Cretostimogene Grenadenorepvec for Bladder Cancer

Recruiting at 87 trial locations

Overseen By Andy Darilek, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: CG Oncology, Inc.

Disqualifiers: High-risk NMIBC, Low-risk NMIBC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 13 months

364 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Robert Svatek, MD

Principal Investigator

University of Texas Health Science Center San Antonio

Eligibility Criteria

This trial is for people with a type of bladder cancer called Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC). Participants should have had certain low-grade tumors treated within the last 12 months or high-grade tumors smaller than 3 cm, and all visible disease must be removed recently. They need to have good organ function.

Inclusion Criteria

My organs are functioning well.

My bladder cancer has come back within a year or is larger/multiple low-grade tumors.

My low-grade T1 tumor was completely removed recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

13 months

Quarterly visits for maintenance courses

Observation

Participants in Arm B are observed after TURBT for disease recurrence.

Up to 24 months

Every 3 months for the first 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment or observation.

3 years

Every 6 months for an additional year or until disease recurrence

Extension

Participants in Arm B who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene.

As per treatment schedule in Arm A

Treatment Details

Interventions

• Cretostimogene Grenadenorepvec

Trial Overview The study compares two approaches after tumor removal surgery (TURBT): one group receives an experimental therapy called Cretostimogene Grenadenorepvec, while the other group is just observed without additional treatment. The goal is to see which method is better at preventing cancer recurrence.

Participant Groups

Group I: Cretostimogene after TURBT Experimental Treatment 2 Interventions

Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.

Group II: Observation after TURBT Active Control 1 Intervention

Following screening confirmation of IR-NMIBC and complete resection of tumor, participants will enter observation. Participants who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A. This arm will be called the Extension Arm.

Who Is Running the Clinical Trial?

CG Oncology, Inc.

Lead Sponsor

Trials

9

Recruited

900+