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Cretostimogene Grenadenorepvec for Bladder Cancer

Phase 3

Recruiting

Led By Robert Svatek, MD

Research Sponsored by CG Oncology, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 51 months (rfs at 12 months) and 63 months (rfs at 24 months)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effectiveness of two different treatments for participants with a specific type of bladder cancer. One group will receive a treatment called TURBT followed by cretostimogene grenadenore

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified in the provided information. However, as with any medical intervention, there may be risks involved which will be detailed in the consent forms and discussed prior to participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 51 months (rfs at 12 months) and 63 months (rfs at 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~51 months (rfs at 12 months) and 63 months (rfs at 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 51 months (rfs at 12 months) and 63 months (rfs at 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recurrence Free Survival (RFS)

Secondary study objectives

Incidence of Adverse Events

Recurrence Free Survival (RFS) at 12 months and 24 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cretostimogene after TURBTExperimental Treatment2 Interventions

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

Group II: Observation after TURBTActive Control1 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.

0 / 1Eligibility criteria met