ClinicalTrials.gg
RecruitingNCT06057935Updated Sep 24, 2026

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

A Phase 2 interventional study of Pemetrexed and Cisplatin in Malignant Peritoneal Mesothelioma, Peritoneal Mesothelioma and Mesothelioma, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Primary conditionMesothelioma, MalignantRegistry: MesotheliomaReclassifiedWhy we changed it
Registry
Mesothelioma — the first condition term the registry derived for this study.
ClinicalTrials.gg
Mesothelioma, Malignant
Why
  1. The study's listed conditions name Mesothelioma, Malignant, a narrower term within Mesothelioma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies testing pemetrexed in Mesothelioma, Malignant — 1 open to participants now, 3 under way, none of them phase 3. Pemetrexed · Mesothelioma, Malignant.

Planned enrollment
5th of 17
64 · median 28
Started
2023
the only one that year
Phase 2
10 of 18
1 open now
Registered
18th of 18
by date
Lead sponsor
3 of 18
Memorial Sloan Kettering Cancer Center

Among the 18 studies testing pemetrexed in Mesothelioma, Malignant, this one is the 5th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2023, is one of 10 in phase 2, and was the 18th registered.

Mesothelioma, Malignant

339 studies on the registry are indexed under Mesothelioma, Malignant; 64 are open to participants now.

This study's planned enrollment of 64 is above the median of 39 across 271 interventional studies indexed under Mesothelioma, Malignant.

Browse Mesothelioma, Malignant studies →

Open to participants now

1 of the 18 studies testing pemetrexed in Mesothelioma, Malignant is open now, in 1 country. Each count lists the studies.

About pemetrexed

Pemetrexed: first FDA approval 2004 (ALIMTA), first EMA approval 2004. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 55 Mesothelioma, Malignant studies recruiting now, 43 (78%) set no upper age limit and 5 (9%) stop at 75 or younger; 2 take children under 18; 3 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 18 studies testing pemetrexed in Mesothelioma, Malignant, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Malignant Peritoneal Mesothelioma
  • Peritoneal Mesothelioma
  • Mesothelioma
  • Mesothelioma, Malignant
  • Malignant Mesothelioma

Browse trials for

Keywords

  • Malignant Peritoneal Mesothelioma
  • Peritoneal Mesothelioma
  • Mesothelioma
  • Mesothelioma, Malignant
  • Malignant Mesothelioma
  • ICARuS II
  • Memorial Sloan Kettering Cancer Center
  • 23-145
04

In context

Mesothelioma, Malignant Reclassified

339 studies on the registry are indexed under Mesothelioma, Malignant; 64 are open to participants now.

This study's planned enrollment of 64 is above the median of 39 across 271 interventional studies indexed under Mesothelioma, Malignant.

Browse Mesothelioma, Malignant studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Compared within Mesothelioma, Malignant, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mesothelioma. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • performance status ≤ 1.
  • Hematology: ≥ 1,500/µl.
  • > 75,000/µl.
  • Adequate renal function: creatinine \< 1.5× the (ULN) or calculated of ≥50 ml/min.
  • Adequate hepatic function: \< 1.5 mg/dl (except in patients with Gilbert's syndrome, who must have total bilirubin \< 3.0 mg/dL).
  • Women of with a negative pregnancy test result (urine or blood) who agree to use an effective 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 to participate in this clinical trial must be obtained prior to any study procedure.

Exclusion criteria

Exclusion Criteria:

  • Subjects who have previously undergone intraperitoneal chemotherapy or systemic chemotherapy/immunotherapy for peritoneal mesothelioma.
  • Subjects who have previously received platinum-containing chemotherapy regimens.
  • Subjects with preoperative or intraoperative consistent with sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma.
  • Other prior , 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 .
  • 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.
  • (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.
  • \< 12 weeks.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

06

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (estimated)

Study 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.

    Drug: Pemetrexed · Drug: Cisplatin · Drug: Carboplatin

  • 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.

    Drug: Pemetrexed · Drug: Cisplatin · Drug: Carboplatin

Interventions

  • Pemetrexed will be administered intravenously

  • Cisplatin will be administered intravenously

  • Possible substitution with carboplatin based on clinician discretion

07

What researchers measure

Primary outcomes

  1. Progression Free Survival

    Progression Free Survival in the two treatment arms.

    Time frame: up to 24 months

08

Study locations

9 of 13 sites recruiting
  • University of Chicago (Data Collection Only)
    Chicago, Illinois 60637, United States
    Recruiting
    • Hedy Kindler, MD · Contact773-702-1470
  • University of Michigan (Data Collection Only)
    Ann Arbor, Michigan 48109, United States
    Not yet recruiting
    • Donnele Daley, MD · Contact734-647-8902
  • Washington University (Data Collection Only)
    St Louis, Missouri 63110, United States
    Not yet recruiting
    • Trang Nguyen, MD · Contact314-362-2280
  • University of Nebraska (Data collection only)
    Omaha, Nebraska 68198-7680, United States
    Not yet recruiting
    • Jason Foster, MD · Contact402-559-8941
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
    Recruiting
    • Garrett Nash, MD, MPH · Contact212-639-8668
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Garrett Nash, MD · Contact212-639-8668
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    Montvale, New Jersey 07645, United States
    Recruiting
    • Garrett Nash, MD · Contact212-639-8668
  • Rutgers University (Data Collection Only)
    New Brunswick, New Jersey 08903, United States
    Not yet recruiting
    • H. Richard Alexander, MD · Contact732-235-6780
  • Memorial Sloan Kettering Commack (Limited Protocol Activities)
    Commack, New York 11725, United States
    Recruiting
    • Garrett Nash, MD · Contact212-639-8668
  • Memorial Sloan Kettering Westchester (Limited Protocol Activites)
    Harrison, New York 10604, United States
    Recruiting
    • Garrett Nash, MD · Contact212-639-8668
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    New York, New York 10065, United States
    Recruiting
    • Garrett Nash, MD · Contact212-639-8668
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
    Uniondale, New York 11553, United States
    Recruiting
    • Garrett Nash, MD · Contact212-639-8668
  • Allegheny Health Network (Data Collection Only)
    Pittsburgh, Pennsylvania 15212, United States
    Recruiting
    • Patrick Wagner, MD · Contact833-246-7662
09

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Sep 2028, 60 months after the start.

Of 41 non-industry phase 2 interventional studies under Mesothelioma, Malignant, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 100. This study's planned 60 months is below that.

Counting every sponsor, half of 48 studies reached it within 48 months; a quarter within 29 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2023
First posted
Sep 28, 2023
StartActual
Sep 21, 2023
Primary completionEst.
Sep 21, 2028
CompletionEst.
Sep 21, 2028
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06057935
Responsible party
Sponsor
First posted
Sep 28, 2023
Start date
Sep 21, 2023
Primary completion
Sep 21, 2028 (estimated)
Completion
Sep 21, 2028 (estimated)
Last update
Sep 24, 2026

Study contacts

Garrett Nash, MD
Contact
nashg@mskcc.org
212-639-8668
Michael Offin, MD
Contact
offinm@mskcc.org
646-608-3763
Garrett Nash, MD
principal investigator · Memorial Sloan Kettering Cancer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Pemetrexed · Cisplatin · Carboplatin

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