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Clinical Trials (PDQ®)

Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overPharmaceutical / IndustryD4880C00003
NCT01843374

Trial Description

Summary

This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.

Further Study Information

This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo.

Randomization will be stratified by EORTC status (low-risk vs high-risk), line of therapy (second vs third), and anatomical site (pleural vs peritoneal). This study plans to use the EORTC to stratify subjects into high or low risk groups in order to ensure balanced randomization to the different treatment groups. For subjects in whom pemetrexed was contraindicated or not tolerated or not an approved therapy (eg, peritoneal mesothelioma), prior therapy with a first-line platinum-based regimen is required. Approximately 564 subjects will be enrolled at study centers in multiple countries.

The study consists of a screening period, a treatment period, and a 90-day follow-up period.

Eligibility Criteria

Inclusion Criteria:

  • Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma. Disease not amenable to curative surgery;
  • Age 18 and over at the time of consent;
  • ECOG Performance status 0-1;
  • Progressed after previous receipt of 1-2 prior systemic treatment for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent;
  • Recovered from all toxicities associated with prior treatment; - Measurable disease;
  • Adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

  • Received any prior monoclonal antibody against CTLA-4, programmed cell death 1 (PD1) or programmed cell death 1 ligand 1 (PD-L1);
  • History of chronic inflammatory or autoimmune disease;
  • Active, untreated central nervous system (CNS) metastasis;
  • History of other malignancy unless the subject has been disease-free for at least 3 years;
  • Active or history of diverticulitis. Note that diverticulosis is permitted;
  • Active or history of inflammatory bowel disease (eg, colitis, Crohn's), irritable bowel disease, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea. Active or history of systemic lupus erythematosis or Wegener's granulomatosis;
  • History of sarcoidosis syndrome;
  • Currently receiving systemic corticosteroids or other immunosuppressive medications;
  • The last dose of prior chemotherapy or radiation therapy (with the exception of palliative radiotherapy) was received less than 2 weeks prior to randomization;
  • Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy; with the exception of vitiligo and alopecia.

Trial Contact Information

Trial Lead Organizations/Sponsors

MedImmune, Incorporated

MedImmune Contact
  Email: ClinicalTrialEnquiries@Medimmune.com

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Research Site
California
  La Jolla
 Research Site
  Los Angeles
 Research Site
  San Francisco
 Research Site
  Santa Monica
 Research Site
Connecticut
  New Haven
 Research Site
Delaware
  Newark
 Research Site
Florida
  Tampa
 Research Site
Georgia
  Augusta
 Research Site
Illinois
  Chicago
 Research Site
  Peoria
 Research Site
Maryland
  Baltimore
 Research Site
Minnesota
  Minneapolis
 Research Site
New York
  New York
 Research Site
  Rochester
 Research Site
North Carolina
  Durham
 Research Site
Ohio
  Canton
 Research Site
  Cleveland
 Research Site
Oregon
  Portland
 Research Site
Pennsylvania
  Philadephia
 Research Site
Texas
  Dallas
 Research Site
  Houston
 Research Site
Australia
  Adelaide
 Research Site
  Auchenflower
 Research Site
  Box Hill
 Research Site
  Chermside
 Research Site
  East Bentleigh
 Research Site
  Garran
 Research Site
  Gosford
 Research Site
  Heidelberg
 Research Site
  Nedlands
 Research Site
  Saint Leonards
 Research Site
  Southport
 Research Site
  Waratah
 Research Site
Belgium
  Antwerp
 Research Site
  Gent
 Research Site
  Leuven
 Research Site
Canada
Ontario
  Toronto
 Research Site
Quebec
  Montreal
 Research Site
  Sainte Foy
 Research Site
Denmark
  Copenhagen
 Research Site
France
  Caen Cedex
 Research Site
  Clamart Cedex
 Research Site
  Le Mans Cedex
 Research Site
  Lille Cedex
 Research Site
  Nice Cedex
 Research Site
  Rennes
 Research Site
  Toulouse Cedex 9
 Research Site
  Villejuif Cedex
 Research Site
Germany
  Berlin
 Research Site
  Dresden
 Research Site
  Esslingen a.N.
 Research Site
  Gauting
 Research Site
  Hamburg
 Research Site
  Hemer
 Research Site
  Karlsruhe
 Research Site
  Löwenstein
 Research Site
  Lubeck
 Research Site
Hungary
  Matrahaza
 Research Site
  Törökbálint
 Research Site
Israel
  Beer-Sheva
 Research Site
  Jerusalem
 Research Site
Italy
  Alessandria
 Research Site
  Ancona
 Research Site
  Aviano
 Research Site
  Bergamo
 Research Site
  Candiolo
 Research Site
  Meldola
 Research Site
  Milano
 Research Site
  Orbassano
 Research Site
  Padova
 Research Site
  Rozzano
 Research Site
  Siena
 Research Site
Netherlands
  Breda
 Research Site
  Eindhoven
 Research Site
  Rotterdam
 Research Site
Poland
  Gdansk
 Research Site
  Poznan
 Research Site
  Szczecin
 Research Site
  Warszawa
 Research Site
Republic of Korea
  Seoul
 Research Site
Republic of South Africa
  Kraaifontein
 Research Site
  Port Elizabeth
 Research Site
  Pretoria
 Research Site
Romania
  Craiova
 Research Site
Russia
  Moscow
 Research Site
  Nizhny Novgorod
 Research Site
  Saint-Petersburg
 Research Site
Spain
  Barcelona
 Research Site
  Madrid
 Research Site
  Sabadell
 Research Site
  San Sebastian
 Research Site
  Sevilla
 Research Site
Sweden
  Linkoping
 Research Site
  Lund
 Research Site
United Kingdom
  Leeds
 Research Site
  Leicester
 Research Site
  London
 Research Site
  Maidstone
 Research Site
  Manchester
 Research Site
  Plymouth
 Research Site
  Southampton
 Research Site
  Wirral
 Research Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01843374
ClinicalTrials.gov processed this data on December 15, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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