Combination treatment for advanced pleural mesothelioma
A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination With Carboplatin Plus Pemetrexed Versus Platinum Plus Pemetrexed or Nivolumab Plus Ipilimumab in Participants With Unresectable Pleural Mesothelioma (eVOLVE-Meso)
This study is testing a new combination treatment for adults with advanced pleural mesothelioma to see if it works better than the usual care options.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 825 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | chemotherapy, Nivolumab, Ipilimumab |
| Locations | 178 sites (Phoenix, Arizona and 177 other locations) |
| Trial ID | NCT06097728 on ClinicalTrials.gov |
What this trial studies
This phase III, randomized, open-label, multicenter study aims to evaluate the efficacy and safety of Volrustomig (MEDI5752) combined with Carboplatin and Pemetrexed compared to the investigator's choice of standard treatments in patients with unresectable pleural mesothelioma. Eligible participants are adults with a confirmed diagnosis of advanced unresectable pleural mesothelioma who will be randomized to receive either the experimental treatment or standard care. The study will assess treatment outcomes based on measurable disease and patient safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced unresectable pleural mesothelioma.
Not a fit: Patients with active autoimmune disorders or uncontrolled intercurrent illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced pleural mesothelioma.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating mesothelioma, indicating potential for success.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Phoenix, Arizona and 177 other locations
- Research Site — Phoenix, Arizona, United States (Withdrawn)
- Research Site — Duarte, California, United States (Withdrawn)
- Research Site — Santa Rosa, California, United States (Recruiting)
- Research Site — Aurora, Colorado, United States (Recruiting)
- Research Site — Jacksonville, Florida, United States (Recruiting)
- Research Site — Atlanta, Georgia, United States (Recruiting)
- Research Site — Chicago, Illinois, United States (Recruiting)
- Research Site — Baltimore, Maryland, United States (Recruiting)
- Research Site — Rochester, Minnesota, United States (Recruiting)
- Research Site — St Louis, Missouri, United States (Recruiting)
- Research Site — East Brunswick, New Jersey, United States (Withdrawn)
- Research Site — Commack, New York, United States (Recruiting)
- Research Site — Valhalla, New York, United States (Recruiting)
- Research Site — Cleveland, Ohio, United States (Withdrawn)
- Research Site — Cleveland, Ohio, United States (Withdrawn)
- Research Site — Cleveland, Ohio, United States (Withdrawn)
- Research Site — Columbus, Ohio, United States (Recruiting)
- Research Site — Independence, Ohio, United States (Withdrawn)
- Research Site — Portland, Oregon, United States (Recruiting)
- Research Site — Portland, Oregon, United States (Recruiting)
- Research Site — Portland, Oregon, United States (Withdrawn)
- Research Site — Philadelphia, Pennsylvania, United States (Recruiting)
- Research Site — Houston, Texas, United States (Recruiting)
- Research Site — Fairfax, Virginia, United States (Recruiting)
- Research Site — Chermside, Australia (Active_not_recruiting)
- Research Site — Clayton, Australia (Active_not_recruiting)
- Research Site — Melbourne, Australia (Active_not_recruiting)
- Research Site — Nedlands, Australia (Active_not_recruiting)
- Research Site — Westmead, Australia (Active_not_recruiting)
- Research Site — Anderlecht, Belgium (Active_not_recruiting)
- Research Site — Antwerp, Belgium (Active_not_recruiting)
- Research Site — Ghent, Belgium (Completed)
- Research Site — Hasselt, Belgium (Active_not_recruiting)
- Research Site — Leuven, Belgium (Withdrawn)
- Research Site — Sint-Niklaas, Belgium (Active_not_recruiting)
- Research Site — Barretos, Brazil (Active_not_recruiting)
- Research Site — Fortaleza, Brazil (Active_not_recruiting)
- Research Site — João Pessoa, Brazil (Withdrawn)
- Research Site — Porto Alegre, Brazil (Active_not_recruiting)
- Research Site — Rio de Janeiro, Brazil (Active_not_recruiting)
- Research Site — Santo André, Brazil (Active_not_recruiting)
- Research Site — São Paulo, Brazil (Active_not_recruiting)
- Research Site — Edmonton, Alberta, Canada (Active_not_recruiting)
- Research Site — Hamilton, Ontario, Canada (Withdrawn)
- Research Site — London, Ontario, Canada (Withdrawn)
- Research Site — Ottawa, Ontario, Canada (Active_not_recruiting)
- Research Site — Toronto, Ontario, Canada (Active_not_recruiting)
- Research Site — Montreal, Quebec, Canada (Active_not_recruiting)
- Research Site — Québec, Quebec, Canada (Active_not_recruiting)
- Research Site — Beijing, China (Active_not_recruiting)
+128 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Marjorie G Zauderer, MD — Memorial Slone Kettering (MSK) Cancer Centre
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.