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

Primary Purpose

Mesothelioma, Pleural Mesothelioma, Wilms Tumor

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Galinpepimut-S
Nivolumab
Sargramostim
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesothelioma focused on measuring Mesothelioma, Pleural Mesothelioma, Wilms Tumor Protein 1, WT1, galinpepimut-S, Montanide, Nivolumab, Phase I, 17-654, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Cancer Center @ Commack
  • Memorial Sloan Kettering Westchester
  • Memorial Sloan - Kettering Cancer Center
  • Memorial Sloan Kettering Nassau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Malignant Pleural Mesothelioma (MPM)

Arm Description

Participants with previously treated Malignant Pleural Mesothelioma/MPM

Outcomes

Primary Outcome Measures

Maximum tolerated dose
A dose will be considered tolerable if there are no more than 2 out of 10 participants with dose limiting toxicities.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2019
Last Updated
August 1, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04040231
Brief Title
Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma, Pleural Mesothelioma, Wilms Tumor
Keywords
Mesothelioma, Pleural Mesothelioma, Wilms Tumor Protein 1, WT1, galinpepimut-S, Montanide, Nivolumab, Phase I, 17-654, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Malignant Pleural Mesothelioma (MPM)
Arm Type
Experimental
Arm Description
Participants with previously treated Malignant Pleural Mesothelioma/MPM
Intervention Type
Biological
Intervention Name(s)
Galinpepimut-S
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Participants will receive nivolumab and the galinpepimut-S vaccine over 16 weeks in the initial treatment phase.
Intervention Type
Biological
Intervention Name(s)
Sargramostim
Other Intervention Name(s)
GM-CSF
Intervention Description
All participants will receive Sargramostim (GM-CSF) 70 mcg injected subcutaneously on days 0 and -2 of each cycle
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Description
A dose will be considered tolerable if there are no more than 2 out of 10 participants with dose limiting toxicities.
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjorie Zauderer, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan - Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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