosidenib may be included only after consultation with the medical monitor
- Participation in another interventional study at the same time or within 14 days prior to the first study medication (triple combination treatment) administration. For patients having participated to another prior interventional study, the first dose of ivosidenib should occur after a period greater than or equal to 5 half-lives or 28 days, whichever is shorter of the last dose of the prior investigational product.
- Active or prior documented autoimmune or inflammatory disorders including:
- inflammatory bowel disease (e.g., colitis or Crohn's disease)
- diverticulitis (with the exception of diverticulosis)
- systemic lupus erythematosus
- Sarcoidosis syndrome
- Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.)
- Note: in cases with no active disease for ≥ 5 years, patients may be considered for inclusion if approved by the Medical Monitor. Participants with the following conditions are eligible for the study:
- chronic skin condition that does not require systemic therapy
- vitiligo
- alopecia
- hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement therapy
- unmedicated celiac disease that is controlled by diet
- Have heart rate-corrected QT interval using Fridericia's formula (QTcF) of ≥ 450 msec or with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome/sudden death, polymorphic ventricular arrhythmia). The Sponsor should review participants with bundle branch block and prolonged QTcF for potential inclusion.
- Have an active infection, including:
- Hepatitis B (clinical evaluation includes: presence of hepatitis B surface antigen [HBsAg] and/or anti-HBcAb with detectable hepatitis B virus [HBV] DNA ≥ 10 IU/mL)
- Hepatitis C
- Tuberculosis (clinical evaluation includes: clinical history, physical examination and/or radiographic findings, and tuberculosis testing as per local practice)
- Human immunodeficiency virus (clinical evaluation includes: positive HIV 1/2 antibodies) Note: Patients with a resolved or past HBV infection (i.e., presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) do not need to be excluded from the study. Patients positive for hepatitis C (HCV) antibody are eligible only if the polymerase chain reaction is negative for HCV RNA.
Trial locations and contacts
38 sites in 9 countries.
38 sites in 9 countries
United States8 sites
Northwestern Medicine
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27708
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030
Cancer and Blood Speciality Clinic - Los Alamitos
Los Alamitos, California, 90720
Usc Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Tennesse Oncology - Elliston Place Plaza
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Gibbs Cancer Center
Spartanburg, South Carolina, 29303
South Korea7 sites
Cha Bundang Medical Center
Seongnam, 13496
Seoul National University Bundang Hospital
Seongnam, 13620
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Seoul National University Hospital
Seoul, 3080
Severance
Seoul, 3722
Seoul St. Mary'S Hospital
Seoul, 6591
Germany5 sites
Charite Universitatsmedizin
Berlin, 13353
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Universitären Centrums Für Tumorerkrankungen (Uct) Der J.W. Goethe-Universität Frankfurt
Frankfurt, 60488
Medizinische Hochschule Hannover Oe 6810
Hanover, 30625
Universitätsklinikum Ulm
Ulm, 89081
Spain5 sites
H. Valle de Hebron
Barcelona, 8035
Hospital Clinic de Barcelona
Barcelona
Hospital Universitario Gregorio Marañón
Madrid, 28007
H. 12 de Octubre
Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Brazil4 sites
Hospital de Amor - Barretos
Barretos, 14784400
Oncoclinicas Mg
Belo Horizonte, 303600680
CIONC
Curitiba, 80810050
Instituto Dor de Pesquisa E Ensino Sp
São Paulo, 4543000
Japan4 sites
National Cancer Center Hospital
Chūōku, 104-0045
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Kyoto University Hospital
Kyoto, 606-8507
Kanagawa Cancer Center
Yokohama, 241-8515
France3 sites
Institut Bergonie
Bordeaux, 33076
Hôpital Beaujon
Clichy, 92210
Chu Montpellier-Hopital Saint-Eloi
Montpellier, 34295
About this study
Official title: A Phase 1b/2, Safety Lead-in and Dose-Expansion, Open Label, Multicenter Trial Investigating 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 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.
- Being tested
- 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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvosidenibDrug
Two 250 mg tablets, totaling 500 mg, administered orally once daily, taken continuously throughout treatment duration
Durvalumab (for the first 8, 21-day, cycles)Drug
1500mg intravenous (IV) infusion every 3 weeks, for a maximum of 8 (21-day) cycles
Gemcitabine (for the first 8, 21-day, cycles)Drug
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)Drug
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)Drug
1500mg intravenous (IV) infusion every 4 weeks, starting from cycle 9. Cycles are 28 days long, starting Cycle 9.
