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

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

Official Title
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Combining a WT1 Cancer Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1-Expressing Malignant Pleural Mesothelioma: A Phase I Study

Conditions
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Mesothelioma, Pleural Mesothelioma, Wilms Tumor

Intervention / Treatment
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* Biological: Galinpepimut-S
* Drug: Nivolumab
* Biological: Sargramostim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Malignant Pleural Mesothelioma (MPM)<br>Participants with previously treated Malignant Pleural Mesothelioma/MPM | Biological: Galinpepimut-S<br>* Galinpepimut-S will be administered alone on weeks 0 and 2. Participants will receive the galinpepimut-S vaccine and nivolumab over 16 weeks in the initial treatment phase.<br>Drug: Nivolumab<br>* Participants will receive nivolumab and the galinpepimut-S vaccine over 16 weeks in the initial treatment phase.<br>Biological: Sargramostim<br>* All participants will receive Sargramostim (GM-CSF) 70 mcg injected subcutaneously on days 0 and -2 of each cycle<br>* Other names: GM-CSF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose | A dose will be considered tolerable if there are no more than 2 out of 10 participants with dose limiting toxicities. | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesothelioma, Pleural Mesothelioma, Wilms Tumor Protein 1, WT1, galinpepimut-S, Montanide, Nivolumab, Phase I, 17-654, Memorial Sloan Kettering Cancer Center