ClinicalTrials.Veeva

Menu

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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Active, not recruiting
Phase 1

Conditions

Pleural Mesothelioma
Wilms Tumor
Mesothelioma

Treatments

Biological: Sargramostim
Biological: Galinpepimut-S
Drug: Nivolumab

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Malignant Pleural Mesothelioma (MPM)
Experimental group
Description:
Participants with previously treated Malignant Pleural Mesothelioma/MPM
Treatment:
Drug: Nivolumab
Biological: Galinpepimut-S
Biological: Sargramostim

Trial contacts and locations

6

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems