PV-10 + Pembrolizumab for Melanoma

Overview

PV-10 is an investigational new drug containing a proprietary injectable formulation of rose bengal disodium, a water-soluble xanthene dye currently in use in a topical opthalmic diagnostic. PV-10 is designed for injection into solid tumors (intralesional administration). Its oncology focus is on melanoma, breast cancer and cancers of the liver. Provectus has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications.

Status

  • A Phase 1b/2 trial is currently in progress.
  • Over 270 cancer patients have been treated with PV-10, including 12 in a Phase 1 recurrent breast cancer study, 6 in a Phase 1 metastatic liver cancer study, 20 in a Phase 1 melanoma study, 80 in a Phase 2 melanoma study, 10 in an investigator-initiated study of PV-10 chemoablation followed by radiotherapy, and over 140 patients enrolled in the Compassionate Use Program for PV-10. Additionally, 11 of the 80 Phase 2 melanoma study subjects continued with the Compassionate Use Program.

Phase 1b/2 Clinical Trial

  • In January 2016 it was announced that the first patients had been dosed.
  • A Phase 1b/2 study (ClinicalTrials.gov ID: NCT02557321) was initiated in September 2015 to evaluate the safety and tolerability of combining PV-10 and pembrolizumab for the treatment of melanoma in stage IV patients in a Phase 1b portion of the study, and to assess efficacy of the combination in a Stage 2 portion.

    Primary Outcome Measures:

    • Safety and tolerability of the combination regimen assessed by adverse events (AEs) [ Time Frame: Start of treatment until 4 weeks after final administration of PV-10.]

      Phase 1b: Safety and tolerability of the combination regimen will be assessed by monitoring the frequency, duration, severity and attribution of adverse events (AEs) and toxicities requiring discontinuation of study treatment, and evaluating changes in laboratory values and vital signs.
    • Progression Free Survival (PFS) [ Time Frame: Up to 24 months from initiation of study treatment ]

      Phase 2: Response evaluated by blinded independent review committee assessment per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

    Secondary Outcome Measures

    • Progression Free Survival (PFS) [ Time Frame: Up to 24 months from initiation of study treatment ]
      Phase 1b: Response evaluated per RECIST 1.1
    • Objective Response Rate (ORR) [ Time Frame: Up to 24 months from initiation of study treatment ]
      Phase 1b and 2: Response evaluated per RECIST 1.1
    • Change in immune biomarkers [ Time Frame: Up to 28 weeks from initiation of study treatment ]
      Phase 1b and 2: Peripheral Blood Mononuclear Cells (PBMCs) assessed vs. baseline values for changes in T cell populations
    • Overall Survival (OS) [ Time Frame: 24 months from initiation of study treatment for last subject randomized ]
      Phase 1b and 2
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