A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT03075527
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Mesothelioma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tremelimumab — DRUGTremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
- Durvalumab — DRUGDurvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
Study Details
This research study is studying a pair of immunotherapies as a possible treatment for malignant pleural mesothelioma. The drugs involved in this study are: * Durvalumab * Tremelimumab
Key Dates
- Start date
- Apr 10, 2017
- Status verified
- Dec 2025
- Primary completion
- Jun 7, 2019
- Completion
- Dec 16, 2024
Study Design
- Enrollment
- 19 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Tremelimumab + DurvalumabSubjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
Primary Outcome Measure
Overall Response Rate (ORR) [ Time Frame: ORR was assessed every 8 weeks from Cycle 1 Day 1 until date of documented disease progression or death. The median treatment duration is 1.91 months with range (0.00 months - 23.46 months). ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
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