MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Conditions

• Unresectable Pleural Mesothelioma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Volrustomig — DRUG
  MEDI5752: Administered as IV infusion
• Pemetrexed — DRUG
  Alimta: Administered as IV infusion
• Carboplatin — DRUG
  Paraplatin: Administered as IV infusion
• Cisplatin — DRUG
  Platinol: Administered as IV infusion
• Nivolumab — DRUG
  Opdivo: Administered as IV infusion
• Ipilimumab — DRUG
  Yervoy: Administered as IV infusion

Study Details

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.

Key Dates

Start date

Nov 9, 2023

Status verified

Jun 2026

Primary completion

Nov 16, 2028

Completion

Nov 16, 2028

Study Design

Enrollment

861 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Volrustomig + Carboplatin + pemetrexed
  Volrustomig in combination with carboplatin plus pemetrexed
• 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.

Primary Outcome Measure

Overall Survival (OS) in experimental arm relative to comparator arm [ Time Frame: up to approximately 61 months ]

Locations (14)

Find similar trials in Santa Rosa, CA