MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT02592551
Phase
PHASE2
Status
Completed

Conditions

  • Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • MEDI4736 — DRUG
    MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.
  • Tremelimumab — DRUG
    Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume \[w/v\]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5.
  • no other name — OTHER
    Neither MEDI4736 nor Tremelimumab will be used.

Study Details

The objective of this study is to determine whether MEDI4736 or combination therapy with MEDI4736 + tremelimumab are associated with favorable alterations of the intratumoral immunologic environment in subjects undergoing resectional surgery for Malignant Pleural Mesothelioma MPM.

Key Dates

Start date
May 11, 2016
Status verified
Sep 2022
Primary completion
Aug 6, 2019
Completion
Sep 1, 2022

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: MEDI4736
    8 patients will receive an infusion of MEDI4736 (15 mg/kg intravenously, once), one to six weeks prior to surgical resection.
  • Active Comparator: MEDI4736 + Tremelimumab
    8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection.
  • Placebo Comparator: Untreated arm (control)
    4 patients will not receive MEDI4736 or Tremelimumab.

Primary Outcome Measure

Change in Ratio of Intratumoral Cytotoxic T Cells to Regulatory T Cells (CD8/Treg) [ Time Frame: at day 1 after screening and at a surgery within one to six weeks after treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor St LukesHoustonTexas77030-

Find similar trials in Houston, TX

By research site
Baylor St Lukes· Houston, TX

Related Studies