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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04040231
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE July 29, 2019
First Posted Date  ICMJE July 31, 2019
Last Update Posted Date July 31, 2019
Actual Study Start Date  ICMJE July 24, 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma
Official Title  ICMJE Combining a WT1 Cancer Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1-Expressing Malignant Pleural Mesothelioma: A Phase I Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mesothelioma
  • Pleural Mesothelioma
  • Wilms Tumor
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Malignant Pleural Mesothelioma (MPM)
Participants with previously treated Malignant Pleural Mesothelioma/MPM
  • Biological: Galinpepimut-S
  • Drug: Nivolumab
  • Biological: Sargramostim
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 29, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marjorie Zauderer, MD 646-888-4656
Contact: W. Victoria Lai, MD 646-449-1983
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04040231
Other Study ID Numbers  ICMJE 17-654
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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 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:
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marjorie Zauderer, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP