MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
18 Years and older, Male and Female
D7988C00001 (primary)
NCI-2024-02750
2023-000067-32
2023-503231-17-00
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.
Objectives
Adult patients with histologically proven diagnosis of pleural mesothelioma with advanced
unresectable disease are eligible to be enrolled. Patients will be randomized 1:1 to
receive Volrustomig (MEDI5752) + Carboplatin + Pemetrexed or the investigator's choice of
platinum+Pemetrexed or Nivolumab+Ipilimumab, based on their histology.
Eligibility
- 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
Treatment Sites in Georgia
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