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

Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04040231
• Other study ID #: 17-654
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 24, 2019
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant
• Pleural Mesothelioma
• Wilms Tumor

Intervention

Biological:
• Galinpepimut-S
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.

Drug:
• Nivolumab
Participants will receive nivolumab and the galinpepimut-S vaccine over 16 weeks in the initial treatment phase.

Biological:
• Sargramostim
All participants will receive Sargramostim (GM-CSF) 70 mcg injected subcutaneously on days 0 and -2 of each cycle

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	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 Monmouth	Middletown	New Jersey
United States	Memorial Sloan - Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center