A Study of Tremelimumab Combined With the Anti-PD-L1 MEDI4736 Antibody in Malignant Mesothelioma (NIBIT-MESO-1)

Sponsor
Italian Network for Tumor Biotherapy Foundation
Study ID
NCT02588131
Phase
PHASE2
Status
Unknown

Conditions

  • Peritoneal Mesothelioma
  • Pleural Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tremelimumab plus MEDI4736 — DRUG
    tremelimumab1 mg/kg i.v over 60 minutes plus MEDI 4736 20 mg/kg i.v every four weeks for 4 doses, then MEDI4736 20 mg/kg IV every four weeks for additional 9 doses.

Study Details

This phase 2, open-label, single arm study aims to evaluate the efficacy of tremelimumab in combination with the anti-PD-L1 MEDI4736 in patients with unresectable malignant mesothelioma subjects

Key Dates

Start date
Oct 31, 2015
Status verified
Oct 2015
Primary completion
Jun 30, 2016
Completion
Mar 31, 2018

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: tremelimumab plus MEDI4736
    Tremelimumab in combination with MEDI4736

Primary Outcome Measure

immune-related (ir)- objective response rate (ORR) [ Time Frame: 60 weeks ]

Central Contacts

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