A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

Active:	Yes
Cancer Type:	Bladder Cancer Unknown Primary	NCT ID:	NCT06111235
Trial Phases:	Phase III	Protocol IDs:	PIVOT-006 (primary) NCI-2024-03570
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	CG Oncology, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT06111235

Summary

This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT
followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the
treatment of participants with IR-NMIBC.

Objectives

Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A)
vs surveillance after TURBT (Arm B).

Participants in Arm A will receive an induction course and then quarterly maintenance
courses of cretostimogene through Month 13, if there is no disease recurrence.

Disease status will be assessed using urine cytology, cystoscopy, and directed
TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and
then every 6 months for an additional year or until disease recurrence. CT Urogram/MRU
every 12 months.

Participants in Arm B who recur with IR-NMIBC after TURBT and surveillance will be
offered treatment with cretostimogene as per the treatment schedule in Arm A.

Treatment Sites in Georgia

Velocity Clinical Research - Savannah Urological Associates
230 East DeRenne Ave
Savannah, GA 31405
(912) 790-4036

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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