Tremelimumab for Mesothelioma

(Tremelimumab Trial)

Recruiting in Palo Alto (17 mi)

+99 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: MedImmune LLC

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults over 18 with confirmed pleural or peritoneal malignant mesothelioma who have progressed after 1-2 systemic treatments including a pemetrexed-based regimen. They must have measurable disease, adequate organ function, no HIV or hepatitis, and not be candidates for curative surgery. Participants should use effective contraception and cannot join if they've had certain autoimmune diseases, other cancers within 3 years (except some exceptions), recent chemotherapy or radiation, severe allergies to similar drugs, active infections, CNS metastasis, are pregnant/breastfeeding or unable to consent.

Inclusion Criteria

Written informed consent and any locally required authorization obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations

My advanced disease worsened after 1-2 treatments including a pemetrexed-platinum combo.

You have a measurable disease in the chest or abdominal lining.

Exclusion Criteria

Pregnant or breast feeding at time of consent

Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results

Any condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocol

Treatment Details

Interventions

• Placebo (Other)
• Tremelimumab (Checkpoint Inhibitor)

Trial Overview The study compares Tremelimumab (a new treatment) with a placebo in patients with unresectable malignant mesothelioma. It's randomized (patients are assigned by chance) and double-blind (neither the researchers nor participants know who gets the real treatment). The ratio of assignment is two patients on Tremelimumab for every one patient on placebo across multiple countries.

Participant Groups

Group I: Tremelimumab Experimental Treatment 1 Intervention

Tremelimumab

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

MedImmune LLC

Lead Sponsor

Trials

348

Recruited

788,000+

Founded

1988

Headquarters

Gaithersburg, USA

Known For

Biologics research

Top Products

Synagis, FluMist

Dr. Reginald Seeto

MedImmune LLC

Chief Medical Officer since 2008

MD from University of Sydney, B.Sc. from University of Sydney

Peter Greenleaf

MedImmune LLC

Chief Executive Officer since 2006

MBA from St. Joseph’s University, B.S. from Western Connecticut State University