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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 actualizado 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

48

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Major Pathologic Response (MPR) Rate
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-Related AEs (irAEs), and Dose-Limiting Toxicities (DLTs)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Primmune Therapeutics, Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de mayo de 2026

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de junio de 2029

Fechas de registro del estudio

Enviado por primera vez

20 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de abril de 2026

Publicado por primera vez (Actual)

4 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PRTX007-003

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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