Mesothelioma, Pleural Mesothelioma, Wilms Tumor
Conditions
Keywords
Mesothelioma, Pleural Mesothelioma, Wilms Tumor Protein 1, WT1, galinpepimut-S, Montanide, Nivolumab, Phase I, 17-654, 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.
Interventions
BIOLOGICALGalinpepimut-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.
DRUGNivolumab
Participants will receive nivolumab and the galinpepimut-S vaccine over 16 weeks in the initial treatment phase.
BIOLOGICALSargramostim
All participants will receive Sargramostim (GM-CSF) 70 mcg injected subcutaneously on days 0 and -2 of each cycle
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed