BENITIONSClinical Trial Intelligence

Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma

Phase 1 Active, not recruiting NCT03228537

ConditionBiphasic Mesothelioma, Epithelioid Mesothelioma, Stage I Pleural Diffuse Malignant Mesothelioma AJCC v7, Stage IA Pleural Diffuse Malignant Mesothelioma AJCC v7
PhasePhase 1
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment28 participants
InterventionsAtezolizumab, Cisplatin, Extrapleural Pneumonectomy, Pemetrexed Disodium, Pleurectomy
Start dateJul 16, 2018
Completion dateOct 1, 2022
Results postedMar 5, 2024

Summary

This phase I pilot trial studies how well atezolizumab, pemetrexed disodium, cisplatin, and surgery with or without radiation therapy works in treating patients with stage I-III pleural malignant mesothelioma. 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. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab, pemetrexed disodium, and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving atezolizumab after surgery may kill any remaining tumor cells.

Feasibility of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy.

Duration of treatment until first dose of maintenance therapy. Includes 21 day cycles of neoadjuvant chemo and surgery - extrapleural pneumonectomy or pleurectomy/decortication (radiation therapy for participants who received extrapleural pneumonectomy). · Participants

Treatment (Chemotherapy, Surgery +/- RT, Maintenance)15 Participants

Safety of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy.

Duration of treatment and follow-up until death or 3 years post Step 1 registration. · Participants

Treatment (Chemotherapy, Surgery +/- RT, Maintenance)1 Participants

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