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

Phase 1

Completed

• Conditions: Pleural Mesothelioma; Wilms Tumor; Mesothelioma
• Interventions: Biological: Galinpepimut-S; Drug: Nivolumab; Biological: Sargramostim

• Registration Number: NCT04040231
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-24
• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Status Verified: 2024-11
• Primary Completion: 2024-11-14
• Study Completion: 2024-11-14
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Malignant Pleural Mesothelioma (MPM)	Galinpepimut-S	Participants with previously treated Malignant Pleural Mesothelioma/MPM
Malignant Pleural Mesothelioma (MPM)	Sargramostim	Participants with previously treated Malignant Pleural Mesothelioma/MPM
Malignant Pleural Mesothelioma (MPM)	Nivolumab	Participants with previously treated Malignant Pleural Mesothelioma/MPM

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	up to 24 months	A dose will be considered tolerable if there are no more than 2 out of 10 participants with dose limiting toxicities.

Trial Locations

Locations (6)

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan - Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States