US-based Provectus Biopharmaceuticals has started patient enrolment in its Phase III international FDA comparative clinical trial of its new investigational drug, PV-10, for the treatment of melanoma.

The trial will involve around 225 patients and enrolment has started at the first study site, St. Luke’s University Hospital and Health Network, Bethlehem, with additional sites to be added in future.

The international multi-centre, open-label, randomised controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) will evaluate treatment of locally advanced cutaneous melanoma in patients.

The drug will be assessed in melanoma 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.

The company said that effectiveness will be evaluated by comparing progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.

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The trial’s primary outcome measure is PFS to be evaluated every 12 weeks up to 18 months, while the secondary outcome measures include complete response rate (CRR) and its duration; and overall survival (OS) to be assessed every 12 weeks up to 18 months.

In the trial, safety and tolerability will be evaluated by monitoring the frequency, duration, severity and attribution of adverse events as well as by assessing changes in laboratory values and vital signs.

The US Food and Drug Administration (FDA) has granted orphan drug designations for Provectus’ PH-10 for melanoma and hepatocellular carcinoma indications.

The company has completed Phase II trials of PV-10 as a therapy for metastatic melanoma, and of PH-10 as a topical treatment for atopic dermatitis and psoriasis.

Image: Lymph node with almost complete replacement by metastatic melanoma. Photo: courtesy of Gabriel Caponetti.