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CompletedPhase 1NCT04040231
Official study title

Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma

Study summary

The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGalinpepimut-S and Nivolumab

Plus 1 other study approaches.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 13, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

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
Biological: Galinpepimut-S; Drug: Nivolumab; Biological: Sargramostim
02
Explore related studies

How this study is categorized

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

Cancer type
Mesothelioma→
Treatment approach
Immunotherapy→Cell or gene therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Age \>/= 18 years
  • Karnofsky performance status \>/= 70%
  • Pathologic diagnosis of malignant pleural mesothelioma at MSK
  • Positive immunohistochemical staining for WT-1 within 60 days of treatment start
  • Patients must have received at least one prior course of pemetrexed-based chemotherapy
  • Patients of childbearing potential must have a negative serum pregnancy test within 24 hours of receiving the first treatment on the study (if female) and must be practicing an effective form of birth control for the entire duration of treatment (both females and males)
  • Has received and progressed or are refractory to pemetrexed based chemotherapy
  • Measurable or evaluable disease
  • Biochemical parameters: Total bilirubin \< 1.5 mg/dl, AST and ALT \< 3.0 x upper limits of normal, Creatinine \< 1.5 x upper limits of normal
Reasons someone may not be able to joinExclusion criteria
  • Pregnant or lactating women
  • Prior receipt of checkpoint inhibition
  • Patients with known active hepatitis B or known active hepatitis C virus
  • Patients with a serious unstable medical illness or another active cancer
  • Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Autoimmune disease requiring treatment with systemic steroids in the past 2 years
  • Current use of systemic corticosteroids at doses greater than prednisone 10 mg daily or the equivalent
  • Patients with active pneumonitis
  • Hematologic parameters: Absolute neutrophil count \>/= 1000/mcL
  • Platelet count \<100,000

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

  • Memorial Sloan Kettering Basking RidgeBasking Ridge, New Jersey
  • Memorial Sloan Kettering MonmouthMiddletown, New Jersey
  • Memorial Sloan Kettering Cancer Center @ 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: May 13, 2025. Always confirm current availability with the study team.

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