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

27 de abril de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

48

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Medicamento: 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)
Medicamento: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Major Pathologic Response (MPR) Rate
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-Related AEs (irAEs), and Dose-Limiting Toxicities (DLTs)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Primmune Therapeutics, Inc.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de maio de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de junho de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

20 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de abril de 2026

Primeira postagem (Real)

4 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • PRTX007-003

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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