PRTX007 plus pembrolizumab before surgery for melanoma that can be removed
Tests PRTX007 with pembrolizumab before surgery in adults with melanoma.
Plain-language title generated from the registry record
Registry title: The Efficacy and Safety of PRTX007-003 Combined With Pembrolizumab in Resectable Stage III Melanoma
Key facts
- Where
- Cairns, Greenslopes, Melbourne, Nedlands, Waratah, and Woolloongabba, AustraliaSee the 7 sites
- Phase
- Phase 2
Where in Australia
- Cairns and Hinterland Hospital and Health ServiceCairns, AustraliaNot yet recruiting
- Gallipoli Medical ResearchGreenslopes, AustraliaNot yet recruiting
- Peter MacCallum Cancer CentreMelbourne, AustraliaTaking people
- One Clinical Research Pty LtdNedlands, AustraliaTaking people
- Sir Charles Gairdner HospitalNedlands, AustraliaNot yet recruiting
- Calvary Mater NewcastleWaratah, AustraliaTaking people
- Princess Alexandra HospitalWoolloongabba, AustraliaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Primmune Therapeutics, Inc.
- Trial code
- NCT07565285
- Record updated
- 23 October 2026
- Original description
This Phase 2, multi-center, single-arm study evaluates the safety, tolerability, and activity of neoadjuvant PRTX007 in combination with pembrolizumab in participants with resectable Stage III melanoma. Neoadjuvant immunotherapy has demonstrated improved clinical outcomes compared with adjuvant-only approaches, but there remains a need to enhance pathologic response rates without significant added toxicity.Read full original descriptionShow less
A Phase 2 Study to Investigate the Activity of Neoadjuvant PRTX007 Combined With Pembrolizumab in Participants With Stage III Melanoma (INFLECTION-003)
This Phase 2, multi-center, single-arm study evaluates the safety, tolerability, and activity of neoadjuvant PRTX007 in combination with pembrolizumab in participants with resectable Stage III melanoma. Neoadjuvant immunotherapy has demonstrated improved clinical outcomes compared with adjuvant-only approaches, but there remains a need to enhance pathologic response rates without significant added toxicity.
Participants will receive oral PRTX007, a Toll-like receptor 7 (TLR7) agonist prodrug, administered in combination with intravenous pembrolizumab prior to surgical resection. The primary objective is to determine the major pathologic response (MPR) rate following neoadjuvant therapy. Secondary objectives include evaluation of safety, pathologic complete response, event-free survival, overall survival, pharmacokinetics, and immune-related biomarkers.
This study aims to determine whether the addition of PRTX007 to pembrolizumab improves antitumor immune responses and clinical outcomes in patients with Stage III melanoma.
Inclusion: Adults aged 18 years or older; Histologically confirmed, resectable Stage III cutaneous melanoma; Candidate for curative-intent surgical resection; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Adequate organ function; Able to provide written informed consent.
Exclusion: Prior systemic therapy for melanoma, including immunotherapy; Primary immunodeficiency or use of systemic immunosuppressive therapy; Recent treatment with another investigational therapy; Active autoimmune disease requiring systemic treatment; Any condition that, in the opinion of the investigator, would interfere with study participation or safety; Uveal melanoma or mucosal melanoma; Women who are pregnant or breastfeeding.