On May 7, 2018 Provectus reported the completion of enrollment of 24 patients with metastatic melanoma into the Phase 1b portion of the Company’s Phase 1b/2 study of intralesional ("IL") PV-10 in combination with KEYTRUDA (pembrolizumab), Merck & Co.’s systemic anti-PD-1 (programmed death receptor-1) antibody (ClinicalTrials.gov identifier: NCT02557321) (Press release, Provectus Pharmaceuticals, MAY 7, 2018, View Source [SID1234526176]). This study’s endpoints include those currently suitable for a registration trial.
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Provectus also plans to present comprehensive Phase 1b data in the first half of 2019.
Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com) ("Provectus" or the "Company") is a clinical-stage biotechnology company developing PV-10 as the first small molecule oncolytic immunotherapy for solid tumor cancers.
About PV-10
Provectus’ lead investigational oncology drug product, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.
About our Phase 1b/2 Study of PV-10 + KEYTRUDA for Metastatic Melanoma
Patients with metastatic melanoma having at least one injectable cutaneous or soft tissue lesion were eligible for participation in the Phase 1b portion of the study and received the combination of IL PV-10 and KEYTRUDA every three weeks for up to five cycles (i.e., for up to 12 weeks, with no further PV-10 administered after week 12), followed by only KEYTRUDA every three weeks for up to 24 months. The primary endpoint for the Phase 1b trial is safety and tolerability. Objective response rate and progression-free survival are key secondary endpoints; both are assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter.