NCT04040231CompletedPhase 1
Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma
Combining a WT1 Cancer Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1-Expressing Malignant Pleural Mesothelioma: A Phase I Study
Source: ClinicalTrials.gov · Last updated 13 May 2025
Brief summary (registry, in English)
The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 29 Jul 2019
- Start date
- 24 Jul 2019
- Primary completion date
- 14 Nov 2024
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Mesothelioma, Kidney cancer, Lung cancer
- NCT number
- NCT04040231
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 24 Jul 2019 to the primary completion date, 14 Nov 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior receipt of checkpoint inhibition
- 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
Other illness
- 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)
- Patients with active pneumonitis
Lab values
- Hematologic parameters: Absolute neutrophil count \>/= 1000/mcL
- Platelet count \<100,000
Other
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center - Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Nassau Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.