MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma (eVOLVE-Meso)

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Unresectable Pleural Mesothelioma

Treatments: Drug: Nivolumab; Drug: Ipilimumab; Drug: Cisplatin; Drug: Pemetrexed; Drug: Volrustomig; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06097728

2023-503231-17-00 (Registry Identifier)

D7988C00001

2023-000067-32 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 825 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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825 participants in 2 patient groups

Volrustomig + Carboplatin + pemetrexed

Experimental group

Description:

Volrustomig in combination with carboplatin plus pemetrexed

Treatment:

Drug: Carboplatin

Drug: Volrustomig

Drug: Pemetrexed

Investigator's choice of standard care

Active Comparator group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: Pemetrexed

Drug: Ipilimumab

Drug: Cisplatin

Drug: Nivolumab