RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Primmune Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07565285

Registry updated: 2026-08-19

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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. 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.

Interventions

PRTX007 (Drug)
PRTX007 is an orally administered prodrug of PRX034, a Toll-like receptor 7 (TLR7) agonist designed to activate innate and adaptive immune responses. NEOADJUVANT REGIMEN * 600 mg orally once daily (safety run-in participants) or * 750 mg orally once daily (subsequent participants) * Administered 3 days on, 4 days off (7-day cycle) * Total of 9 cycles (9 weeks) ADJUVANT REGIMEN (IF NO MPR) * 750 mg orally once daily * Administered 3 days on, 4 days off * Total of 12 cycles (12 weeks)
Pembrolizumab (Drug)
Pembrolizumab is a programmed cell death protein-1 (PD-1) blocking antibody administered by intravenous infusion NEOADJUVANT REGIMEN * 200 mg IV every 3 weeks (Q3W) * Total of 3 cycles (9 weeks) ADJUVANT REGIMEN * 400 mg IV every 6 weeks (Q6W) for 7 cycles OR * 200 mg IV every 3 weeks (Q3W) for 14 cycles * Total duration: approximately 42 weeks

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

Conditions

Melanoma Stage III

Locations

Calvary Mater Newcastle — Waratah, New South Wales, Australia
Cairns And Hinterland Hospital And Health Service — Cairns, Queensland, Australia
Gallipoli Medical Research — Greenslopes, Queensland, Australia
Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
One Clinical Research Pty Ltd — Nedlands, Western Australia, Australia
Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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