Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT06111235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2023-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C040358', 'term': 'dodecyl maltoside'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 367}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-10-30', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence Free Survival (RFS)', 'timeFrame': '51 months', 'description': 'Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT'}], 'secondaryOutcomes': [{'measure': 'Recurrence Free Survival (RFS) at 12 months and 24 months', 'timeFrame': '51 months (RFS at 12 months) and 63 months (RFS at 24 months)', 'description': 'Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT at 12 months and 24 months'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': '52 months', 'description': 'Safety of cretostimogene following TURBT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urology', 'Bladder Cancer', 'Non Muscle Invasive Bladder Cancer', 'Intermediate Risk Non Muscle Invasive Bladder Cancer', 'Cretostimogene Grenadenorepvec'], 'conditions': ['Non Muscle Invasive Bladder Cancer', 'Urologic Cancer', 'Bladder Cancer', 'Urothelial Carcinoma']}, 'referencesModule': {'references': [{'pmid': '27317986', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.nccn.org/guidelines/recently-published-guidelines', 'label': 'NCCN Guidelines Bladder Cancer 3.2023'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs surveillance after TURBT (Arm B).\n\nParticipants in Arm A will receive an induction course and then quarterly maintenance courses of cretostimogene through Month 13, if there is no disease recurrence.\n\nDisease 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:\n\n 1. Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor\n 2. Solitary LG Ta \\>3 cm tumor\n 3. Multifocal LG Ta tumors\n 4. Primary and solitary HG Ta ≤3 cm tumor\n 5. LG T1 tumor\n* All visible disease removed by TURBT within 90 days of study randomization\n* Acceptable baseline organ function\n\nExclusion Criteria:\n\n* High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta\\>3cm tumor(s), CIS)\n* Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor)\n* Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization\n* Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer\n* Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Adstiladrin)'}, 'identificationModule': {'nctId': 'NCT06111235', 'briefTitle': 'A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT', 'organization': {'class': 'INDUSTRY', 'fullName': 'CG Oncology, Inc.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'PIVOT-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cretostimogene after TURBT', 'description': 'Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.', 'interventionNames': ['Drug: Cretostimogene Grenadenorepvec', 'Other: n-dodecyl-B-D-maltoside']}, {'type': 'NO_INTERVENTION', 'label': 'Observation after TURBT', 'description': 'Following screening confirmation of IR-NMIBC and complete resection of tumor, participants will enter surveillance.\n\nParticipants 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.'}], 'interventions': [{'name': 'Cretostimogene Grenadenorepvec', 'type': 'DRUG', 'otherNames': ['CG0070'], 'description': 'Engineered Oncolytic Adenovirus', 'armGroupLabels': ['Cretostimogene after TURBT']}, {'name': 'n-dodecyl-B-D-maltoside', 'type': 'OTHER', 'otherNames': ['DDM'], 'description': 'Transduction-enhancing agent', 'armGroupLabels': ['Cretostimogene after TURBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Urology Centers of Alabama PC', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Institute of Urology PLLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Urology PA', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '93301-2284', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Michael G. Oefelein MD Clinical Trials', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Keck Department of Urology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Tower Urology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Sun Kim Urology', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine Medical Center (UCIMC)', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Cancer Center', 'geoPoint': {'lat': 38.58157, 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