Ivosidenib Recommended Combination Dose (RCD)Drug
RCD administered orally once daily, taken continuously throughout treatment duration
| Study group | Role | What they receive |
|---|---|---|
| Safety Lead-In Phase | Experimental | Not described Receives: Drug: Ivosidenib; Drug: Durvalumab (for the first 8, 21-day, cycles); Drug: Gemcitabine (for the first 8, 21-day, cycles); Drug: Cisplatin (for the first 8, 21-day, cycles); Drug: Durvalumab (starting from cycle 9) |
| Expansion Phase | Experimental | Not described Receives: Drug: Durvalumab (for the first 8, 21-day, cycles); Drug: Gemcitabine (for the first 8, 21-day, cycles); Drug: Cisplatin (for the first 8, 21-day, cycles); Drug: Durvalumab (starting from cycle 9); Drug: Ivosidenib Recommended Combination Dose (RCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Lead-in Phase: Number of Dose-limiting toxicities (DLTs)
Measured: 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)
Measured: Through 90 days after the end of treatment (Approximately 5 years)
Expansion Phase: Objective response rate (ORR)
Confirmed complete response (CR) or confirmed partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Through the end of the study (Approximately 5 years)
Secondary outcomes (22)
Safety Lead-in Phase: Ivosidenib Area under the concentration-versus-time curve (AUC) from time 0 to time of last measurable concentration (AUC0-t)
Measured: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Ivosidenib AUC over 1 dosing interval at steady state (AUCtau,ss)
Measured: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Ivosidenib time to maximum concentration (Tmax)
Measured: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Ivosidenib maximum concentration (Cmax)
Measured: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Ivosidenib trough concentration (Ctrough)
Measured: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Ivosidenib apparent volume of distribution (Vd/F)
Measured: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Ivosidenib apparent clearance (CL/F)
Measured: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Plasma 2-hydroxygluturate (2-HG) concentrations
Measured: Through the end of treatment (Approximately 5 years)
Expansion Phase: Number of AEs, AESIs, and SAEs
Measured: Through 90 days after the end of treatment (Approximately 5 years)
Expansion Phase: Overall survival (OS)
Measured: Through the end of the study (Approximately 5 years)
Expansion Phase: Duration of response (DOR)
Measured: Through the end of the study (Approximately 5 years)
Expansion Phase: Progression-free survival (PFS)
Measured: Through the end of the study (Approximately 5 years)
Expansion Phase: Disease control
Confirmed CR, confirmed PR, or stable disease [SD]
Measured: Through the end of the study (Approximately 5 years)
Expansion Phase: Time to response (TTR)
Measured: Through the end of the study (Approximately 5 years)
Expansion Phase: Ivosidenib Area under the concentration-versus-time curve (AUC) from time 0 to time of last measurable concentration (AUC0-t)
Measured: Through the end of treatment (Approximately 5 years)
Expansion Phase: Ivosidenib AUC over 1 dosing interval at steady state (AUCtau,ss)
Measured: Through the end of treatment (Approximately 5 years)
Expansion Phase: Ivosidenib time to maximum concentration (Tmax)
Measured: Through the end of treatment (Approximately 5 years)
Expansion Phase: Ivosidenib maximum concentration (Cmax)
Measured: Through the end of treatment (Approximately 5 years)
Expansion Phase: Ivosidenib trough concentration (Ctrough)
Measured: Through the end of treatment (Approximately 5 years)
Expansion Phase: Ivosidenib apparent volume of distribution (Vd/F)
Measured: Through the end of treatment (Approximately 5 years)
Expansion Phase: Ivosidenib apparent clearance (CL/F)
Measured: Through the end of treatment (Approximately 5 years)
Expansion Phase: Plasma 2-hydroxygluturate (2-HG) concentrations
Measured: Through the end of treatment (Approximately 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start16 Dec 2024
- Primary completion13 Sep 2027 (estimated)
- Study completion13 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501625
- Sponsor's protocol ID
- S095031-210
- Other IDs
- 2024-514261-19-00
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * Used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Safety Lead-in and Dose-Expansion, Open Label, Multicenter Trial Investigating 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
- ClinicalTrials.gov ID
- NCT06501625
- Acronym / sponsor ID
- S095031-210
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 13 Sep 2027 (estimated)
- Study completion
- 13 Sep 2027 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety Lead-In Phase | Experimental | Drug: Ivosidenib, Drug: Durvalumab (for the first 8, 21-day, cycles), Drug: Gemcitabine (for the first 8, 21-day, cycles), Drug: Cisplatin (for the first 8, 21-day, cycles), Drug: Durvalumab (starting from cycle 9) |
| Expansion Phase | Experimental | Drug: Durvalumab (for the first 8, 21-day, cycles), Drug: Gemcitabine (for the first 8, 21-day, cycles), Drug: Cisplatin (for the first 8, 21-day, cycles), Drug: Durvalumab (starting from cycle 9), Drug: Ivosidenib Recommended Combination Dose (RCD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (26 listed)
- Received treatment for locally advanced, unresectable or metastatic disease with the following exceptions:
- Treatment with up to one cycle of durvalumab plus gemcitabine/cisplatin treatment is permitted before study participation. Note: For the Safety Lead-In Phase, participants who received one prior cycle of durvalumab plus gemcitabine/cisplatin and required dose modifications for treatment-related toxicity are excluded.
