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A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma

ICARuS II (Intraperitoneal Chemotherapy After cytoReductive Surgery): A Multicenter, Randomized Phase II Trial of Normothermic Intraperitoneal Chemotherapy and Intravenous Chemotherapy After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Malignant Peritoneal Mesothelioma

NCT06057935•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out whether intraperitoneal or intravenous chemotherapy given after cytoreductive surgery and HIPEC are effective treatments for people with malignant peritoneal mesothelioma. Outcomes will be compared by observing intraperitoneal versus intravenous treatments to analyze if one is better than the other.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient age 18 years or older, both sexes.
•Clinical diagnosis of MPM at enrolling institution.
•Prior to randomization, intraoperative pathologic confirmation of epithelioid MPM at enrolling institution.
•Complete or near-complete CRS achieved.
•Patient must be planning to undergo complete cytoreduction of all peritoneal disease.
•ECOG performance status ≤ 1.
•Hematology: ANC ≥ 1,500/µl.
•Platelets \> 75,000/µl.
•Adequate renal function: creatinine \< 1.5× the upper limit of normal (ULN) or calculated creatinine clearance of ≥50 ml/min.
•Adequate hepatic function: bilirubin \< 1.5 mg/dl (except in patients with Gilbert's syndrome, who must have total bilirubin \< 3.0 mg/dL).
+3 more criteria

Exclusion Criteria

•Subjects who have previously undergone intraperitoneal chemotherapy or systemic chemotherapy for peritoneal mesothelioma.
•Subjects who have previously received platinum-containing chemotherapy regimens.
•Subjects with preoperative or intraoperative biopsy consistent with sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma.
•Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than three years, or indolent tumors for which observation over two years is a reasonable option.
•High suspicion for extra-abdominal metastases.
•Women who are pregnant or lactating.
•Active coronary artery disease (defined as unstable angina or a positive cardiac stress test). Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 60 days of enrollment or are determined by a cardiologist to be of acceptable perioperative risk.
•Uncontrolled hypertension defined as \>140/90 and not cleared for surgery at the time of consent.
•New York Heart Association (NYHA) Class II or higher congestive heart failure; restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
•History of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
+6 more criteria

Locations (13)

University of Chicago (Data Collection Only)

Chicago, Illinois, United States

University of Michigan (Data Collection Only)

Ann Arbor, Michigan, United States

Washington University (Data Collection Only)

St Louis, Missouri, United States

University of Nebraska (Data collection only)

Omaha, Nebraska, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Rutgers University (Data Collection Only)

New Brunswick, New Jersey, United States

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activites)

Harrison, New York, United States

Key Dates

Start Date

September 21, 2023

Primary Completion Date

September 21, 2028

Completion Date

September 21, 2028

Last Updated

July 22, 2025

Enrollment

ESTIMATED participants

Conditions

Malignant Peritoneal MesotheliomaPeritoneal MesotheliomaMesotheliomaMesothelioma, MalignantMalignant Mesothelioma

Interventions

Pemetrexed

DRUG

Cisplatin

DRUG

Carboplatin

DRUG

Contacts

Garrett Nash, MD

CONTACT

212-639-8668 nashg@mskcc.org

Michael Offin, MD

CONTACT

646-608-3763 offinm@mskcc.org

A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

NCT06051695

Solid Tumor, AdultColorectal Cancer+18 more

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RECRUITINGPHASE1

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

NCT06885697

MesotheliomaNeoplasms+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

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