Vessie/urothélial

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  • PIVOT-006

TITRE (EN) A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec Versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
PROTOCOLE ID PIVOT-006
CLINICAL TRIAL.gov ID NCT06111235
TYPE(S) DE CANCER Vessie/urothélial
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CUSM
1001 boul. Décarie
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Wassim Kassouf
COORDONATEUR(RICE) Karla Jauregui Sanchez
karla.jaureguisanchez@muhc.mcgill.ca
514-934-1934 poste 34905
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)

  • Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:

    • Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor
    • Solitary LG Ta >3 cm tumor
    • Multifocal LG Ta tumors
    • Primary and solitary HG Ta ≤3 cm tumor
    • LG T1 tumor
  • All visible disease removed by TURBT within 12 weeks of study randomization
  • Acceptable baseline organ function
CRITÈRES D'EXCLUSION (EN)
  • High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta>3cm tumor(s), CIS)
  • Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor)
  • Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization
  • Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer
  • Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Ad-interferon or Adstiladrin)