RecruitingPhase 2NCT07565285

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

A Phase 2 Study to Investigate the Activity of Neoadjuvant PRTX007 Combined With Pembrolizumab in Participants With Stage III Melanoma (INFLECTION-003)

Sponsor

Primmune Therapeutics, Inc.

Enrollment

48 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Melanoma Stage III

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PRTX007 and a drug called Pembrolizumab for people with melanoma stage iii. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPRTX007

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)

DRUGPembrolizumab

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