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

Sponsor
University of Colorado, Denver
Study ID
NCT03496519
Phase
PHASE1
Status
Withdrawn

Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Dose Escalation of Durvalumab and Trabectedin — DRUG
    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
  • Dose Expansion of Durvalumab and Trabectedin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 1, 2018
Status verified
Oct 2018
Primary completion
Oct 31, 2021
Completion
Oct 31, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Dose escalation will occur following a 3+3 design in all advanced tumor types meeting the inclusion and exclusion criteria. * Cohort -1 (if necessary): 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
  • Experimental: Dose Expansion
    Patients at this level will receive the safest dose of Durvalumab and Trabectedin that was determined during the Dose Escalation Phase. There will be a fixed dosage of Durvalumab, 1125mg, given intravenously over 60 minutes on Day 2 every 21 days. There will be fixed dosage of Trabectedin for each cohort, given through intravenous infusion as an outpatient, over a 24 hour period on Day 1 every 21 days.

Primary Outcome Measure

Recommended Dosage of the Durvalumab and Trabectedin Combination [ Time Frame: Up to 1 year on study treatment plus 90 days safety follow-up, up to 15 months ]

Related Studies