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

NCT04040231

Description:

The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.

Related Conditions:
  • Malignant Pleural Mesothelioma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 17-654
  • NCT ID: NCT04040231

Conditions

  • Mesothelioma
  • Pleural Mesothelioma
  • Wilms Tumor

Interventions

DrugSynonymsArms
Galinpepimut-SMalignant Pleural Mesothelioma (MPM)
NivolumabMalignant Pleural Mesothelioma (MPM)
SargramostimGM-CSFMalignant Pleural Mesothelioma (MPM)

Purpose

The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.

Trial Arms

NameTypeDescriptionInterventions
Malignant Pleural Mesothelioma (MPM)ExperimentalParticipants with previously treated Malignant Pleural Mesothelioma/MPM
  • Galinpepimut-S
  • Nivolumab
  • Sargramostim

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

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose
Time Frame:up to 24 months
Safety Issue:
Description:A dose will be considered tolerable if there are no more than 2 out of 10 participants with dose limiting toxicities.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Mesothelioma
  • Pleural Mesothelioma
  • Wilms Tumor Protein 1
  • WT1
  • galinpepimut-S
  • Montanide
  • Nivolumab
  • Phase I
  • 17-654
  • Memorial Sloan Kettering Cancer Center

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