- Patients who developed recurrent disease > 6 months after surgery with curative intent, and, if given, > 6 months after the completion of adjuvant (chemotherapy and/or radiation).
- Prior exposure to immune-mediated therapy, including, but not limited to, anti-PD-1or other anti-PD-L1, and anti-PD-L2, anti-CTLA-4 antibodies, excluding therapeutic anticancer vaccines.
- Unresolved Grade ≥2 adverse events from a previous anticancer therapy, with the exception of alopecia and vitiligo and the laboratory values listed in the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvosidenibTwo 250 mg tablets, totaling 500 mg, administered orally once daily, taken continuously throughout treatment duration | Drug | Safety Lead-In Phase |
| Durvalumab (for the first 8, 21-day, cycles)1500mg intravenous (IV) infusion every 3 weeks, for a maximum of 8 (21-day) cycles | Drug | Expansion Phase, Safety Lead-In Phase |
| 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 | Expansion Phase, Safety Lead-In Phase |
| 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 | Expansion Phase, Safety Lead-In Phase |
| 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 | Expansion Phase, Safety Lead-In Phase |
| Ivosidenib Recommended Combination Dose (RCD)RCD administered orally once daily, taken continuously throughout treatment duration | Drug | Expansion Phase |
Primary outcome
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
22 secondary outcomes
Safety Lead-in Phase: Ivosidenib Area under the concentration-versus-time curve (AUC) from time 0 to time of last measurable concentration (AUC0-t)
Time frame: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Ivosidenib AUC over 1 dosing interval at steady state (AUCtau,ss)
Time frame: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Ivosidenib time to maximum concentration (Tmax)
Time frame: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Ivosidenib maximum concentration (Cmax)
Time frame: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Ivosidenib trough concentration (Ctrough)
Time frame: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Ivosidenib apparent volume of distribution (Vd/F)
Time frame: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Ivosidenib apparent clearance (CL/F)
Time frame: Through the end of treatment (Approximately 5 years)
Safety Lead-in Phase: Plasma 2-hydroxygluturate (2-HG) concentrations
Time frame: Through the end of treatment (Approximately 5 years)
Expansion Phase: Number of AEs, AESIs, and SAEs
Time frame: Through 90 days after the end of treatment (Approximately 5 years)
Expansion Phase: Overall survival (OS)
Time frame: Through the end of the study (Approximately 5 years)
Expansion Phase: Duration of response (DOR)
Time frame: Through the end of the study (Approximately 5 years)
Expansion Phase: Progression-free survival (PFS)
Time frame: Through the end of the study (Approximately 5 years)
Expansion Phase: Disease control
Time frame: Through the end of the study (Approximately 5 years)
Expansion Phase: Time to response (TTR)
Time frame: Through the end of the study (Approximately 5 years)
Expansion Phase: Ivosidenib Area under the concentration-versus-time curve (AUC) from time 0 to time of last measurable concentration (AUC0-t)
Time frame: Through the end of treatment (Approximately 5 years)
Expansion Phase: Ivosidenib AUC over 1 dosing interval at steady state (AUCtau,ss)
Time frame: Through the end of treatment (Approximately 5 years)
Expansion Phase: Ivosidenib time to maximum concentration (Tmax)
Time frame: Through the end of treatment (Approximately 5 years)
Expansion Phase: Ivosidenib maximum concentration (Cmax)
Time frame: Through the end of treatment (Approximately 5 years)
Expansion Phase: Ivosidenib trough concentration (Ctrough)
Time frame: Through the end of treatment (Approximately 5 years)
Expansion Phase: Ivosidenib apparent volume of distribution (Vd/F)
Time frame: Through the end of treatment (Approximately 5 years)
Expansion Phase: Ivosidenib apparent clearance (CL/F)
Time frame: Through the end of treatment (Approximately 5 years)
Expansion Phase: Plasma 2-hydroxygluturate (2-HG) concentrations
Time frame: Through the end of treatment (Approximately 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * Used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ivosidenib, Durvalumab (for the first 8, 21-day, cycles) and Gemcitabine (for the first 8, 21-day, cycles) in people with Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation, run by Institut de Recherches Internationales Servier at 38 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, South Korea, Germany, Spain, Brazil and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Lead-in Phase: Number of Dose-limiting toxicities (DLTs) (time frame: Through Cycle 1 (Cycle 1 is 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.