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Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation

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Servier Protocol Code: S095031-210 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT06501625 EU Trial (CTIS) Number: 2024-514261-19-00

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 28 locations

Study description

The study is needed to test a new drug called ivosidenib. It will be tested in combination with other approved treatments called durvalumab and gemcitabine/cisplatin. The study involves participants with cholangiocarcinoma. Cholangiocarcinoma is also known as bile duct cancer. The bile duct is the tube that moves bile through the liver, gallbladder and small intestine. The study focuses on patients with advanced cancer that cannot be removed by surgery (called unresectable) or has spread to other parts of the body (called metastatic).

This study focuses on patients with cholangiocarcinoma who have a specific gene change called an isocitrate dehydrogenase 1 (IDH1) mutation. In several types of cancer such as cholangiocarcinoma, an abnormal (mutated) form of a protein called IDH is present in the cancer cells due to changes called mutations. These abnormal proteins make too much 2-hydroxyglutarate (2-HG). Too much 2-HG can stop normal cell functioning and may cause cells to become cancer cells.

Ivosidenib is a drug that blocks the activity of abnormal IDH1 proteins and lower 2-HG levels in tumor cells to normal levels. Ivosidenib is already approved in some countries for treating patients with other types of cancer with an IDH1 mutation.

The main goals of the study are:

  • To see how safe and well-tolerated the combination of ivosidenib, durvalumab, and gemcitabine/cisplatin is in participants with advanced cholangiocarcinoma with an IDH1 mutation.
  • To find the recommended dose (the one that is both safe and effective for patients) of ivosidenib to use with durvalumab and gemcitabine/cisplatin.
  • To see how well the combination of ivosidenib, durvalumab, and gemcitabine/cisplatin works as a treatment for patients with advanced cholangiocarcinoma.
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
Conditions
Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Interventions / Treatments
  • 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)
Other study id numbers
  • S095031-210

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants have to:

  • Be adults aged 18 or older.
  • Weigh more than 30 kilograms.
  • Have a documented IDH1 mutation in their tumour.
  • Be generally healthy, with adequate bone marrow (the spongy tissue inside bones where blood cells are made), liver and kidneys function.

Participants cannot take part in the study if:

  • Their cancer has spread to the brain, requiring treatment with steroids.
  • They have previously received treatment for their advanced, unresectable or metastatic cancer.
  • They have previously received immune therapy.

How is the study designed?

Allocation
Non-randomized
Interventional study model
Sequential
Participant Group / Arm
Experimental: Safety Lead-In Phase

Participants receive the ivosidenib, durvalumab, and gemcitabine/cisplatin combination to assess safety.

Intervention / Treatment
Drug: Ivosidenib

Participants take two 250 mg tablets by mouth once a day, every day.

Drug: Durvalumab

Participants receive 1500 mg of durvalumab through an IV (intravenous) drip every 3 weeks, for the first 8 cycles, each cycle lasting 21 days.

Drug: Gemcitabine

Participants receive 1000 mg/m² of gemcitabine through an IV (intravenous) drip on days 1 and 8 of each 21-day cycle, for up to 8 cycles.

Drug: Cisplatin

Participants receive 25 mg/m² of cisplatin through an IV (intravenous) drip on days 1 and 8 of each 21-day cycle, for up to 8 cycles.

Drug: Durvalumab

Starting from cycle 9, participants receive 1500 mg of durvalumab through an IV (intravenous) drip every 4 weeks. Each cycle from cycle 9 onward lasts 28 days.

Participant Group / Arm
Experimental: Dose expansion

Participants receive different doses of the ivosidenib, durvalumab, and gemcitabine/cisplatin combination to find the recommended dose.

Intervention / Treatment
Drug: Durvalumab

Participants receive 1500 mg of durvalumab through an IV (intravenous) drip every 3 weeks, for the first 8 cycles, each cycle lasting 21 days.

Drug: Gemcitabine

Participants will receive 1000 mg/m² of gemcitabine through an IV (intravenous) drip on days 1 and 8 of each 21-day cycle, for up to 8 cycles.

Drug: Cisplatin

Participants will receive 25 mg/m² of cisplatin through an IV (intravenous) drip on days 1 and 8 of each 21-day cycle, for up to 8 cycles.

Drug: Durvalumab

Starting from cycle 9, participants will receive 1500 mg of durvalumab through an IV (intravenous) drip every 4 weeks. Each cycle from cycle 9 onward will last 28 days.

Drug: Ivosidenib Recommended

Combination Dose (RCD) Participants will take the recommended combination dose of ivosidenib by mouth once a day, every day during the treatment.