Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma

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.

Conditions

• Peritoneal Malignant Mesothelioma

Interventions

BIOLOGICAL

Atezolizumab

Given IV

BIOLOGICAL

Bevacizumab

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood and tissue sample collection

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Cytoreductive Surgery

Undergo surgery

DRUG

Hyperthermic Intraperitoneal Chemotherapy

Undergo HIPEC

DRUG

Pemetrexed

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET scan

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Aaron S Mansfield · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-22

Primary Completion

2026-08-20

Completion

2026-08-20

FDA Drug

Yes

Countries

• United States

Study Locations