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Cretostimogene after TURBT 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recurrence Free Survival (RFS)

Secondary outcome measures

Incidence of Adverse Events

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

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

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Who is running the clinical trial?

CG Oncology, Inc.Lead Sponsor

6 Previous Clinical Trials

254 Total Patients Enrolled

Robert Svatek, MDPrincipal InvestigatorUniversity of Texas Health Science Center, San Antonio

2 Previous Clinical Trials

39 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals under observation in this clinical investigation?

"Indeed, as stated on clinicaltrials.gov, this trial is actively seeking participants. The initial posting of the trial took place on December 14th, 2023, and the most recent update occurred on December 19th, 2023. In order to complete the study successfully, a total of 426 patients will be enrolled at one designated site."

Answered by AI

Is the enrollment for this trial currently open?

"Indeed, the details on clinicaltrials.gov confirm that this trial is actively seeking potential candidates. The study was initially posted on December 14th, 2023 and most recently updated on December 19th, 2023. Recruitment aims to enroll a total of 426 participants at a single site or location."

Answered by AI

Has Cretostimogene been granted approval by the FDA for use following transurethral resection of bladder tumor (TURBT)?

"Based on the Phase 3 trial status, Cretostimogene's safety after TURBT is projected to be a level 3. This assessment considers both prior evidence of effectiveness and multiple rounds of safety data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06111235.

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