NL-OMON41613
Completed
Phase 2
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 - MedImmune Protocol D4880C00003 Tremelimumab
Medimmune LLC, subsidiary of AstraZeneca0 sites32 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- inoperabel maligne mesothelioom
- Sponsor
- Medimmune LLC, subsidiary of AstraZeneca
- Enrollment
- 32
- Status
- Completed
- Last Updated
- 2 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 receipt of 1\-2 prior systemic treatments for advanced disease that include 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 ;\- Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C. ;\- Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive authorization in the EU) obtained from the subject/legal representative prior to performing any protocol\-related procedures, including screening evaluations;;\- Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product;;\- Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through 90 post last dose.
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;
- •\- Any serious uncontrolled medical disorder or active infection that would impair the subject's ability to receive investigational product, such as conditions associated with frequent diarrhea
- •\- 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;
Outcomes
Primary Outcomes
Not specified
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