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1 Study Matches

A Multicenter Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid (tavo, pIL-12) plus Electroporation in Combination with Intravenous Pembrolizumab in Patients with Stage III/IV Melanoma who are Progressing on either Pembrolizumab or Nivolumab Treatment (PISCES)

The purpose of this voluntary research study is to find out what effects, good and/or bad, the combination of a type of gene therapy treatment called plasmid electroporation and pembrolizumab has on your cancer.
Irina Geier at or 717-531-8678
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Pathologically documented unresectable melanoma, American Joint Committee on Cancer (AJCC) version 8, Stage III or IV
Subjects must be refractory to anti-PD-1 monoclonal antibodies (pembrolizumab or nivolumab either as monotherapy or in combination with other approved checkpoint inhibitors or targeted therapies according to their approved label
Resolution/improvement of anti-PD1 mAb-related AEs (including immune related AEs; irAEs) back to Grade 0-1
BRAF V600 mutation-positive melanoma could have received standard of care targeted therapy for advanced or metastatic disease
Has a performance status of 0 or 1 on the ECOG Performance Scale
Exclusion Criteria:
Subject has disease that is suitable for local therapy administered with curative intent
Clinically active CNS metastases
Subject with a diagnosis of uveal melanoma
Subject who had an allogenic tissue/solid organ transplant
Subjects with electronic pacemakers or defibrillators
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Hershey, PA