Clincosm LogoSign in Get a demo

Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04040231
Collaborator
(none)
10
Enrollment
6
Locations
1
Arm
47.2
Anticipated Duration (Months)
1.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
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 :
Jul 24, 2019
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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 Names:
  • GM-CSF

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum tolerated dose [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memoral Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
    2 Memoral Sloan Kettering Monmouth Middletown New Jersey United States 07748
    3 Memorial Sloan Kettering Cancer Center @ Commack Commack New York United States 11725
    4 Memorial Sloan Kettering Westchester Harrison New York United States 10604
    5 Memorial Sloan - Kettering Cancer Center New York New York United States 10021
    6 Memorial Sloan Kettering Nassau Uniondale New York United States 11553

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Principal Investigator: Marjorie Zauderer, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04040231
    Other Study ID Numbers:
    • 17-654
    First Posted:
    Jul 31, 2019
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Mesothelioma
    Mesothelioma, Malignant
    Wilms Tumor
    Nivolumab
    Sargramostim

    Study Results

    No Results Posted as of Dec 8, 2021