Study on MEDI5752 with Carboplatin and Pemetrexed for Unresectable Pleural Mesothelioma
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06097728
This clinical trial is testing a new treatment combination of MEDI5752, Carboplatin, and Pemetrexed to see if it is effective and safe for patients with pleural mesothelioma that cannot be removed by surgery. The study compares this combination to other standard treatments.
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Program Overview
The purpose of this study is to evaluate the effectiveness and safety of a new treatment combination involving MEDI5752, Carboplatin, and Pemetrexed for patients with pleural mesothelioma that cannot be surgically removed. Participants will be randomly assigned to receive either the new treatment or one of the standard treatments, which include a combination of platinum and Pemetrexed or Nivolumab and Ipilimumab.
Description
This study is for adults diagnosed with pleural mesothelioma, a type of cancer affecting the lining of the lungs, which cannot be removed by surgery. Participants will be randomly divided into two groups. One group will receive the new treatment combination of MEDI5752, Carboplatin, and Pemetrexed. The other group will receive a standard treatment chosen by the study doctor, which could be either a combination of platinum and Pemetrexed or Nivolumab and Ipilimumab. The study aims to determine which treatment is more effective and safer for patients.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of pleural mesothelioma with known type (epithelioid or non-epithelioid).
- The cancer must be advanced and cannot be removed by surgery.
- Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have measurable cancer according to specific medical criteria.
- Have adequate bone marrow and organ function as determined by medical tests.
Exclusion Criteria
- Any condition that might interfere with the study or affect the safety of the participant, as judged by the study doctor.
- Have active or previously documented autoimmune or inflammatory disorders.
- Have a history of another primary cancer, with some exceptions.
- Have uncontrolled illnesses.
- Have infections like tuberculosis, hepatitis B or C, or HIV that are not well controlled.
- Be receiving any other cancer treatments, including chemotherapy, radiotherapy, or investigational therapies.
- Have untreated or worsening cancer that has spread to the brain or central nervous system.
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