Study Comparing Tremelimumab to a Placebo in Patients with Unremovable Malignant Mesothelioma

Sponsor: MedImmune LLC

Sponsor score: 0

ClinicalTrials ID:NCT01843374

Provider View

This clinical trial is testing whether the drug tremelimumab can help treat patients with malignant mesothelioma that cannot be removed by surgery. Participants will be randomly assigned to receive either tremelimumab or a placebo, and the study will take place in multiple countries.

Patient Parameters

Program Overview

This study is designed to find out if tremelimumab is effective in treating malignant mesothelioma that cannot be surgically removed. Participants will be randomly assigned to receive either tremelimumab or a placebo, with a higher chance of receiving tremelimumab. The study will involve a screening period, a treatment period, a 90-day follow-up for safety, and a long-term follow-up to monitor survival. Approximately 564 participants will be enrolled from various countries.

Description

This study aims to evaluate the effectiveness of tremelimumab in treating malignant mesothelioma that cannot be removed by surgery. Participants will be randomly assigned to receive either tremelimumab or a placebo, with a 2:1 chance of receiving tremelimumab. The study will consider factors like risk level, previous treatments, and cancer location to ensure balanced groups.

Participants must have previously received certain chemotherapy treatments unless they were not suitable or available. The study will take place in multiple countries and will include a screening period, a treatment period, a 90-day follow-up for safety, and a long-term follow-up to monitor survival.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pleural or peritoneal malignant mesothelioma that cannot be removed by surgery.
  • Aged 18 or older.
  • In good general health, with a performance status of 0 or 1.
  • Have received 1-2 prior treatments for advanced disease, including a specific chemotherapy regimen.
  • Recovered from previous treatment side effects to a mild level.
  • Have measurable disease based on specific criteria.
  • Have adequate bone marrow, liver, and kidney function.
  • Test negative for HIV and hepatitis A, B, and C.
  • Provide written informed consent.
  • Women of childbearing potential must use effective contraception before and after treatment.
  • Men must use effective contraception and avoid donating sperm for a specified period after treatment.

Exclusion Criteria

  • Have received more than 2 prior treatments for mesothelioma.
  • Have received certain types of immunotherapy before.
  • Have a history of certain autoimmune or inflammatory diseases.
  • Have untreated cancer spread to the brain.
  • Have serious uncontrolled medical conditions or infections.
  • Have had another cancer unless disease-free for at least 3 years.
  • Are pregnant or breastfeeding.
  • Have conditions that prevent understanding or following the study requirements.
  • Have a history of certain bowel diseases or conditions.
  • Are taking certain medications that affect the immune system.
  • Have received live vaccines recently.
  • Have unresolved side effects from previous cancer treatments.
  • Are participating in another clinical study or have recently received another investigational treatment.
  • Are employees or family members of the study site staff.
  • Have allergies to similar drugs or ingredients in tremelimumab.

Locations

FACILITYZIPCITYSTATE
Research Site85259ScottsdaleArizona
Research Site92093La JollaCalifornia
Research Site90025Los AngelesCalifornia
Research Site94143San FranciscoCalifornia
Research Site90404Santa MonicaCalifornia
Research Site06511New HavenConnecticut
Research Site19718NewarkDelaware
Research Site33612TampaFlorida
Research Site30912AugustaGeorgia
Research Site60637ChicagoIllinois

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