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 — DRUG
    Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
  • Durvalumab — DRUG
    Durvalumab 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 + Durvalumab
    Subjects 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)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-

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