TREMELIMUMAB for Malignant mesothelioma | Pleural mesothelioma | Peritoneal mesothelioma

Inclusion criteria

• {"criterion_text":"- Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma. Disease not amenable to curative surgery;"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Age 18 and over at the time of consent;"}
• {"criterion_text":"- ECOG Performance status 0-1;"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- Recovered from all toxicities associated with prior treatment"}
• {"criterion_text":"- Measurable disease"}
• {"criterion_text":"- Adequate bone marrow, hepatic, and renal function"}
• {"criterion_text":"- Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C."}
• {"criterion_text":"- 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;"}

Exclusion criteria

• {"criterion_text":"- Subjects who failed more than 2 prior systemic treatment regimens for advanced malignant mesothelioma"}
• {"criterion_text":"- History of sarcoidosis syndrome;"}
• {"criterion_text":"- Currently receiving systemic corticosteroids or other immunosuppressive medications;"}
• {"criterion_text":"- Subjects should not be vaccinated with live attenuated vaccines within one month prior to starting tremelimumab treatment;"}
• {"criterion_text":"- The last dose of prior chemotherapy or radiation therapy (with the exception of palliative radiotherapy) was received less than 2 weeks prior to randomization;"}
• {"criterion_text":"- Any unresolved toxicity from previous anticancer therapy;"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- Concurrent enrollment in another clinical study or receipt of an investigational product within the last 4 weeks (participation in the survival follow-up period of a study is not an exclusion criterion);"}
• {"criterion_text":"- Employees of the study site directly involved with the conduct of the study, or immediate family members of any such individuals."}
• {"criterion_text":"- Received any prior monoclonal antibody against CTLA-4, programmed cell death 1 (PD1) or programmed cell death 1 ligand 1 (PD-L1);"}
• {"criterion_text":"- History of chronic inflammatory or autoimmune disease;"}
• {"criterion_text":"- Active, untreated central nervous system (CNS) metastasis;"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- Pregnant or breast feeding at time of consent;"}
• {"criterion_text":"- Any condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocol;"}
• {"criterion_text":"- Active or history of diverticulitis. Note that diverticulosis is permitted;"}
• {"criterion_text":"- 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;"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is OS which is defined as the time from randomization until death due to any cause.","definition_or_measurement_approach":"OS defined as time from randomization until death due to any cause (measured from randomization date to date of death)."}

Secondary endpoints

• {"endpoint_text":"- The secondary efficacy endpoints include OS rate at 18 months, PRO as well as durable DCR, PFS, ORR, and duration of response, based on modified Response Evaluation Criteria in Solid Tumors (RECIST) for pleural mesothelioma and RECIST criteria v1.1 for peritoneal mesothelioma.","definition_or_measurement_approach":"OS rate at 18 months; PRO (patient-reported outcomes); durable disease-control rate (DCR), progression-free survival (PFS), overall response rate (ORR) and duration of response assessed using modified RECIST for pleural mesothelioma and RECIST v1.1 for peritoneal mesothelioma."}
• {"endpoint_text":"- The safety endpoints include adverse events (AEs) and serious adverse events (SAEs), changes from baseline in clinical laboratory evaluations, electrocardiograms (ECGs), and vital signs. Adverse events and SAEs will be assessed for severity and relationship to investigational product.","definition_or_measurement_approach":"Safety assessed by incidence and severity of AEs and SAEs, changes from baseline in labs, ECGs, and vital signs; AEs/SAEs assessed for severity and relationship to investigational product."}
• {"endpoint_text":"- The immunogenic potential of tremelimumab will be analyzed and the pharmacokinetics of tremelimumab will be assessed.","definition_or_measurement_approach":"Immunogenicity analyses (anti-drug antibodies) and pharmacokinetic assessments of tremelimumab."}

Italy

Earliest CTIS Part Ii Submission Date

16-04-2024

Latest Decision Or Authorization Date

24-01-2025

Processing Time Days

283

Number Of Sites

1

Number Of Participants

1

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Syneos Health Netherlands B.V.

Responsibilities

sponsorDuties codes: 1, 12, 5

Third parties

• {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"sponsorDuties codes: 1, 12, 5","organisation_type":"Pharmaceutical company"}