Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma
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ClinicalTrials.gov Identifier: NCT04040231 |
Recruitment Status :
Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mesothelioma Pleural Mesothelioma Wilms Tumor | Biological: Galinpepimut-S Drug: Nivolumab Biological: Sargramostim | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | July 24, 2019 |
Estimated Primary Completion Date : | July 2020 |
Estimated Study Completion Date : | July 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Malignant Pleural Mesothelioma (MPM)
Participants with previously treated Malignant Pleural Mesothelioma/MPM
|
Biological: Galinpepimut-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. Drug: Nivolumab Participants will receive nivolumab and the galinpepimut-S vaccine over 16 weeks in the initial treatment phase. Biological: Sargramostim All participants will receive Sargramostim (GM-CSF) 70 mcg injected subcutaneously on days 0 and -2 of each cycle
Other Name: GM-CSF |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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
- 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)
- Adequate archival or fresh tissue for correlative analyses within 60 days prior to starting treatment as long as there was no interval cancer-directed therapy
- If sufficient archival or fresh tissue is not available, then a repeat biopsy at baseline prior to starting study treatment will be required
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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040231
Contact: Marjorie Zauderer, MD | 646-888-4656 | zauderem@mskcc.org | |
Contact: W. Victoria Lai, MD | 646-449-1983 | laiw@mskcc.org |
United States, New Jersey | |
Memoral Sloan Kettering Basking Ridge | Recruiting |
Basking Ridge, New Jersey, United States, 07920 | |
Contact: Marjorie Zauderer, MD 646-888-4656 | |
Memoral Sloan Kettering Monmouth | Recruiting |
Middletown, New Jersey, United States, 07748 | |
Contact: Marjorie Zauderer, MD 646-888-4656 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center @ Commack | Recruiting |
Commack, New York, United States, 11725 | |
Contact: Marjorie Zauderer, MD 646-888-4656 | |
Memorial Sloan Kettering West Harrison | Recruiting |
Harrison, New York, United States, 10604 | |
Contact: Marjorie Zauderer, MD 646-888-4656 | |
Memorial Sloan - Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Marjorie Zauderer, MD 646-888-4656 | |
Memorial Sloan Kettering Nassau | Recruiting |
Uniondale, New York, United States, 11553 | |
Contact: Marjorie Zauderer, MD 646-888-4656 |
Principal Investigator: | Marjorie Zauderer, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT04040231 History of Changes |
Other Study ID Numbers: |
17-654 |
First Posted: | July 31, 2019 Key Record Dates |
Last Update Posted: | July 31, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Mesothelioma Pleural Mesothelioma Wilms Tumor Protein 1 WT1 galinpepimut-S |
Montanide Nivolumab Phase I 17-654 Memorial Sloan Kettering Cancer Center |
Wilms Tumor Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Neoplasms by Site Neoplasms, Complex and Mixed Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplastic Syndromes, Hereditary Vaccines |
Mesothelioma Adenoma Kidney Diseases Urologic Diseases Genetic Diseases, Inborn Nivolumab Sargramostim Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological Antineoplastic Agents |