Kidney Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT04040231

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 6 Locations for this study

See Locations Near You

Memorial Sloan Kettering Basking Ridge
Basking Ridge New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center @ Commack
Commack New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States
Memorial Sloan - Kettering Cancer Center
New York New York, 10021, United States
Memorial Sloan Kettering Nassau
Uniondale New York, 11553, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT04040231

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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