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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

December 16, 2024

Primary Completion Date

July 23, 2026

Study Completion Date

September 13, 2027

Conditions
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

Trial Locations (28)

3004

NOT_YET_RECRUITING

Alfred Health, Melbourne

3080

RECRUITING

Seoul National University Hospital, Seoul

3722

RECRUITING

Severance, Seoul

6591

RECRUITING

Seoul St. Mary'S Hospital, Seoul

8035

RECRUITING

H. Valle de Hebron, Barcelona

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

13353

RECRUITING

Charite Universitatsmedizin, Berlin

13496

RECRUITING

Cha Bundang Medical Center, Seongnam

13620

RECRUITING

Seoul National University Bundang Hospital, Seongnam

28007

RECRUITING

Hospital Universitario Gregorio Marañón, Madrid

28040

RECRUITING

H. 12 de Octubre, Madrid

NOT_YET_RECRUITING

Hospital Universitario Fundación Jiménez Díaz, Madrid

29303

NOT_YET_RECRUITING

Gibbs Cancer Center, Spartanburg

30625

NOT_YET_RECRUITING

Medizinische Hochschule Hannover Oe 6810, Hanover

33076

RECRUITING

Institut Bergonie, Bordeaux

33612

NOT_YET_RECRUITING

Moffitt Cancer Center, Tampa

34295

RECRUITING

Chu Montpellier-Hopital Saint-Eloi, Montpellier

40225

RECRUITING

Universitätsklinikum Düsseldorf, Düsseldorf

60488

RECRUITING

Universitären Centrums Für Tumorerkrankungen (Uct) Der J.W. Goethe-Universität Frankfurt, Frankfurt

60611

RECRUITING

Northwestern Medicine, Chicago

89081

NOT_YET_RECRUITING

Universitätsklinikum Ulm, Ulm

90033

RECRUITING

Usc Norris Comprehensive Cancer Center, Los Angeles

92210

RECRUITING

Hôpital Beaujon, Clichy

98109

NOT_YET_RECRUITING

Fred Hutchinson Cancer Center, Seattle

277-8577

RECRUITING

National Cancer Center Hospital East, Kashiwa

104-0045

RECRUITING

National Cancer Center Hospital, Chūōku

606-8507

RECRUITING

Kyoto University Hospital, Kyoto

241-8515

RECRUITING

Kanagawa Cancer Center, Yokohama

All Listed Sponsors
lead

Institut de Recherches Internationales Servier

OTHER