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

Conditions

• Biphasic Mesothelioma
• Epithelioid Mesothelioma
• Stage I Pleural Diffuse Malignant Mesothelioma AJCC v7
• Stage IA Pleural Diffuse Malignant Mesothelioma AJCC v7
• Stage IB Pleural Diffuse Malignant Mesothelioma AJCC v7
• Stage II Pleural Diffuse Malignant Mesothelioma AJCC v7
• Stage III Pleural Diffuse Malignant Mesothelioma AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Extrapleural Pneumonectomy — PROCEDURE
  Undergo EPP
• Pemetrexed Disodium — DRUG
  Given IV
• Pleurectomy — PROCEDURE
  Undergo PD
• Radiation Therapy — RADIATION
  Undergo RT

Study Details

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.

Key Dates

Start date

Jul 16, 2018

Status verified

Mar 2026

Primary completion

Oct 1, 2022

Completion

Sep 18, 2026

Study Design

Enrollment

28 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (chemotherapy, surgery, RT)
  NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity. SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo EPP or PD. Patients who undergo EPP will then undergo RT. MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.

Primary Outcome Measure

Feasibility of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy. [ Time Frame: 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). ]

Locations (176)

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