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

RecruitingPhase 2Ages 18 Years - anyAllPrimmune Therapeutics, Inc.
NCT07565285 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 whet

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📋 Eligibility rules (as published)
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
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What it tests

  • PRTX007
  • Pembrolizumab
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Where

7 sites
Calvary Mater Newcastle
Waratah, Australia
Cairns And Hinterland Hospital And Health Service
Cairns, Australia
Gallipoli Medical Research
Greenslopes, Australia
Princess Alexandra Hospital
Woolloongabba, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
One Clinical Research Pty Ltd
Nedlands, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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