NCT03228537|Active Not RecruitingPhase 1ResultsFDA Drug

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

A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed With Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2017-01230S1619U10CA180888

Study Type

interventional

Target

Locations

1 country

Sites

176

Timeline

RegisteredJul 2017

StartedJul 2018

CompletionSep 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

5mo left

Started Jul 2018

Longer than P75 for phase_1

Geographic Reach

1 country

176 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.2 years study duration

Study Progress96%

Jul 2018Sep 2026

First Submitted

Initial submission to the registry

July 24, 2017

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed

12 months until next milestone

Study Start

First participant enrolled

July 16, 2018

Completed

4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

March 5, 2024

Completed

2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2026

Expected

Last Updated

May 1, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

July 24, 2017

Results QC Date

November 1, 2023

Last Update Submit

April 30, 2026

Conditions

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

Outcome Measures

Primary Outcomes (2)

Feasibility of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy.
The number of participants who received at least two cycles of the triplet neoadjuvant therapy getting at least one dose of 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).
Safety of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy.
The number of participants that experienced a Grade 4-5 immune-related adverse event. The regimen was considered safe if no participants experienced a Grade 4-5 immune-related AE.
Duration of treatment and follow-up until death or 3 years post Step 1 registration.

Secondary Outcomes (3)

Progression Free Survival (PFS)
Duration of treatment and follow-up until death or 3 years post Step 1 registration.
Overall Survival (OS)
3 years after the last accrual
Response Rate (RR)
Duration of treatment and follow-up until death or 3 years post Step 1 registration.

Study Arms (1)

Treatment (chemotherapy, surgery, RT)

EXPERIMENTAL

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.

Drug: AtezolizumabDrug: CisplatinProcedure: Extrapleural PneumonectomyDrug: Pemetrexed DisodiumProcedure: PleurectomyRadiation: Radiation Therapy

Interventions

AtezolizumabDRUG

Given IV

Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG 7446, RG-7446, RG7446, RO 5541267, RO-5541267, RO5541267, Tecentriq