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
1 other identifier
interventional
10
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2019
Longer than P75 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 24, 2019
CompletedFirst Submitted
Initial submission to the registry
July 29, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2024
CompletedMay 13, 2025
November 1, 2024
5.3 years
July 29, 2019
May 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Malignant Pleural Mesothelioma (MPM)
EXPERIMENTALParticipants with previously treated Malignant Pleural Mesothelioma/MPM
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Offin, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2019
First Posted
July 31, 2019
Study Start
July 24, 2019
Primary Completion
November 14, 2024
Study Completion
November 14, 2024
Last Updated
May 13, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
• 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.