Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma
The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.
Checked against the public recordLast updated May 13, 2025 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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 Exclusion 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.
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.