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

NCT02588131 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-10-27

No results posted yet for this study

Summary

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

Conditions

  • Pleural Mesothelioma
  • Peritoneal Mesothelioma

Interventions

DRUG

tremelimumab plus MEDI4736

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Italian Network for Tumor Biotherapy Foundation

    lead OTHER

Principal Investigators

  • Luana Calabro', MD, PhD · Medical Oncology and Immunotherapy Division, Univeristy Hospital os Siena, Siena, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-06-30
Completion
2018-03-31

Countries

  • Italy

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02588131 on ClinicalTrials.gov