AzTrials
AzTrials

Non Muscle Invasive Bladder CancerPhase 3NCT06111235

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

A Phase 3 study testing Cretostimogene Grenadenorepvec and n-dodecyl-B-D-maltoside in people with Non Muscle Invasive Bladder Cancer and Urologic Cancer, run by CG Oncology, Inc. at 95 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Cretostimogene Grenadenorepvec and n-dodecyl-B-D-maltoside
Could I receive a placebo?
No, everyone receives an active treatment
How many people
367 participants
Where
95 sitesin 2 countries
Study dates
14 Dec 2023to Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:
  • 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
  • Primary and solitary HG Ta ≤3 cm tumor
  • LG T1 tumor
  • All visible disease removed by TURBT within 90 days of study randomization
  • Acceptable baseline organ function

Who cannot join

  • 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)

Trial locations and contacts

95 sites in 2 countries.

95 sites in 2 countries

United States90 sites

  • Amarillo Urology Research, LLC

    Amarillo, Texas, 79106

  • Urology Associates of North Texas

    Arlington, Texas, 76017

  • Emory Winship Cancer Center

    Atlanta, Georgia, 30322

  • Colorado Clinical Research

    Aurora, Colorado, 80012

  • Urology Austin, PLLC

    Austin, Texas, 78745

  • Michael G. Oefelein MD Clinical Trials

    Bakersfield, California, 93301-2284

  • Midlantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Chesapeake Urology Associates, LLC

    Baltimore, Maryland, 21204

  • Johns Hopkins Hospital Green Spring Station

    Baltimore, Maryland, 21287

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

  • Cancer Center at Beth Israel Deaconess Medical Center - Research

    Boston, Massachusetts, 02215

  • Urology of Indiana, LLC

    Carmel, Indiana, 46032

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Urology Group

    Cincinnati, Ohio, 45212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Advanced Urology Institute

    Daytona Beach, Florida, 32114

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke Cancer Center

    Durham, North Carolina, 27710

  • The Conrad Pearson Clinic

    Germantown, Tennessee, 38138

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • UroPartners LLC

    Glenview, Illinois, 60026

  • Urology of Indiana

    Greenwood, Indiana, 46143

  • Hartford HealthCare Medical Group

    Hartford, Connecticut, 06106

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Urology Centers of Alabama PC

    Homewood, Alabama, 35209

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030

  • Houston Metro Urology

    Houston, Texas, 77074

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224

  • Southern Urology

    Lafayette, Louisiana, 70508

  • Lakeland Regional Health

    Lakeland, Florida, 33805

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604

  • Advanced Urology Institute, LLC

    Largo, Florida, 33771

  • Duly Health and Care

    Lisle, Illinois, 601152

  • Arkansas Urology PA

    Little Rock, Arkansas, 72211

  • Urology Associates, PC

    Lone Tree, Colorado, 80124

  • USC/Keck Department of Urology

    Los Angeles, California, 90033

  • Tower Urology

    Los Angeles, California, 90048

  • First Urology, PSC

    Louisville, Kentucky, 47130

  • University of Wisconsin Medical Foundation

    Madison, Wisconsin, 53705

  • University of Miami

    Miami, Florida, 33136

  • Garden State Urology, LLC- Morristown Medical Center

    Morristown, New Jersey, 07962

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute of New Jersey - Cancer Center

    New Brunswick, New Jersey, 08901

  • Integrated Medical Professionals PLLC

    New York, New York, 10016

  • NYU Langone Health

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Lowcountry Urology Clinics

    North Charleston, South Carolina, 29406

  • Sun Kim Urology

    Orange, California, 92868

  • University of California Irvine Medical Center (UCIMC)

    Orange, California, 92868

  • University of Pennsylvania - Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • The Miriam Hospital

    Providence, Rhode Island, 02905

  • Urology Nevada

    Reno, Nevada, 89511

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Comprehensive Urology

    Roseville, Michigan, 48066

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • University of Utah- Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Urology San Antonio PA

