- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04040231
Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma
August 1, 2023 updated by: Memorial Sloan Kettering Cancer Center
Combining a WT1 Cancer Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1-Expressing Malignant Pleural Mesothelioma: A Phase I Study
The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge
-
Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
-
-
New York
-
Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Center @ Commack
-
Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
-
New York, New York, United States, 10021
- Memorial Sloan - Kettering Cancer Center
-
Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Malignant Pleural Mesothelioma (MPM)
Participants with previously treated Malignant Pleural Mesothelioma/MPM
|
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.
Participants will receive nivolumab and the galinpepimut-S vaccine over 16 weeks in the initial treatment phase.
All participants will receive Sargramostim (GM-CSF) 70 mcg injected subcutaneously on days 0 and -2 of each cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose
Time Frame: 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.
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marjorie Zauderer, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 24, 2019
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
July 29, 2019
First Submitted That Met QC Criteria
July 29, 2019
First Posted (Actual)
July 31, 2019
Study Record Updates
Last Update Posted (Actual)
August 2, 2023
Last Update Submitted That Met QC Criteria
August 1, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Genetic Diseases, Inborn
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Kidney Neoplasms
- Lung Neoplasms
- Neoplastic Syndromes, Hereditary
- Neoplasms, Complex and Mixed
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Mesothelioma
- Mesothelioma, Malignant
- Wilms Tumor
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Nivolumab
- Sargramostim
Other Study ID Numbers
- 17-654
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mesothelioma
-
University of ChicagoNational Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Peritoneal Malignant Mesothelioma | Pleural Biphasic Mesothelioma | Pleural Epithelioid Mesothelioma | Pleural Malignant Mesothelioma | Pleural Sarcomatoid Mesothelioma | Recurrent Peritoneal Malignant Mesothelioma | Recurrent Pleural Malignant Mesothelioma and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Stage IA Malignant Mesothelioma | Stage IB Malignant Mesothelioma | Stage II Malignant Mesothelioma | Stage III Malignant Mesothelioma | Stage IV Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)TerminatedEpithelioid Mesothelioma | Sarcomatoid Mesothelioma | Stage IV Pleural Mesothelioma | Recurrent Malignant Mesothelioma | Stage II Pleural Mesothelioma | Stage III Pleural MesotheliomaUnited States
-
National Cancer Institute (NCI)CompletedCediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By SurgeryRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Localized Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Localized Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Stage III Pleural Malignant Mesothelioma AJCC v7 | Stage I Pleural Malignant Mesothelioma AJCC v7 | Stage IA Pleural Malignant Mesothelioma AJCC v7 | Stage IB Pleural Malignant Mesothelioma AJCC v7 | Stage II Pleural Malignant Mesothelioma AJCC...United States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Stage IA Malignant Mesothelioma | Stage IB Malignant Mesothelioma | Stage II Malignant Mesothelioma | Stage III Malignant Mesothelioma | Stage IV Malignant MesotheliomaUnited States
-
ProgenaBiomeRecruitingMesothelioma | Mesotheliomas Pleural | Mesothelioma Peritoneum | Mesothelioma Malignant | Mesothelioma; Lung | Mesothelioma; Liver | Mesothelioma; OmentumUnited States
-
National Cancer Institute (NCI)Active, not recruitingEpithelioid Mesothelioma | Pleural Malignant Mesothelioma | Sarcomatoid Mesothelioma | Recurrent Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous MesotheliomaUnited States
Clinical Trials on Galinpepimut-S
-
Sellas Life Sciences GroupAvailableAcute Myeloid Leukemia | Myelodysplastic Syndromes
-
Sellas Life Sciences GroupMerck Sharp & Dohme LLC; Cancer Insight, LLCActive, not recruitingColorectal Cancer | Ovarian Cancer | Acute Myelogenous Leukemia | Small-cell Lung Cancer | Triple-negative Breast CancerUnited States
-
Sellas Life Sciences GroupUnknownMultiple Myeloma | Minimal Residual Disease | High-Risk CancerUnited States
-
Shiga UniversityUniversity of Chicago; Shionogi; Tokyo University; Showa University; Fukushima Medical... and other collaboratorsUnknown
-
New York UniversityNational Institute of Dental and Craniofacial Research (NIDCR)Completed
-
Boston Scientific CorporationCompletedTachycardia, VentricularUnited Kingdom, Denmark, Italy, New Zealand, Germany, France, Netherlands, Portugal, Czechia, Spain
-
University Hospital, ToulouseCompleted
-
ShionogiCompletedHead and Neck Cancer | Esophageal Cancer | Lung Cancer | Mesothelioma | Bladder CancerUnited Kingdom
-
NestléCompletedStool CompositionPhilippines
-
Assiut UniversityUnknownBreastfeeding, Exclusive