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MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Purpose

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.

Condition

Unresectable Pleural Mesothelioma

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, open-label, Phase III trial in participants with untreated unresectable pleural mesothelioma. Approximately 825 participants across histology subtypes will be randomized in a 1:1 ratio to receive volrustomig in combination with carboplatin plus pemetrexed or the investigator's choice of nivolumab plus ipilimumab or platinum plus pemetrexed chemotherapy for participants with epithelioid histology, and nivolumab plus ipilumab for participants with non-epithelioid histology.
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)
Masking Description: This is an open-label study for the personnel at study sites; the specific treatment to be taken by a participant will be assigned using an Interactive Response Technology/Randomization and Trial Supply Management. To maintain the integrity of the study, AstraZeneca personnel directly involved in the study conduct will not undertake or have access to efficacy data aggregated by treatment arm prior to final data readout for the primary endpoint.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Volrustomig + Carboplatin + pemetrexed	Volrustomig in combination with carboplatin plus pemetrexed	Drug: Volrustomig MEDI5752: Administered as IV infusion Other names: MEDI5752 Drug: Pemetrexed Alimta: Administered as IV infusion Other names: Alimta Drug: Carboplatin Paraplatin: Administered as IV infusion Other names: Paraplatin
Active Comparator Investigator's choice of standard care	The investigator's choice of nivolumab plus ipilimumab or platinum plus pemetrexed chemotherapy for participants with epithelioid histology, and nivolumab plus ipilumab for participants with non-epithelioid histology.	Drug: Pemetrexed Alimta: Administered as IV infusion Other names: Alimta Drug: Carboplatin Paraplatin: Administered as IV infusion Other names: Paraplatin Drug: Cisplatin Platinol: Administered as IV infusion Other names: Platinol Drug: Nivolumab Opdivo: Administered as IV infusion Other names: Opdivo Drug: Ipilimumab Yervoy: Administered as IV infusion Other names: Yervoy

Recruiting Locations

Research Site
Santa Rosa 5393287, California 5332921 95403

Research Site
Aurora 5412347, Colorado 5417618 80045

Research Site
Jacksonville 4160021, Florida 4155751 32224

Research Site
Atlanta 4180439, Georgia 4197000 30322

Research Site
Chicago 4887398, Illinois 4896861 60637

Research Site
Baltimore 4347778, Maryland 4361885 21231

Research Site
Rochester 5043473, Minnesota 5037779 55905

Research Site
St Louis 4407066, Missouri 4398678 63110

Research Site
Commack 5113412, New York 5128638 11725

Research Site
Valhalla 5142090, New York 5128638 10595

Research Site
Columbus 4509177, Ohio 5165418 43210

Research Site
Portland 5746545, Oregon 5744337 97213

Research Site
Portland 5746545, Oregon 5744337 97225

Research Site
Philadelphia 4560349, Pennsylvania 6254927 19104

Research Site
Houston 4699066, Texas 4736286 77030

Research Site
Fairfax 4758023, Virginia 6254928 22031

More Details

NCT ID: NCT06097728
Status: Recruiting
Sponsor: AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

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.