Conducted in the US at the University of California San Francisco, the University of Washington and the John Wayne Cancer Institute, the single-arm, open-label study will assess the local and distant response subsequent to treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation.
A maximum dose of 1.5mg DNA IL-12 will be applied thrice to around four lesions on days 1, 5 and 8 in one treatment cycle of the study.
The primary endpoint is overall objective response as measured by modified RECIST at six months, while secondary endpoints include safety and tolerability, in addition to local response of treated lesions at day 90.
OncoSec Medical president and CEO Punit Dhillon said the enrolment of advanced-stage melanoma patients in phase II clinical marks a significant adoption of ImmunoPulse.
"We are now interested in directing the focus to data analysis and the design of our next studies for the melanoma program, including expanding the adoption across other key centers of excellence," Dhillon added.
The subjects will be assessed for safety for up to five years up on the shift to follow-up phase of the study at 12 months.
The company expects final data from the multicentre trial in six to 12 months.