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Treatment for Intermediate Risk Non Muscle Invasive Bladder Cancer after Surgery

A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec Versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)

Phase 3 Interventional CG Oncology, Inc. · NCT06111235

This study is testing a new treatment to see if it can help prevent bladder cancer from coming back in people who have had surgery for it.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment364 (estimated)
Ages18 Years and up
SexAll
SponsorCG Oncology, Inc. Industry-sponsored
Locations94 sites (Homewood, Alabama and 93 other locations)
Trial IDNCT06111235 on ClinicalTrials.gov

What this trial studies

This Phase 3, open-label, randomized trial evaluates the effectiveness of cretostimogene grenadenorepvec in preventing recurrence of intermediate risk non muscle invasive bladder cancer (IR-NMIBC) following transurethral resection of bladder tumor (TURBT). Participants will be randomly assigned to receive either the treatment or standard surveillance after TURBT. Those receiving the treatment will undergo an induction course followed by quarterly maintenance doses for up to 13 months, while disease status will be monitored through regular assessments. If participants in the surveillance group experience recurrence, they will be offered the treatment as well.

Who should consider this trial

Good fit: Ideal candidates are individuals with pathologically confirmed intermediate risk non muscle invasive bladder cancer who have had all visible disease removed by TURBT within the last 90 days.

Not a fit: Patients with high-risk non muscle invasive bladder cancer, muscle-invasive bladder cancer, or those who have previously received certain adenovirus-based therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of cancer recurrence in patients with intermediate risk non muscle invasive bladder cancer.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:

  1. Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor
  2. Solitary LG Ta \>3 cm tumor
  3. Multifocal LG Ta tumors
  4. Primary and solitary HG Ta ≤3 cm tumor
  5. LG T1 tumor
* All visible disease removed by TURBT within 90 days of study randomization
* Acceptable baseline organ function

Exclusion Criteria:

* High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta\>3cm tumor(s), CIS)
* Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor)
* Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization
* Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer
* Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Adstiladrin)

Where this trial is running

Homewood, Alabama and 93 other locations

+44 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non Muscle Invasive Bladder CancerUrologic CancerBladder CancerUrothelial CarcinomaUrologyIntermediate Risk Non Muscle Invasive Bladder CancerCretostimogene Grenadenorepvec
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.