Trial intelligence / Profile preview

Cretostimogene Grenadenorepvec in BCG-Unresponsive NMIBC

NCT04452591Phase 3

Key facts

Status: Active, not recruiting
Start: Oct 2020
Primary completion: Jun 2030
Countries: 6
Sponsor: CG Oncology, Inc.
Modality: Gene Editing, Gene Silencing, Oncolytic Viruses

Drugs: cretostimogene grenadenorepvec
Conditions: non-muscle-invasive bladder cancer (NMIBC)

Overview

Phase 3, open-label trial of cretostimogene grenadenorepvec in non-muscle-invasive bladder cancer (NMIBC) (2 cohorts), sponsored by CG Oncology, Inc. Primary endpoints: Complete Response at 36 months and High Grade Event Free Survival at 36 months. Started Oct 2020; status: active, not recruiting.

Design

2 arms

Study design: Non-randomizedOpen-label

Cohort C
Patients with CIS with or without HG Ta/T1 papillary disease
Cohort P
HG Ta/T1 papillary disease bladder cancer patients without CIS

Who it enrols

Patients must have BCG-unresponsive CIS (Cohort C) or BCG-unresponsive HG Ta/T1 papillary disease without CIS (Cohort P) and be ineligible for or refuse radical cystectomy.

Endpoints

Primary

Complete Response36 months
High Grade Event Free Survival36 months

Secondary

Duration of Response36 months
High-grade Recurrence-Free Survivalup to 60 months
Progression-Free Survivalup to 60 months
Complete Response rate at 12 months12 months
Cystectomy-Free Survivalup to 60 months
Safety of Cretostimogene36 months
Overall Survivalup to 60 months
Recurrence-Free Survivalup to 60 months

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