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The Efficacy and Safety of PRTX007-003 Combined With Pembrolizumab in Resectable Stage III Melanoma

RecruitingPhase 2

Sponsor: Primmune Therapeutics, Inc.

Conditions: Melanoma Stage III

Interventions: PRTX007, Pembrolizumab

Countries: Australia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (7)

Waratah, New South Wales, Australia
Cairns, Queensland, Australia
Greenslopes, Queensland, Australia
Woolloongabba, Queensland, Australia
Melbourne, Victoria, Australia
Nedlands, Western Australia, Australia
Nedlands, Western Australia, Australia