CG Oncology Initiates PIVOT-006 Phase 3 Trial for Cretostimogene Targeting Intermediate-risk NMIBC
Overview
- Company: CG Oncology, Inc.
- Indication: Intermediate-risk Non-Muscle Invasive Bladder Cancer (NMIBC)
- Drug: Cretostimogene
- Trial Phase: Phase 3
- NCT ID: NCT06111235
Trial Details
On February 27, 2024, CG Oncology announced the commencement of their Phase 3 PIVOT-006 clinical trial. This pivotal study will evaluate the efficacy and safety of the drug cretostimogene in patients with intermediate-risk NMIBC following transurethral resection of bladder tumor (TURBT).
Objectives
The trial primarily aims to improve recurrence-free survival (RFS) in NMIBC patients. Secondary endpoints include RFS at 12 and 24 months, and progression-free survival (PFS).
Treatment Protocol
The study is designed to have two arms with up to 426 participants:
- Cretostimogene Arm: Patients will receive an induction of cretostimogene at 1x1012 viral particles/ml for six weeks post-TURBT, followed by a maintenance schedule if no recurrence is observed at the three-month checkpoint.
- Control Arm: Patients will undergo the standard TURBT treatment only.
Broader Context
NMIBC presents a significant health challenge, making up about 75% of the over 83,000 bladder cancer cases expected in 2024. CG Oncology is dedicated to advancing their immunotherapeutic initiatives to potentially improve outcomes for patients with this form of cancer.
Company Statement
CG Oncology expresses a cautiously optimistic outlook on the potential of cretostimogene. The company underscores the critical need for innovative treatments to break the cycle of frequent disease recurrence in intermediate-risk NMIBC.