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DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma

NCT04334759 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2026-01-22

No results posted yet for this study

Summary

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.

Conditions

  • Mesothelioma
  • Pleural Mesothelioma
  • Malignant Pleural Mesothelioma

Interventions

DRUG

Durvalumab

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

DRUG

Standard Chemotherapy

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

DRUG

Ipilimumab and Nivolumab

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Thoracic Oncology Group Australasia (TOGA)

    collaborator UNKNOWN

  • University of Sydney

    collaborator OTHER

  • PrECOG, LLC.

    lead OTHER

Principal Investigators

  • Patrick Forde, MD · Johns Hopkins University

  • Anna Nowak, MD · Faculty of Health and Medical Sciences University of Western Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-18
Primary Completion
2025-06-20
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04334759 on ClinicalTrials.gov