Study on Pembrolizumab With or Without Anetumab Ravtansine for Treating Mesothelin-Positive Pleural Mesothelioma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03126630
This clinical trial is exploring the effects of pembrolizumab, with or without anetumab ravtansine, in treating patients with mesothelin-positive pleural mesothelioma. The study aims to determine if the combination of these drugs is more effective than pembrolizumab alone.
Patient Parameters
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Program Overview
This study is testing a treatment for pleural mesothelioma, a type of cancer affecting the lining of the lungs. The treatment involves pembrolizumab, an immunotherapy drug that helps the immune system fight cancer, and anetumab ravtansine, a targeted therapy that delivers chemotherapy directly to cancer cells. Researchers want to see if using both drugs together works better than using pembrolizumab alone.
Description
The study has two main parts:
- Phase I: Researchers will find a safe dose of anetumab ravtansine to use with pembrolizumab.
- Phase II: They will compare the effectiveness of the combination treatment to pembrolizumab alone.
Secondary Goals include:
- Checking how long patients live without the cancer getting worse.
- Studying how the drugs affect certain proteins and cells in the body.
- Monitoring for any side effects or immune reactions.
Study Design:
- Group I: Patients receive pembrolizumab every 21 days for up to 24 months, unless the cancer progresses or side effects become too severe.
- Group II: Patients receive both anetumab ravtansine and pembrolizumab every 21 days, with anetumab for up to 12 months and pembrolizumab for up to 24 months, unless the cancer progresses or side effects become too severe.
After treatment, patients will be followed for 12 months to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed pleural mesothelioma.
- Willing to provide a tissue sample to test for mesothelin.
- Have received platinum-based chemotherapy.
- For Phase II: Must have measurable disease as defined by specific medical criteria.
- Tissue sample must show mesothelin expression in at least 30% of tumor cells.
- Must have good overall health with specific blood counts and organ function within normal limits.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
- Must be able to understand and sign a consent form, or have a legal representative if decision-making is impaired.
Exclusion Criteria
- Have received monoclonal antibody therapy within 4 weeks before the study.
- Have not recovered from side effects of previous cancer treatments.
- Are taking other investigational drugs.
- Have untreated or unstable brain metastases.
- Have allergies to similar drugs.
- Are taking medications that affect the liver enzyme CYP3A4.
- Have uncontrolled illnesses or infections.
- Are pregnant or breastfeeding.
- Have certain viral infections like HIV or hepatitis.
- Have other active cancers or serious lung conditions.
- Have received certain immune therapies before.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC Norris Oncology/Hematology-Newport Beach | 92663 | Newport Beach | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| UM Sylvester Comprehensive Cancer Center at Aventura | 33180 | Aventura | Florida |
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