EUCTR2012-003524-21-DK
Active, not recruiting
Phase 1
A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma
Conditionsunresectable pleural or peritoneal malignant mesotheliomaMedDRA version: 19.0Level: LLTClassification code 10034670Term: Peritoneal mesothelioma malignant localisedSystem Organ Class: 100000004864MedDRA version: 19.0Level: LLTClassification code 10035606Term: Pleural mesothelioma malignant localisedSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- unresectable pleural or peritoneal malignant mesothelioma
- Sponsor
- MedImmune, LLC
- Enrollment
- 564
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following 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 treatments for advanced disease that included a first\-line pemetrexed (or anti\-folate)\-based regimen in combination with a platinum agent;
- •\- Previous receipt of 1\-2 prior systemic chemotherapies that included 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
- •\- Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C.
Exclusion Criteria
- •Any of the following would exclude the subject from participation in the study:
- •\- Subjects who failed more than 2 prior systemic treatment regimens for advanced malignant mesothelioma;
- •\- 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. Non\-invasive cancer history (such as carcinoma in situ \[CIS] that has been resected) is allowed;
- •\- Pregnant or breast feeding at time of consent;
- •\- Any condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocol;
- •\- Active or history of diverticulitis. Note that diverticulosis is permitted;
- •\- Active or history of inflammatory bowel disease (eg, colitis,
Outcomes
Primary Outcomes
Not specified
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