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Active Not Recruiting NCT06097728

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Conditions: Unresectable Pleural Mesothelioma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 861
Sponsor: AstraZeneca

Location: Research Site Santa Rosa California

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.

Eligibility 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06097728). StuddyBuddy aggregates publicly available trial information.