Phase 2 Randomized Trial of Neoadjuvant or Palliative Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma
National Cancer Institute (NCI)
Summary
This phase II trial compares the usual treatment alone (carboplatin, pemetrexed, and bevacizumab) to using immunotherapy (atezolizumab) plus the usual treatment in treating patients with peritoneal mesothelioma. The usual treatment consists of surgery or chemotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid and may kill cancer cells. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with usual treatment may work better than usual treatment alone.
Description
PRIMARY OBJECTIVE: I. To determine whether frontline treatment with carboplatin, pemetrexed, bevacizumab and atezolizumab results in a superior best response rate than carboplatin, pemetrexed and bevacizumab in patients with peritoneal mesothelioma as determined by Response Evaluation Criteria in Solid Tumors (RECIST). SECONDARY OBJECTIVES: I. To determine the safety, major pathologic response rates, and completeness of cytoreduction of patients treated with neoadjuvant carboplatin, pemetrexed, bevacizumab and atezolizumab or carboplatin, pemetrexed and bevacizumab. II. To determine the sa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Physicians should consider whether any of the following may render the patient inappropriate for this protocol: * Psychiatric illness which would prevent the patient from giving informed consent * Medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for th…
Interventions
- BiologicalAtezolizumab
Given IV
- BiologicalBevacizumab
Given IV
- ProcedureBiospecimen Collection
Undergo blood and tissue sample collection
- DrugCarboplatin
Given IV
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureCytoreductive Surgery
Undergo surgery
- DrugHyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
Locations (40)
- Mayo Clinic Hospital in ArizonaPhoenix, Arizona
- Alliance for Clinical Trials in OncologyChicago, Illinois
- University of Chicago Comprehensive Cancer CenterChicago, Illinois
- Carle at The RiverfrontDanville, Illinois
- Carle Physician Group-EffinghamEffingham, Illinois
- Carle Physician Group-Mattoon/CharlestonMattoon, Illinois