Unresectable Pleural Mesothelioma
Conditions
Interventions
Biologic: Volrustomig
Drug: Pemetrexed
Drug: Carboplatin
Drug: Cisplatin
Biologic: Nivolumab
Biologic: Ipilimumab
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be 18 years or more at the time of screening - Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid) - Advanced unresectable disease that cannot be treated with curative surgery (with or without chemotherapy) - WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS>1) over the previous 2 weeks prior to day of first dosing - Has measurable disease per modified RECIST1.1 - Has adequate bone marrow reserve and organ function at baseline
Exclusion criteria
Exclusion criteria: - As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results. - Active or prior documented autoimmune or inflammatory disorders - History of another primary malignancy with exceptions. - Uncontrolled intercurrent illness - Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlled - Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment - Untreated or progressive CNS metastatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) in experimental arm relative to comparator arm [ Time Frame: up to approximately 61 months ] OS is defined as the time from randomization until the date of death due to any cause. | — |
Countries
Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Norway, Poland, South Afric, South Korea, Spain, Switzerland, Taiwan, Turkey, UK, USA
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed