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

27 aprile 2026 aggiornato da: Primmune Therapeutics, Inc.

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study investigates whether combining the TLR7 agonist PRTX007 with pembrolizumab enhances immune-mediated tumor response in the neoadjuvant setting for Stage III melanoma, with the goal of improving pathologic response rates and clinical outcomes while maintaining an acceptable safety profile.

Design This is a Phase 2, multi-center, open-label, single-arm study conducted in Australia. The study will enroll approximately 48 participants with resectable Stage III melanoma.

The study consists of two parts:

  • Part A: 24 participants will be enrolled, including an initial dose-escalation safety run-in using a 3+3 design to evaluate tolerability and dose-limiting toxicities.
  • Part B: An additional 24 participants will be enrolled if sufficient activity is observed in Part A.

Treatment Plan

Participants will receive neoadjuvant therapy consisting of:

  • PRTX007: Oral administration for 3 days on and 4 days off per week for 9 cycles (7-day cycles)
  • Pembrolizumab: 200 mg intravenous infusion every 3 weeks for 3 cycles Following completion of neoadjuvant therapy, participants will undergo definitive surgical resection.

Post-surgical treatment will be response-adapted:

  • Participants achieving MPR may receive observation or pembrolizumab alone
  • Participants without MPR will receive adjuvant PRTX007 in combination with pembrolizumab

Tipo di studio

Interventistico

Iscrizione (Stimato)

48

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Neoadjuvant PRTX007 + Pembrolizumab (Response-Adapted Adjuvant Therapy)
Participants with resectable Stage III melanoma will receive neoadjuvant treatment with PRTX007 in combination with pembrolizumab prior to definitive surgical resection. Following surgery, participants will receive response-adapted adjuvant therapy based on pathologic response. Participants achieving a major pathologic response (MPR) may receive observation or pembrolizumab alone, while participants without MPR will receive adjuvant PRTX007 in combination with pembrolizumab.
Droga: PRTX007

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)
Droga: Pembrolizumab

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Major Pathologic Response (MPR) Rate
Lasso di tempo: At time of surgical resection (approximately 9 weeks after initiation of treatment)
Major pathologic response (MPR) is defined as ≤10% residual viable tumor cells in the resected tumor specimen following completion of neoadjuvant therapy, as assessed by central pathology review.
At time of surgical resection (approximately 9 weeks after initiation of treatment)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-Related AEs (irAEs), and Dose-Limiting Toxicities (DLTs)
Lasso di tempo: From first dose of study treatment through end of study (approximately up to 52 weeks)
Number and severity of adverse events, serious adverse events, immune-related adverse events, and dose-limiting toxicities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.
From first dose of study treatment through end of study (approximately up to 52 weeks)
Number of participants with abnormal physical examination findings, abnormal vital signs, abnormal Eastern Cooperative Oncology Group (ECOG) performance status, and abnormal clinical laboratory parameters
Lasso di tempo: Baseline through end of study (approximately up to 52 weeks)
Baseline through end of study (approximately up to 52 weeks)
Pathologic Complete Response (pCR) Rate
Lasso di tempo: At time of surgical resection (approximately 9 weeks after initiation of treatment)
Pathologic complete response (pCR) is defined as the absence of residual viable tumor cells (0%) in the resected tumor specimen following neoadjuvant therapy, as assessed by central pathology review.
At time of surgical resection (approximately 9 weeks after initiation of treatment)
Event-Free Survival (EFS)
Lasso di tempo: From first dose up to 1 year
Event-free survival (EFS) is defined as the time from first dose of study treatment to any of the following events: disease progression or toxicity preventing surgery during neoadjuvant treatment; recurrence of disease after surgery; failure to achieve complete resection (R0 or R1); or death from any cause.
From first dose up to 1 year
Overall Survival (OS)
Lasso di tempo: From first dose through end of study (approximately up to 52 weeks or longer if followed)
Overall survival is defined as the time from first dose of study treatment to death from any cause.
From first dose through end of study (approximately up to 52 weeks or longer if followed)
Pharmacokinetics of PRTX007
Lasso di tempo: During treatment period (multiple time points from baseline through approximately 9 weeks and selected later time points)
Plasma concentrations of PRTX007 and its active metabolite will be measured to characterize pharmacokinetic parameters using validated analytical methods.
During treatment period (multiple time points from baseline through approximately 9 weeks and selected later time points)
Changes in cytokine, chemokine and soluble PD-1/PD-L1 biomarkers
Lasso di tempo: Baseline through treatment period (up to approximately 9 weeks and selected later time points)
Baseline through treatment period (up to approximately 9 weeks and selected later time points)
Changes in mRNA expression
Lasso di tempo: Baseline through treatment period (up to approximately 9 weeks and selected later time points)
Baseline through treatment period (up to approximately 9 weeks and selected later time points)
Changes in immune cell activation and proliferation markers
Lasso di tempo: Baseline through treatment period (up to approximately 9 weeks and selected later time points)
Baseline through treatment period (up to approximately 9 weeks and selected later time points)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Primmune Therapeutics, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 giugno 2029

Date di iscrizione allo studio

Primo inviato

20 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PRTX007-003

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared because the study involves an investigational product and the sponsor has not established a data sharing plan at this time.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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