PRTX007-003 with pembrolizumab before surgery for stage III melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, multicenter, open-label, single-arm trial conducted in Australia evaluating neoadjuvant PRTX007 in combination with pembrolizumab for resectable stage III melanoma. The primary goal is to measure the major pathologic response after neoadjuvant therapy, with secondary aims including safety, pathologic complete response, event-free survival, overall survival, pharmacokinetics, and immune biomarkers. Part A includes a dose-escalation safety run-in (3+3 design) to establish tolerability, followed by Part B to enroll additional participants based on observed activity. After neoadjuvant treatment, patients undergo surgical resection; post-surgical therapy is response-adapted based on MPR status. The study uses oral PRTX007 dosing cycles with intravenous pembrolizumab for three cycles prior to surgery and continues with adjuvant strategies depending on response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Prior systemic therapy for melanoma, including immunotherapy
* Uveal melanoma or mucosal melanoma.
* Active autoimmune disease requiring systemic treatment
* Primary immunodeficiency or use of systemic immunosuppressive therapy
* Women who are pregnant or breastfeeding
* Recent treatment with another investigational therapy
* Any condition that, in the opinion of the investigator, would interfere with study participation or safety

Where it's running

• Calvary Mater Newcastle
  Waratah, New South Wales, Australia Recruiting
• Peter MacCallum Cancer Centre
  Melbourne, Victoria, Australia Recruiting
• One Clinical Research Pty Ltd
  Nedlands, Western Australia, Australia Recruiting
• Cairns And Hinterland Hospital And Health Service
  Cairns, Queensland, Australia Not yet recruiting
• Gallipoli Medical Research
  Greenslopes, Queensland, Australia Not yet recruiting
• Princess Alexandra Hospital
  Woolloongabba, Queensland, Australia Not yet recruiting

Study contacts

• Study coordinator: Gunjan Mody
• Email: gunjan.mody@novotech-cro.com
• Phone: +61 2 9199 9596

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.