Virus therapy shows promise for tough bladder cancer cases

NCT ID NCT04452591

Disease control Sponsor: CG Oncology, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This phase 3 trial is testing a new treatment called cretostimogene grenadenorepvec for people with a type of bladder cancer (non-muscle invasive) that did not improve after standard BCG therapy. The treatment uses a modified virus to target and destroy cancer cells. About 190 participants are enrolled in two groups: one with carcinoma in situ (CIS) and one with papillary tumors. The study measures how many patients achieve a complete response or remain cancer-free for a period of time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: cretostimogene grenadenorepvec (a modified virus that targets cancer cells)
What this could lead to: If successful, this could offer a new treatment option for people with bladder cancer that hasn't responded to standard therapy, potentially avoiding the need for bladder removal.
What could go wrong: This is a single-arm trial without a placebo group, so results may be less definitive. The treatment is still experimental, and long-term safety and effectiveness are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Cohort C Inclusion Criteria In order to be eligible for participation in this trial, the patient must: * Be ≥18 years of age (or legal age of majority in the jurisdiction) on day of signing informed consent. * Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Have pathologically confirmed (WHO grading system employed for tumor grading) (Compérat 2019) BCG unresponsive CIS. Patients with BCG unresponsive CIS are those unlikely to benefit from, and who will not be receiving, further intravesical BCG. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols (e.g., BCG weekly × 6 then weekly × 3 weeks administered at Months 3, 6, 12, 18, 24, and 36). Specifically, the definition of BCG unresponsive CIS will also require the following: * Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease) within 12 months of completion (last dose) of adequate BCG treatment for HGUC (e.g., CIS, HG Ta, HG T1, or a combination of these HGUC pathologies). * Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 12 months of the initial qualifying dose of BCG (e.g., induction and initial maintenance or re-induction cycle must be completed over no more than a 12-month period of time). * Pathological confirmation of BCG unresponsive CIS within 8 weeks of study enrollment. * CIS specimen must be predominantly urothelial (transitional cell) and have less than 50% variant (e.g., sarcomatoid, squamous etc. component) histology. * No maximum limit to the amount of BCG administered but maintenance BCG should be administered on a schedule consistent with the SWOG 8507 regimen (Lamm 2000). * Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment (e.g., prior to Day 1 treatment). * Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment. * Demonstrate adequate organ function * Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial Cohort P Inclusion Criteria * Be ≥18 years of age (or legal age of majority in the jurisdiction) on day of signing informed consent * Have ECOG performance status of 0 to 2. * Have pathologically confirmed (WHO grading system employed for tumor grading) (Compérat 2019) BCG-unresponsive HG Ta/T1 papillary disease without CIS. Patients with BCG-unresponsive HG Ta/T1 papillary disease are those unlikely to benefit from and who will not be receiving further IVE BCG. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive HG Ta/T1 papillary disease without CIS will also require the following: * Pathologically confirmed recurrent HG Ta/T1 papillary disease without CIS within 6 months of completion (last dose) of adequate BCG treatment for HGUC (e.g., CIS, HG Ta, HG T1, or a combination of these HGUC pathologies). * Patients with HG Ta: Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 12 months of the initial qualifying dose of BCG (e.g., induction and initial maintenance or re-induction cycle must be completed over no more than a 12-month period of time). * Patients with HG T1: Patients may be eligible after the initial induction alone (5 of 6 doses of an induction course) as the qualifying BCG treatment. * Completion (last dose) of qualifying BCG treatment within 12 months of study enrollment. * Pathological confirmation of BCG-unresponsive HG Ta/T1 papillary disease without CIS within 14 days of study enrollment. * All pathology specimens must be predominantly urothelial (transitional cell) and have less than 50% variant (e.g., sarcomatoid, squamous etc. component) histology. * No maximum limit to the amount of BCG administered; however, there should be no more than 12 months between cycles of BCG * Have all Ta and/or T1 disease resected, prior to study treatment (e.g., prior to Day 1 treatment). * Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy based on Investigator assessment. * Demonstrate adequate organ function, * Patients must be willing to comply with study-mandated cystoscopies, urine cytology, imaging, biopsies, and other procedures for the duration of the trial Cohort C and Cohort P Key Exclusion Criteria: * Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer. * Any HGUC as T1, HG Ta, or CIS in the upper genitourinary tract or prostatic urethra (including CIS of the urethra) within 24 months prior to enrollment OR any history of T2 or higher stage urothelial carcinoma in the upper genitourinary tract (kidneys, renal collecting systems, ureters). * Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of Day 1. * Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies. * Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure. * Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of cretostimogene. * IVE therapy within 8 weeks prior to beginning study treatment with the exception of cytotoxic agents (e.g., Mitomycin C, gemcitabine, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure which is permitted 14 or more days prior to beginning study treatment

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ bladder papillary urothelial carcinoma in situ carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High-grade ta/ T1 papillary disease bladder cancer Non-muscle invasive bladder cancer

Contacts and locations

Locations

American Insititute of Research

Los Angeles, California, 90017, United States
Arizona Institute of Urology

Tucson, Arizona, 85704, United States
Arkansas Urology

Little Rock, Arkansas, 72211, United States
BCG Oncology

Phoenix, Arizona, 85032, United States
Barwon Health, University Hospital Geelong, Andrew love cancer center

Geelong, Australia
Baylor Scott & White Medical Center-Temple

Temple, Texas, 76508, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
CHUM Center for Research

