Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
NCT ID: NCT04452591
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
190 participants
INTERVENTIONAL
2020-10-27
2029-12-24
Brief Summary
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Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1 papillary bladder cancer.
Under Amendment 6, the target number of patients enrolled in Cohort P was increased to 75. Cohort P is open to enrollment
Cohort C and Cohort P will be analyzed and reported separately. Patients will have had to fail prior BCG therapy which is defined as having persistent or recurrent disease within 12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG therapy for HGUC
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Detailed Description
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An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled 115 patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease
BCG failure is defined as a persistent or recurrent disease within 12 months of completion of adequate BCG therapy.
Cohort P(Japan and the United States Only):
To determine the all-cause High Grade Event Free Survival (HG-EFS) of cretostimogene in up to 75 patients with BCG-unresponsive HG Ta/T1 papillary disease without CIS.
BCG failure is defined as a persistent or recurrent disease within 6 months of completion of adequate BCG therapy.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort C(All Countries):Enrollment Closed
Patients with CIS with or without HG Ta/T1 papillary disease. Cretostimogene will be administered intravesically following a series of bladder washes with 5% DDM and normal saline. Cretostimogene will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the patient has disease recurrence at Week 13, they will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 then the patient will receive 3 weekly treatments. Cohort C(All Countries):Beginning at Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 51 then every 6 months and then a last treatment at Weeks 73, 74, and 75 until the tumor returns or study treatment is completed at Week 97. Cohort C Extension( Japan and the US) At Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 51 then every 6 months starting at Weeks 73, 74, and 75 through Weeks 157, 158, and 159 until the tumor returns or study treatment is completed at Week 159.
Cretostimogene Grenadenorepvec
Engineered Oncolytic Adenovirus
n-dodecyl-B-D-maltoside
Transduction-enhancing agent.
Cohort P(Japan and United States Only) :Open to Enrollment
HG Ta/T1 papillary disease bladder cancer patients.
In Cohort P, cretostimogene will be administered at a dose of 1 × 1012vp IVE following instillation of 5% DDM. Cretostimogene will be administered every week for 6 treatments on Weeks 1, 2, 3, 4, 5, and 6. If the patient has recurrence at Week 13 or any timepoint, the patient will receive a second induction of 6 weekly treatments (Weeks 13, 14, 15, 16, 17, and 18.). If the tumor has not returned they will receive 3 weekly treatments every 12 weeks (approximately 3 months) starting Weeks 13, 14, and 15 through Week 51 (approximately 12 months), and then every 6 months starting at Weeks 73, 74, and 75 (approximately 18 months) through Month 36.
Cretostimogene Grenadenorepvec
Engineered Oncolytic Adenovirus
n-dodecyl-B-D-maltoside
Transduction-enhancing agent.
Interventions
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Cretostimogene Grenadenorepvec
Engineered Oncolytic Adenovirus
n-dodecyl-B-D-maltoside
Transduction-enhancing agent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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CG Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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CG Oncology
Role: STUDY_DIRECTOR
CG Oncology
Locations
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Mayo Clinic Cancer Center
Phoenix, Arizona, United States
Arizona Institute of Urology
Tucson, Arizona, United States
Arkansas Urology
Little Rock, Arkansas, United States
University of California - Irvine
Irvine, California, United States
University of Colorado
Aurora, Colorado, United States
Colorado Clinical Research
Lakewood, Colorado, United States
Urology Associates
Lone Tree, Colorado, United States
MedStar Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Moffit Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Urology of Indiana
Greenwood, Indiana, United States
University of Kansas
Kansas City, Kansas, United States
Wichita Urology
Wichita, Kansas, United States
Southern Urology
Lafayette, Louisiana, United States
Chesapeake Urology
Severna Park, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Rochester
Rochester, Minnesota, United States
Mercy Medical Center
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
University of Toledo
Toledo, Ohio, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Conrad Pearson Clinic
Germantown, Tennessee, United States
Urology Associates- Nashville
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Houston Metro Urology
Houston, Texas, United States
Urology San Antonio, PA
San Antonio, Texas, United States
Spokane Urology
Spokane, Washington, United States
Barwon Health, University Hospital Geelong
Geelong, , Australia
Royal Melbourne Hospital
Melbourne, , Australia
Wollongong Private Hospital
Wollongong, , Australia
National Cancer Center Hospital East
Chiba, , Japan
Nagoya University Hospital
Fujita, , Japan
Hirosaki University Hospital
Hashimoto, , Japan
Chugoku Rosai Hospital
Hiroshima, , Japan
Shinshu University Hospital
Ishizuka, , Japan
University of Tsukuba Hospital
Kandori, , Japan
Nara Medical University Hospital
Kashihara, , Japan
The Jikei University Kashiwa Hospital
Kashiwa, , Japan
St. Marianna University Hospital
Kikuchi, , Japan
National Hospital Organization Kyoto Medical Center
Kyoto, , Japan
Kagawa Rosai Hospital
Marugame, , Japan
Keio University Hospital
Matsumoto, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka City University Hospital
Osaka, , Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka, , Japan
Kitsato University Hospital
Sagamihara, , Japan
Saitama City Hospital
Saitama, , Japan
Sapporo Medical University Hospital
Sapporo, , Japan
Shizuoka General Hospital
Shizuoka, , Japan
Keio University Hospital
Tokyo, , Japan
Toyoma University Hospital
Toyoma, , Japan
Ehime University Hospital
Tōon, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
National Hospital Organization Yokohama Medical Center
Yokohama, , Japan
Pusan National University Hospital
Busan, , South Korea
National Cancer Center
Goyang-si, , South Korea
Pusan National University Yangsan Hospital
Gyeongsang, , South Korea
Chonnam National University Hwasun Hospital
Jeongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea
Seoul, , South Korea
Keelung Chang Gung Memorial Hospital
Keelung, , Taiwan
Keelung Chang Gung Memorial Hospital
Keelung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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CG3002S
Identifier Type: -
Identifier Source: org_study_id
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