Mélanome

TITRE Étude clinique de phase 3, randomisée, à double insu, contrôlée par placebo et comparateur actif, portant sur le V940 (ARNm-4157) adjuvant et le pembrolizumab par rapport au placebo adjuvant et au pembrolizumab chez des participants atteints d’un mélanome de stade II à IV à haut risque
PROTOCOLE ID V940-001
CLINICAL TRIAL.gov ID NCT05933577
TYPE(S) DE CANCER Mélanome
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
VILLE Québec
INVESTIGATEUR(RICE) PRINCIPAL(E) Joël Claveau
COORDONATEUR(RICE) Mélanie Bradley
melanie.bradley@mail.chuq.qc.ca
418-525-4444 poste 12950
STATUT  Fermé
CRITÈRES D'ÉLIGIBILITÉ (EN)

The main inclusion criteria include but are not limited to the following:

  • Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma
  • Has not received any prior systemic therapy for their melanoma beyond surgical resection
  • No more than 13 weeks have passed between final surgical resection and the first dose of pembrolizumab
  • Is disease free at the time of providing documented consent for the study
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
CRITÈRES D'EXCLUSION (EN)

The main exclusion criteria include but are not limited to the following:

  • Has ocular or mucosal melanoma
  • Has past or current cancer that has spread to other parts of the body
  • Has heart failure within the past 6 months
  • Has received prior cancer therapy or another cancer vaccine
  • Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years
  • Has severe reaction to study medications or any of their substance used to prepare a drug
  • Have not recovered from major surgery or have ongoing surgical complications