Combination treatment for advanced pleural mesothelioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

+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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.