Trabectedin Combined With Durvalumab in Patients With Advanced Pretreated Soft-tissue Sarcomas and Ovarian Carcinomas.

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 5, 2017

Primary Completion Date

November 19, 2020

Study Completion Date

January 4, 2022

Conditions
Ovarian CarcinomaSoft Tissue Sarcoma
Interventions
DRUG

Combination of trabectedin with durvalumab

"Dose Escalation : 3 doses of trabectedin given in combination with durvalumab (fixed dose) will be investigated.~A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.).~Expansion cohorts: Once the Maximum Tolerated Dose (MTD) has been defined, the expansion cohorts will be opened. All patients will be treated at the MTD of Trabectedin (as defined in the dose escalation part of the trial) given in association with Durvalumab with the same schedule as in the dose escalation part of the trial."

Trial Locations (2)

33076

Institut Bergonié, Bordeaux

69373

Centre Léon Bérard, Lyon

Sponsors

Lead Sponsor

Collaborators (2)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

PharmaMar

INDUSTRY

lead

Institut Bergonié

OTHER