The Efficacy and Safety of PRTX007-003 Combined With Pembrolizumab in Resectable Stage III Melanoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dorośli w wieku 18 lat i starsi.
- •Potwierdzony czerniak skóry w III stadium, który można usunąć operacyjnie.
- •Pacjenci, którzy kwalifikują się do leczenia operacyjnego mającego na celu całkowite usunięcie nowotworu.
- •Ogólny stan zdrowia pozwalający na aktywność (skala ECOG 0-2).
- •Odpowiednia praca narządów.
- •Zgoda pacjenta na udział w badaniu.
✗ Disqualifies
- •Wcześniejsze leczenie czerniaka, w tym leki wzmacniające odporność.
- •Czerniak oka lub błon śluzowych.
- •Czynne choroby autoimmunologiczne wymagające leczenia.
- •Kobiety w ciąży lub karmiące piersią.
- •Niedawne leczenie innym badanym lekiem.
- •Stan, który według lekarza prowadzącego mógłby przeszkodzić w badaniu.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 19, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (7)
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
Trial contact
Gunjan Mody
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/31/2026.
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