Solid Tumor, Adult Clinical Trial
Official title:
A Phase I Study Assessing the Combination of Durvalumab (MEDI4736) and Trabectedin in Solid Tumors
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.
This study will include dose escalation and dose expansion phases.
In the dose escalation portion, patients with advanced cancer will be enrolled and treated
with Durvalumab and Trabectedin. Durvalumab will be administered at the same dose in each
dose escalation cohort, while the dose of Trabectedin will be progressively increased in
different cohorts until the safest dose of the combination is determined.
In the dose expansion portion patients will be treated with the safest dose of the study
drugs determined during the dose escalation phase. There will be two separate groups of
patients treated at this dose to evaluate anti-tumor efficacy of the combination. One group
will consist of non-small-cell lung cancer patients previously treated with PD-1 or PD-L1
inhibitors and another group will consist of an immunotherapy naive group of patients. This
immunotherapy naive group of patients will include sarcoma and another tumor type, this other
tumor type will be determined based on anti-tumor efficacy seen during the dose escalation.
The study drugs will be given intravenously every 3 weeks. Treatment will continue for up to
one year or until disease progression.
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