MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

• Status: Recruiting
• Trial end date: 2028-03-13
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Carboplatin; Ipilimumab; Nivolumab; Pemetrexed

Criteria

Key Inclusion Criteria:

• 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

Key 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