Phase III Trial of Volrustomig (MEDI5752) in Combination with Carboplatin plus Pemetrexed vs. Investigator’s Choice of the Standard of Care in Unresectable Pleural Mesothelioma
- Conditions
- nresectable Pleural MesotheliomaTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503231-17-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 621
Participant must be = 18 years 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method