Provectus Opens Phase 3 Trial Enrollment for Investigational Melanoma Agent

Thursday, April 16, 2015 | Personnel/Company News , Phase 3/4 Trials , Skin Cancer

Provectus Biopharmaceuticals, Inc. has opened enrollment of patients for its phase 3 international FDA comparative clinical trial of PV-10 for melanoma. The study is an international multicenter, open-label, randomized controlled trial of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine or temozolomide to assess treatment of locally advanced cutaneous melanoma in patients who are BRAF V600 wild-type and have failed or are not otherwise candidates for ipilimumab or another immune checkpoint inhibitor. Patients in the comparator arm will receive the Investigator's choice of dacarbazine or temozolomide as determined by Investigator preference and/or local availability of the agent. Effectiveness will be assessed by comparison of progression-free survival between all intent-to-treat subjects in the two study treatment arms. The Primary Outcome Measure is progression-free survival to be assessed every 12 weeks up to 18 months.

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