New drug cocktail aims to shrink mesothelioma before surgery
NCT ID NCT04162015
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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22 people
The number who actually took part.
- Started
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Nov 2019
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memoiral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a pill that blocks multiple cancer proteins shrink Hard-to-Treat tumors?
- Triple-Drug cocktail targets Hard-to-Treat mesothelioma
- New antibody-chemo combo shows promise for mesothelioma
- Triple threat: new combo tackles rare lung cancer
- Immunotherapy before surgery shows promise for mesothelioma patients