Skip to content
Find Clinical Trials
Find Clinical Trials
Home » Find Clinical Trials » Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation

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

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

Find a recruiting site

How to participate in this 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 can’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 37 locations

Study description

This study is done to test a drug called ivosidenib in combination with durvalumab and gemcitabine/cisplatin in participants with a type of severe bile duct cancer (cholangiocarcinoma) that cannot be treated with surgery. Bile ducts are tiny tubes carrying bile from the liver to the intestine. Bile helps to digest fats in food. In several types of cancer such as cholangiocarcinoma, an abnormal (mutated) form of a protein called isocitrate dehydrogenase 1 (IDH1) is present in the tumor cells due to gene changes called mutations. This leads to the overproduction of 2-hydroxyglutarate (2-HG), a substance that is normally present in cells at low levels. Too much 2-HG impairs normal cell functioning and may cause them to become tumor cells.

Ivosidenib is a drug that blocks the activity of abnormal IDH1 proteins, which reduces 2-HG levels in tumor cells back to normal levels.

Researchers believe that combining ivosidenib with other approved treatments called durvalumab and gemcitabine/cisplatin might help treat these cancers better and improve the lives of people who have them.

The main goals of this study are:

Part 1:

  • To look at the safety and tolerability of ivosidenib in combination with durvalumab and gemcitabine/cisplatin and to find the best (recommended) dose for this combination.

Part 2:

  • To see how well ivosidenib in combination with durvalumab and gemcitabine/cisplatin works in treating the tumor.
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)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part, participants have to:

  • Be adults aged 18 or older.
  • Have a documented IDH1 mutation in their tumor.
  • Have cholangiocarcinoma that has spread to nearby areas (locally advanced) or other organs (metastatic) in the body and cannot be removed by surgery.
  • Have adequate bone marrow (the spongy tissue inside bones where blood cells are made), liver, and kidney 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.