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

Primary Outcome Measures 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. Inclusion Criteria Age >/= 18 years Karnofsky performance status >/= 70% Pathologic diagnosis of malignant pleural mesothelioma at MSK Positive immunohistochemical staining for WT-1 Patients mesothelioma/" title="Continue reading.">more

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.

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

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Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: August 9th, 2019.

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Last update: May 07, 2019. 08:38:48 pm.