Brief 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.
Intervention / Treatment
- Drug: Volrustomig
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Nivolumab
- Drug: Ipilimumab
Key Inclusion Criteria:
- Participant must be ≥ 18 years at the time of screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening
- Histologically proven diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid)
- Advancedat a late stage, far along unresectable disease that cannot be treated with curative surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence (with or without chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells)
- 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 marrowsoft, spongy tissue found in bones that makes blood cells reserve and organ function at baseline