Active Not RecruitingPhase 1NCT04162015

A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

This study will test whether giving nivolumab in combination with pemetrexed and either cisplatin or carboplatin before surgery is a safe and effective approach to treating resectable mesothelioma without delaying surgery.

Checked against the public recordLast updated Sep 12, 2025 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1
U.S. locations7
SponsorMemorial Sloan Kettering Cancer Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Memorial Sloan Kettering Cancer Center
Interventions being studied
Drug: Nivolumab; Drug: Pemetrexed; Drug: Cisplatin or Carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memoiral Sloan Kettering Basking RidgeBasking Ridge, New Jersey
  • Memorial Sloan Kettering MonmouthMiddletown, New Jersey
  • Memorial Sloan Kettering BergenMontvale, New Jersey
  • Memorial Sloan Kettering CommackCommack, New York
  • Memorial Sloan Kettering WestchesterHarrison, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Memorial Sloan Kettering NassauUniondale, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 12, 2025. Always confirm current availability with the study team.

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