RecruitingPhase 2NCT05001880

Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma

Phase 2 Randomized Trial of Neoadjuvant or Palliative Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma


Sponsor

National Cancer Institute (NCI)

Enrollment

66 participants

Start Date

Mar 22, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding immunotherapy (a drug that activates the immune system to fight cancer) to standard chemotherapy improves survival for people whose colorectal cancer has spread to the lining of the abdomen (called peritoneal metastases). **You may be eligible if...** - You have colorectal cancer that has spread to the peritoneum (the lining of the abdomen) - You are otherwise medically fit to receive chemotherapy - You do not have uncontrolled infections, uncontrolled diabetes, or major heart problems - If you have HIV, it must be well-controlled on treatment with an undetectable viral load **You may NOT be eligible if...** - You have a serious psychiatric illness that prevents you from giving consent - You have uncontrolled infections or medical conditions making chemotherapy unsafe - Your HIV or hepatitis B/C is not well-controlled Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAtezolizumab

Given IV

BIOLOGICALBevacizumab

Given IV

PROCEDUREBiospecimen Collection

Undergo blood and tissue sample collection

DRUGCarboplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDURECytoreductive Surgery

Undergo surgery

DRUGHyperthermic Intraperitoneal Chemotherapy

Undergo HIPEC

DRUGPemetrexed

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET scan


Locations(40)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Alliance for Clinical Trials in Oncology

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

The Carle Foundation Hospital

Urbana, Illinois, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Sanford Cancer Center Worthington

Worthington, Minnesota, United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

MD Anderson in The Woodlands

Conroe, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

MD Anderson West Houston

Houston, Texas, United States

MD Anderson League City

League City, Texas, United States

MD Anderson in Sugar Land

Sugar Land, Texas, United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05001880