Groupe d'Etude en Oncologie du Quebec

Title	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
ClinicalTrials.gov ID	NCT06111235
Cancer Type(s)	Bladder/urothelial
Phase	Phase III
Stage
Study Type	Clinical
Drug	Cretostimogene Grenadenorepvec Versus Observation
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 1001 boul. Décarie , Montréal, QC, H4A 3J1
City
Principal Investigator	Dr. Wassim Kassouf
Coordinator	Karla Jauregui Sanchez 514-934-1934
Status	Recruiting
Activation Date	10-06-2024
Eligibility Criteria	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
Exclusion Criteria	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)

Groupe d'étude en oncologie du Québec