drugset / Trial / NCT03496519

Assessing the Combination of Durvalumab (MEDI4736) and Trabectedin in Solid Tumors

NCT03496519

Phase 1 Withdrawn University of Colorado, Denver
Non-randomizedSingle-groupOpen-labelTreatment

Summary

A phase 1 study examining the combination of Durvalumab (MEDI4736) and Trabectedin in various solid tumor types. The study seeks to determine a safe dose of the combination of study drugs and then examine this dose in larger groups of patients of specific tumor types to evaluate its anti-tumor efficacy. Treatment will continue in patients who respond for up to 1 year.

Timeline

Start
2018-10-01
Primary completion
2021-10-31
Completion
2021-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1125 mg Intravenous
Subject Trabectedin Small molecule 0.5 mg/m2 Intravenous
Subject Trabectedin Small molecule 0.75 mg/m2 Intravenous
Subject Trabectedin Small molecule 1 mg/m2 Intravenous
Subject Trabectedin Small molecule 1.2 mg/m2 Intravenous
Subject Trabectedin Small molecule 1.5 mg/m2 Intravenous

Indications