Mesothelioma.com Resources for Patients and their Families

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

Brief 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.

Tracking Information
First Received DateApril 22, 2013
Last Changed DateJanuary 24, 2017
Start DateMay 2013
Actual Primary Completion DateJanuary 2016
Primary Outcome Measures

Overall survival (OS) time by treatment arm [Time Frame: Time from randomization until death due to any cause, assessed up to 3 years.]

Secondary Outcome Measures

Durable disease control rate by treatment arm [Time Frame: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.]

Length of progression-free survival by treatment arm [Time Frame: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.]

Overall response rate by treatment arm [Time Frame: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.]

Duration of response by treatment arm [Time Frame: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.]

Number of participants reporting any adverse event [Time Frame: Day 1- 90 days post dose]

Number of participants with changes in patient-reported outcomes [Time Frame: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.]

Number of participants reporting any serious adverse events [Time Frame: Day 1 to 90 days post dose]

Number of participants with anti-drug antibodies [Time Frame: Week 5]

Tremelimumab blood concentration [Time Frame: Week 5]

OS rate at 18 months [Time Frame: Time from randomization until death, due to any cause, or alive at 18 months.]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Unresectable Pleural or Peritoneal Malignant Mesothelioma
Intervention
  • Drug: Tremelimumab
  • Drug: Placebo
Study Arms / Comparison Groups2 / 0
Detailed Description

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.

Recruitment Information
Recruitment StatusActive, not recruiting
Actual Enrollment658
GenderAll
Ages18 Years - 99 Years
Accepts Healthy VolunteersNo
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.

Administrative Information
NCTIDNCT01843374
Responsible Party,
SponsorMedImmune LLC
Verification DateJanuary 2017
Mesothelioma Doctors by State
  • Breaking News
  • Emerging Clinical Trials
  • Delivered within 24 hrs

Yes   No

Mesothelioma Cancer Alliance Blog

FEATURED CONTENT:


RECENT POSTS:

Medical Marijuana for Cancer: What to Know

How to Stay Safe During Asbestos Cleanups

Dr. Raja Flores Explains the Tools Used in Mesothelioma Surgery

Mesothelioma Treatment Guide

Free Mesothelioma Treatment Guide

Please fill in the form below to request our FREE Mesothelioma Treatment Guide. It will be sent to you within 24 hours.

Have you or someone you know been diagnosed with mesothelioma?

Get Access To: