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

17 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Geschat)

48

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Australië
    • New South Wales
      • Waratah, New South Wales, Australië, 2298
        • Werving
        • Calvary Mater Newcastle
    • Queensland
      • Cairns, Queensland, Australië, 4870
        • Nog niet aan het werven
        • Cairns And Hinterland Hospital And Health Service
      • Greenslopes, Queensland, Australië, 4120
        • Nog niet aan het werven
        • Gallipoli Medical Research
      • Woolloongabba, Queensland, Australië, 4102
        • Nog niet aan het werven
        • Princess Alexandra Hospital
    • Victoria
      • Melbourne, Victoria, Australië, 3000
        • Nog niet aan het werven
        • Peter MacCallum Cancer Centre
    • Western Australia
      • Nedlands, Western Australia, Australië, 6009
        • Nog niet aan het werven
        • Sir Charles Gairdner Hospital
      • Nedlands, Western Australia, Australië, 6009
        • Werving
        • One Clinical Research Pty Ltd

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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)
Geneesmiddel: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Major Pathologic Response (MPR) Rate
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-Related AEs (irAEs), and Dose-Limiting Toxicities (DLTs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Primmune Therapeutics, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 juni 2029

Studieregistratiedata

Eerst ingediend

20 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 april 2026

Eerst geplaatst (Werkelijk)

4 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

17 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PRTX007-003

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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