    San Antonio, Texas, 78229

  • UT Health San Antonio

    San Antonio, Texas, 78229

  • Velocity Clinical Research- Savanah Urological Associates

    Savannah, Georgia, 31405

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • The Urology Group

    Southaven, Mississippi, 38671

  • Spokane Urology- Southside

    Spokane, Washington, 99202

  • Oregon Urology Insititute

    Springfield, Oregon, 97477

  • Specialty Clinical Research of St. Louis

    St Louis, Missouri, 63141

  • Stanford University School of Medicine

    Stanford, California, 94305

  • Stony Brook University

    Stony Brook, New York, 11794

  • Associated Medical Professionals of NY

    Syracuse, New York, 13202

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • University of Toledo

    Toledo, Ohio, 43614

  • Michigan Institute of Urology, PC

    Troy, Michigan, 48084

  • Arizona Institute of Urology PLLC

    Tucson, Arizona, 85745

  • Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology)

    Virginia Beach, Virginia, 23462

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Urology Center of Iowa Research

    West Des Moines, Iowa, 50266

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Wichita Urology Group

    Wichita, Kansas, 67226

Other trials in United States

Canada5 sites

  • Nova Scotia Health Centre of Applied Urology Research

    Halifax, Nova Scotia, B3H 2Y9

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • McGill University Health Center - Montreal General Hospital

    Montreal, Quebec, H4A 3J1

  • University Health Network (UHN) - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5

  • Vancouver Prostate Centre

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Official title: 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)

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

Read the detailed description

Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs surveillance after TURBT (Arm B).

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

Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence. CT Urogram/MRU every 12 months.

Participants in Arm B who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with cretostimogene as per the treatment schedule in Arm A.

Being tested
Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
Keywords
Urology, Bladder Cancer, Non Muscle Invasive Bladder Cancer, Intermediate Risk Non Muscle Invasive Bladder Cancer, Cretostimogene Grenadenorepvec
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms, Urologic Neoplasms, Urinary Bladder Neoplasms, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cretostimogene GrenadenorepvecDrug

    Also called CG0070

    Engineered Oncolytic Adenovirus

  • n-dodecyl-B-D-maltosideOther

    Also called DDM

    Transduction-enhancing agent

Study groups in NCT06111235
Study groupRoleWhat they receive
Cretostimogene after TURBTExperimentalFollowing screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.
Receives: Drug: Cretostimogene Grenadenorepvec; Other: n-dodecyl-B-D-maltoside
Observation after TURBTNo interventionFollowing screening confirmation of IR-NMIBC and complete resection of tumor, participants will enter surveillance. Participants who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with cretostimogene as per the treatment schedule in Arm A. This arm will be called the Extension Arm.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence Free Survival (RFS)

    Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT

    Measured: 29 months

Secondary outcomes (2)

  1. Recurrence Free Survival (RFS) at 6 months, 12 months and 24 months

    Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT at 12 months and 24 months

    Measured: 27 months (RFS at 6 months), 33 months (RFS at 12 months) and 45 months (RFS at 24 months)

  2. Incidence of Adverse Events

    Safety of cretostimogene following TURBT

    Measured: 34 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2023
  2. Study start14 Dec 2023
  3. Primary completionNov 2026 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by adjuvant cretostimogene versus TURBT alone for the treatment of participants with IR-NMIBC
Masking
None (open label)
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06111235
Sponsor's protocol ID
PIVOT-006
Status last verified
Jun 2026
First submitted
25 Oct 2023
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, Pruthi R, Quale DZ, Ritch CR, Seigne JD, Skinner EC, Smith ND, McKiernan JM. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016 Oct;196(4):1021-9. doi: 10.1016/j.juro.2016.06.049. Epub 2016 Jun 16.

    PubMed 27317986

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cretostimogene Grenadenorepvec and n-dodecyl-B-D-maltoside in people with Non Muscle Invasive Bladder Cancer and Urologic Cancer, run by CG Oncology, Inc. at 95 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence Free Survival (RFS) (time frame: 29 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06111235, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in