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RECRUITINGPhase 3INTERVENTIONAL

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination With Carboplatin Plus Pemetrexed Versus Platinum Plus Pemetrexed or Nivolumab Plus Ipilimumab in Participants With Unresectable Pleural Mesothelioma (eVOLVE-Meso)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Key Who May Qualify: - 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/You should be able to carry out daily activities with 0 level of ability (ECOG 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 Who Should NOT Join This Trial: - 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 weakened immune system 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Volrustomig

MEDI5752: Administered as IV infusion

DRUG

Pemetrexed

Alimta: Administered as IV infusion

DRUG

Carboplatin

Paraplatin: Administered as IV infusion

DRUG

Cisplatin

Platinol: Administered as IV infusion

DRUG

Nivolumab

Opdivo: Administered as IV infusion

DRUG

Ipilimumab

Yervoy: Administered as IV infusion

Locations (20)

Research Site
Phoenix, Arizona, United States
Research Site
Duarte, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Jacksonville, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Baltimore, Maryland, United States
Research Site
Rochester, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
East Brunswick, New Jersey, United States
Research Site
Commack, New York, United States
Research Site
Valhalla, New York, United States
Research Site
Cleveland, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Independence, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Portland, Oregon, United States