NCT03496519

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

A Phase I Study Assessing the Combination of Durvalumab (MEDI4736) and Trabectedin in Solid Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	Dose Escalation of Durvalumab and Trabectedin	There will be a fixed dosage of Durvalumab, 1125mg, given intravenously over 60 minutes on Day 2 every 21 days. There will be an increase in Trabectedin for each cohort, given through intravenous infusion over a 24 hour period on Day 1 every 21 days as an outpatient. * Cohort -1: Durvalumab 1125mg with Trabectedin 0.5mg/m2 * Cohort 1: Durvalumab 1125mg with Trabectedin 0.75mg/m2 * Cohort 2: Durvalumab 1125mg with Trabectedin 1.0mg/m2 * Cohort 3: Durvalumab 1125mg with Trabectedin 1.2mg/m2 * Cohort 4: Durvalumab 1125mg with Trabectedin 1.5mg/m2
DRUG	Dose Expansion of Durvalumab and Trabectedin	There will be a fixed dosage of Durvalumab, 1125mg, given intravenously over 60 minutes on Day 2 every 21 days. There will be a fixed dosage of Trabectedin for each cohort, whatever was determined to be the safest dose during the Dose Escalation Phase, and it will be given through intravenous infusion over a 24 hour period on Day 1 every 21 days as an outpatient.

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2018-04-12
• Last updated: 2018-10-09

Regulatory

• FDA-regulated drug study