ORL

TITRE Étude internationale de phase III, multicentrique, sans insu et à répartition aléatoire visant à évaluer le volrustomig comme traitement séquentiel comparativement à l’observation chez des participants atteints d’un carcinome épidermoïde de la tête et du cou localement avancé et non réséqué qui n’a pas progressé après une chimioradiothérapie concomitante définitive.
PROTOCOLE ID eVOLVE-HNSCC
CLINICAL TRIAL.gov ID NCT06129864
TYPE(S) DE CANCER ORL
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Nathaniel Bouganim
COORDONATEUR(RICE) Julie Latreille
julie.latreille@muhc.mcgill.ca
514-934-1934 poste 38945
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).
  • Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).
  • Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent within 12 weeks prior to randomization.
CRITÈRES D'EXCLUSION (EN)
  • Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with >1 primary tumors are not eligible for the study.

  • Participants with any of the following:

    • Residual disease that needs further treatment with curative intent after definitive cCRT administration;
    • LA-HNSCC that was resected before definitive cCRT
    • LA-HNSCC that was treated and is recurrent at the time of screening
  • Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.
  • Receipt of the last dose of anticancer therapy (chemotherapy and/or RT) > 12 weeks (84 days) prior to randomization.