Provectus Biopharmaceuticals, Inc. a biopharmaceutical company specializing in developing oncology and dermatology therapies, recently announced that a new Phase 3 international FDA comparative clinical study of PV-10 in melanoma treatment has begun patient enrollment.
The clinical trial is an open-label, international, multicenter, randomized controlled trial that is assessing the use of single-agent intralesional PV-10 versus dacarbazine (DTIC) or temozolomide (TMZ) to evaluate treatment of locally advanced cutaneous melanoma in patients who are BRAF V600 wild-type and who are not eligible for at least one immune checkpoint inhibitor.
PV-10, is a novel drug for cancer, designed for injection into solid tumors (intralesional administration) to reduce overall potential for systemic adverse side events.
Patients will be randomized using a 2:1 treatment allocation (i.e. two-thirds of the subjects will receive PV-10). Subjects in the comparison study group will receive either temozolomide or dacarbazine treatment, which will be determined by researcher’s preference and/or local availability of the agent. Effectiveness of the treatment will be evaluated by comparing the progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment groups. PFS will be assessed every 3 months for up to a period of time of 18 months.
The trial secondary endpoints are the complete response rate (CRR) and its duration (which will be examined for every 3 months for up to a period of 18 months); and the Overall survival (OS), which will be evaluated every 3 months for up to a period of 18 months.
An interim analysis of safety and efficacy will be performed by an independent review committee (IRC) when 50% of the events required for the primary endpoint have occurred. The researchers will monitor the duration, frequency, attribution and severity of side effects and will evaluate changes in vital signs and laboratory values to determine the safety and tolerability of PV-10.
More information about the study can be found at https://www.clinicaltrials.gov/ct2/show/NCT02288897