CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
Combination of trabectedin with durvalumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03085225
NCT03085225Phase 1Completed
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Trabectedin Combined With Durvalumab (MEDI4736) in Patients With Advanced Pretreated Soft-tissue Sarcomas and Ovarian Carcinomas. A Phase Ib Study.

Institut Bergonié·interventional·Posted Mar 21, 2017·Updated Sep 4, 2025

In Brief

A Phase 1 clinical trial evaluating Combination of trabectedin with durvalumab for Ovarian Carcinoma and Soft Tissue Sarcoma. Completed, enrolled 40 participants across 2 sites.

Detailed Summary

A phase Ib trial study of trabectedin when prescribed in combination with durvalumab in locally advanced/unresectable soft-tissue sarcoma and ovarian carcinomas.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Carcinoma, Soft Tissue Sarcoma
CountriesFrance
CollaboratorsAstraZeneca, PharmaMar

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 21, 2017
Enrollment StartMay 5, 2017
Primary CompletionNov 19, 2020
Study CompletionJan 4, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.3 years ago

Interventions

Combination of trabectedin with durvalumabdrug

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.