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MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06097728.
