Recruiting

Phase 2

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

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06057935

Conditions

Malignant Peritoneal Mesothelioma

Peritoneal Mesothelioma

Mesothelioma

Mesothelioma, Malignant

Malignant Mesothelioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pemetrexed

Cisplatin

Carboplatin

Study Details

Brief 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.

Conditions

Malignant Peritoneal Mesothelioma

Peritoneal Mesothelioma

Mesothelioma

Mesothelioma, Malignant

Malignant Mesothelioma

Study ID

NCT06057935

Start date

Sep 21, 2023

Status verified date

Jul, 2026

Completion date

Sep 21, 2028

Anticipated

Primary completion date

Sep 21, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).
Women of childbearing potential with a negative pregnancy test result (urine or blood) who agree to use an effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
A man participating in this study must agree to utilize a reliable barrier form of contraception for the duration of the study
Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.

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.
Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or place them at an unacceptable risk for participation in the study.
Patients with known cisplatin, carboplatin, pemetrexed or mitomycin allergy.
Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.
Any condition that would preclude the ability to deliver appropriate IP therapy.
Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator.
Life expectancy < 12 weeks.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IVC arm

Pemetrexed and cisplatin will be administered intravenously for a total of 4 to 6 cycles. Participants will receive 4 cycles, but can receive up to 6 cycles based on clinician discretion. Substitution with carboplatin allowed for pre-existing impairment of hearing, renal function, or neuropathy.

active comparator: NIPC arm

After completion of hyperthermic intraperitoneal chemotherapy/HIPEC, an intraperitoneal catheter with a subcutaneous reservoir will be inserted through the abdominal wall. When the participant's condition is considered stable by the physicians, the NIPC will be started. Pemetrexed and either cisplatin or carboplatin will be administered through the intraperitoneal port.

Interventions

Pemetrexed

Pemetrexed will be administered intravenously

Cisplatin

Cisplatin will be administered intravenously

Carboplatin

Possible substitution with carboplatin based on clinician discretion

Primary outcome measure

Progression Free Survival [ Time Frame: up to 24 months ]

Central Contacts and Locations

Central contacts

Garrett Nash, MD

212-639-8668 nashg@mskcc.org

Michael Offin, MD

646-608-3763 offinm@mskcc.org

Locations

University of Chicago (Data Collection Only)

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Hedy Kindler, MD

773-702-1470

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Garrett Nash, MD, MPH

212-639-8668

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Garrett Nash, MD

212-639-8668

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Garrett Nash, MD

212-639-8668

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Garrett Nash, MD

212-639-8668

Memorial Sloan Kettering Westchester (Limited Protocol Activites)

Recruiting

Harrison, New York, United States, 10604

Contacts

Garrett Nash, MD

212-639-8668

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Garrett Nash, MD

212-639-8668

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Garrett Nash, MD

212-639-8668

Allegheny Health Network (Data Collection Only)

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Patrick Wagner, MD

833-246-7662

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

Malignant Peritoneal Mesothelioma
Peritoneal Mesothelioma
Mesothelioma
Mesothelioma, Malignant
Malignant Mesothelioma
ICARuS II
Memorial Sloan Kettering Cancer Center
23-145

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-21.