Clinical trial NCT04040231: Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mesothelioma
Pleural Mesothelioma
Wilms Tumor
Keywords: Mesothelioma
Pleural Mesothelioma
Wilms Tumor Protein 1
WT1
galinpepimut-S
Montanide
Nivolumab
Phase I
17-654
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael Offin, MD
role: PRINCIPAL_INVESTIGATOR
References: