Chemotherapy + Immunotherapy for Mesothelioma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had prior systemic therapy for peritoneal mesothelioma, and you should not use NSAIDs like ibuprofen around the time of pemetrexed administration if your creatinine clearance is between 45 and 79 mL/min. Also, you should not be on immunosuppressive medication within 2 weeks before starting the trial, except for certain low-dose or specific medications. It's best to discuss your current medications with the trial team.
What safety data is available for the chemotherapy and immunotherapy treatment for mesothelioma?
The safety data for the chemotherapy treatment involving pemetrexed (Alimta) combined with cisplatin or carboplatin for malignant pleural mesothelioma includes several adverse events. Pemetrexed causes myelosuppression, with common side effects such as neutropenia, fatigue, leukopenia, nausea, dyspnea, and vomiting. Additional reported toxicities include scleroderma-like changes in the lower legs and urticarial vasculitis. Patients are advised to take oral folic acid and vitamin B12 injections to reduce severe toxicities, and corticosteroids to minimize skin rashes. The treatment has been evaluated in various studies, including a phase III trial and an International Expanded Access Program, which provided safety and efficacy data for over 3000 patients.12345
Is the drug combination of Carboplatin and Pemetrexed promising for treating mesothelioma?
Yes, the combination of Carboplatin and Pemetrexed is promising for treating mesothelioma. Studies show that this drug combination can be effective and well-tolerated, with some patients experiencing significant positive responses. It is considered a feasible alternative to other standard treatments.16789
What data supports the idea that Chemotherapy + Immunotherapy for Mesothelioma is an effective treatment?
The available research shows that combining pemetrexed with cisplatin, which are part of the chemotherapy regimen, is more effective than using cisplatin alone for treating mesothelioma. In a large study, patients who received both pemetrexed and cisplatin lived longer on average (12.1 months) compared to those who received only cisplatin (9.3 months). Additionally, the combination treatment improved the quality of life and lung function for patients. This suggests that the chemotherapy part of the Chemotherapy + Immunotherapy treatment is effective for mesothelioma.1231011
Who Is on the Research Team?
Aaron S Mansfield, MD
Principal Investigator
Alliance for Clinical Trials in Oncology
Are You a Good Fit for This Trial?
Adults with untreated malignant peritoneal mesothelioma, without a history of central nervous system disease, significant bleeding disorders, or severe heart conditions. They must have functioning major organs and no autoimmune diseases (with some exceptions like controlled thyroid issues). Women must not be pregnant or nursing and agree to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive chemotherapy with or without immunotherapy every 21 days for up to 4 cycles, followed by surgery and HIPEC if eligible
Maintenance Therapy
Patients not eligible for surgery may receive maintenance therapy every 21 days in the absence of disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Bevacizumab
- Carboplatin
- Pemetrexed
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor