DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma

Conditions

• Malignant Pleural Mesothelioma
• Mesothelioma
• Pleural Mesothelioma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
• Standard Chemotherapy — DRUG
  Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks) for 4 to 6 cycles, followed by Observation
• Ipilimumab and Nivolumab — DRUG
  Ipilimumab 1 mg/kg every 6 weeks and Nivolumab 360 mg every 3 weeks or 3 mg/kg every 2 weeks for up to 2 years

Study Details

Patients with pleural mesothelioma (PM) that cannot be surgically removed will receive standard chemotherapy (cisplatin or carboplatin and pemetrexed) given with durvalumab, a type of immunotherapy, or a treatment chosen by the study doctor, which is either standard chemotherapy or immunotherapy combination (ipilimumab and nivolumab). Durvalumab is an antibody (a type of human protein) that works by blocking a body substance called Programmed Death-Ligand 1 (PD-L1). Blocking PD-L1 helps the body's immune system attack cancer cells. Research has shown that durvalumab can slow tumor growth and shrink tumors in some people with cancer. Previous studies of combining durvalumab and chemotherapy showed that this combination is active in advanced mesothelioma. The purpose of this study is to see whether adding durvalumab to standard chemotherapy will improve overall survival (OS) in patients with PM.

Key Dates

Start date

Feb 18, 2021

Status verified

Jan 2026

Primary completion

Jun 20, 2025

Completion

Jun 30, 2025

Study Design

Enrollment

214 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Arm: Durvalumab + Chemotherapy, then Durvalumab Maintenance
  Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
• Active Comparator: Control Arm: Chemotherapy, then Observation
  Standard Chemotherapy for 4 to 6 cycles, followed by Observation
• Active Comparator: Control Arm: Ipilimumab and Nivolumab
  Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.

Primary Outcome Measure

Effects on Overall Survival [ Time Frame: Minimum follow-up is 24 months after randomisation. ]

Locations (25)

Related coverage on Hipa.ai

• Nivolumab Phase 3 Trial for Advanced Pleural Mesothelioma Completes Primary…
  Nivolumab · Jun 20, 2025 · ClinicalTrials.gov

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