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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
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mesothelioma Pleural Mesothelioma Wilms Tumor Biological: Galinpepimut-S Drug: Nivolumab Biological: Sargramostim Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Marjorie Zauderer, MD 646-888-4656 zauderem@mskcc.org
Contact: W. Victoria Lai, MD 646-449-1983 laiw@mskcc.org

Locations
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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      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Marjorie Zauderer, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:
Memorial Sloan Kettering Cancer Center  This link exits the ClinicalTrials.gov site

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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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Mesothelioma
Pleural Mesothelioma
Wilms Tumor Protein 1
WT1
galinpepimut-S
 Montanide
Nivolumab
Phase I
17-654
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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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