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New drug cocktail aims to shrink mesothelioma before surgery

NCT ID NCT04162015

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This early study tests whether giving nivolumab (an immunotherapy) along with standard chemotherapy before surgery is safe and feasible for people with malignant pleural mesothelioma. The main goal is to see if this approach delays surgery by more than 30 days. 22 participants will receive the drug combination, then undergo surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nivolumab combined with pemetrexed and cisplatin or carboplatin
What this could lead to
If it works, this could point toward a safer way to shrink mesothelioma tumors before surgery, potentially improving outcomes.
What could go wrong
This is a very early Phase 1 trial with only 22 people. It may not work or could cause delays in surgery due to side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

22 people

The number who actually took part.

Started

Nov 2019

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Karnofsky performance status \> 70% * Pathologic diagnosis of malignant pleural mesothelioma. * Potentially resectable by pleurectomy/decortication, as assessed by thoracic surgeon * Negative serum pregnancy test in women of childbearing potential * Female patients of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 5 months after the last administration of nivolumab and at least 6 months after last administration of pemetrexed, whichever is longer * Male patients with female partners of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 7 months after the last administration of nivolumab and at least 3 months after the last administration of pemetrexed, whichever is longer * Adequate archival or fresh tissue for correlative analysis. Archival tissue will be deemed acceptable as long as their was no interval therapy prior to cycle 1 day 1 of protocol therapy. If sufficient archival or fresh tissue is not available, then a repeat biopsy at baseline prior to starting study treatment will be required as long as medically safe and feasible * Absolute neutrophil count ≥ 1000/mcL * Total bilirubin ≤ 1.5 mg/dl * AST and ALT ≤ 3.0 x upper limit of normal * Creatinine ≤ 1.5 x upper limit of normal * Negative HIV serology blood test Exclusion Criteria: * Prior treatment with chemotherapy or immunotherapy for mesothelioma * Autoimmune disease requiring systemic immune modulating treatment during the past two years * Pregnant or lactating women * Known active hepatitis B or hepatitis C * Current use of systemic prednisone at dose ≥ 10 mg daily (or the equivalent dose with another corticosteroid) * Serious concurrent medical illness or another active cancer requiring treatment * Active pneumonitis

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Conditions

The condition(s) this trial relates to.

malignant pleural mesothelioma Mesothelioma, Malignant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memoiral Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

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