This is a multicenter, Phase II, open-label, 42-patient single-arm trial of intratumoral
pIL-12 electroporation (EP) in combination with pembrolizumab in patients with melanoma.
Patients will be evaluated in 2 parts. Part A patients will be selected using a flow
cytometric assay that quantifies intratumoral PD-1hiCD8+CTLA4+ "exhausted" lymphocytes in the
tumor. Part B will enroll patients who have or are failing pembrolizumab at least 12 weeks
after starting Programmed cell death protein 1 (PD-1) antibody alone or in combination, or,
who have been selected using a flow cytometric assay that quantifies intratumoral
PD-1hiCD8+CTLA4+ "exhausted" lymphocytes in the tumor.
Phase:
Phase 2
Details
Lead Sponsor:
Alain Algazi University of California, San Francisco
Collaborators:
Merck Sharp & Dohme Corp. OncoSec Medical Incorporated