Montreal, Quebec, H2X0A9, Canada
Carolina Urologic Research Center LLC

Myrtle Beach, South Carolina, 29572, United States
Chesapeake Urology

Hanover, Maryland, 21076, United States
Chesapeake Urology

Severna Park, Maryland, 21076, United States
China Medical University Hospital

Taichung, 40447, Taiwan
Chonnam National University Hwasun Hospital

Jeongnam, 58128, South Korea
Chugoku Rosai Hospital

Hiroshima, Japan
Colorado Clinical Research

Lakewood, Colorado, 80228, United States
Conrad Pearson Clinic

Germantown, Tennessee, 38138, United States
Duke University

Durham, North Carolina, 27710, United States
Ehime University Hospital

Tōon, Ehime, 791-0295, Japan
Emory University

Atlanta, Georgia, 30322, United States
Genesis Research

Sherman Oaks, California, 91411, United States
Genesis Research LLC

Torrance, California, 90505, United States
Hirosaki University Hospital

Hashimoto, Japan
Houston Metro Urology

Houston, Texas, 77027, United States
Kagawa Rosai Hospital

Marugame, Kagawa-ken, 763-8502, Japan
Keelung Chang Gung Memorial Hospital

Keelung, 20401, Taiwan
Keio University Hospital

Matsumoto, Tokyo, 160-8582, Japan
Keio University Hospital

Tokyo, Tokyo, 160-8582, Japan
Keystone Urology Specialists

Lancaster, Pennsylvania, 17601, United States
Kitsato University Hospital

Sagamihara, Japan
Korea University Anam Hospital

Seoul, 02841, South Korea
MUHC Glen-Ceders Cancer Centre, Oncology Pharmacy

Montreal, Quebec, H4A 3JI, Canada
Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States
Mayo Clinic Cancer Center

Phoenix, Arizona, 85054, United States
Mayo Rochester

Rochester, Minnesota, 55905, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Mercy Medical Center

St Louis, Missouri, 63109, United States
Moffit Cancer Center

Tampa, Florida, 33612, United States
Montifiore Medical Center

The Bronx, New York, 10461, United States
Nagoya University Hospital

Fujita, Japan
Nara Medical University Hospital

Kashihara, Nara, 634-8522, Japan
National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea
National Cancer Center Hospital East

Chiba, Japan
National Hospital Organization Kyoto Medical Center

Kyoto, Kyoto, 6128555, Japan
National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, 245-8575, Japan
National Taiwan University Hospital

Taipei, Taiwan
New Jersey Premier Urology

Edison, New Jersey, 08837, United States
Okayama University Hospital

Okayama, Okayama-ken, 700-8558, Japan
Osaka City University Hospital

Osaka, Osaka, 545-8586, Japan
Osaka International Cancer Institute

Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital

Osaka, Osaka, 569-8686, Japan
Our Lady of Lourdes

Binghamton, New York, 13905, United States
Prisma Health - Regional Urology

Greenville, South Carolina, 29605, United States
Pusan National University Hospital

Busan, 49241, South Korea
Pusan National University Yangsan Hospital

Gyeongsang, 50612, South Korea
Royal Melbourne Hospital

Melbourne, Australia
Saitama City Hospital

Saitama, Saitama, 3368522, Japan
Sapporo Medical University Hospital

Sapporo, Hokkaido, 060-8543, Japan
Seoul National University Hospital

Seoul, 03080, South Korea
Shinshu University Hospital

Ishizuka, Japan
Shizuoka General Hospital

Shizuoka, Shizuoka, 420-8527, Japan
Southern Urology

Lafayette, Louisiana, 70508, United States
Southside Cancer Care Center

Miranda, New South Wales, 2228, Australia
Specialty Clinical Research of St. Louis

St Louis, Missouri, 63141, United States
Spokane Urology

Spokane, Washington, 99202, United States
St. Marianna University Hospital

Kawasaki, Kanagawa, 216-8511, Japan
Stony Brook University

Stony Brook, New York, 11794, United States
Taipei Veterans General Hospital

Taipei, 11217, Taiwan
The Catholic University of Korea

Seoul, 06591, South Korea
The Jikei University Kashiwa Hospital

Kashiwa-shi, Chiba, 227-8567, Japan
The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States
Toyama University Hospital

Toyama, Toyama, 930-0194, Japan
University of California - Irvine

Irvine, California, 92868, United States
University of Colorado

Aurora, Colorado, 80045, United States
University of Pennsylvania, Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States
University of Toledo

Toledo, Ohio, 43614, United States
University of Tsukuba Hospital

Kandori, Ibaraki, 305-8576, Japan
Urology Associates, Research Department

Lone Tree, Colorado, 80124, United States
Urology Associates- Nashville

Nashville, Tennessee, 37209, United States
Urology Centers Alabama

Homewood, Alabama, 35209, United States
Urology Indiana LLC

Greenwood, Indiana, 46143, United States
Urology San Antonio, PA

San Antonio, Texas, 78229, United States
Vanderbilt University Medical Center, Dept of Urology

Nashville, Tennessee, 37232, United States
Wakayama Medical University Hospital

Wakayama, Wakayama, 6418510, Japan
Wake Forest

Winston-Salem, North Carolina, 27157, United States
Washington University

St Louis, Missouri, 63130, United States
Wichita Urology

Wichita, Kansas, 67226, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.