Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-25 @ 12:06 PM
Study NCT ID:
NCT04387461
Status:
COMPLETED
Last Update Posted:
2024-09-25
First Post:
2020-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D014571', 'term': 'Urologic 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': 'C582435', 'term': 'pembrolizumab'}, {'id': 'C040358', 'term': 'dodecyl maltoside'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2020-05-05', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response rate in patients', 'timeFrame': '12 months', 'description': 'Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events when CG0070 administered intravesically when combined with pembrolizumab.', 'timeFrame': '12 months', 'description': 'Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0'}, {'measure': 'Median duration of response (DoR)', 'timeFrame': '12 months', 'description': 'Median duration of response in patients with a CR or PR'}, {'measure': 'Median overall survival (OS)', 'timeFrame': '12 months', 'description': 'Median overall survival in months in patients'}, {'measure': 'Median progression free survival', 'timeFrame': '12 months', 'description': 'Median duration of progression free survival of patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-grade Ta papillary disease', 'high-grade T1 papillary disease', 'carcinoma in situ', 'Bacillus-Calmette-Guerin Unresponsive'], 'conditions': ['Non Muscle Invasive Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '38844794', 'type': 'DERIVED', 'citation': 'Li R, Shah PH, Stewart TF, Nam JK, Bivalacqua TJ, Lamm DL, Uchio EM, Geynisman DM, Jacob JM, Meeks JJ, Dickstein R, Pearce SM, Kang SH, Jung SI, Kamat AM, Burke JM, Keegan KA, Steinberg GD. Oncolytic adenoviral therapy plus pembrolizumab in BCG-unresponsive non-muscle-invasive bladder cancer: the phase 2 CORE-001 trial. Nat Med. 2024 Aug;30(8):2216-2223. doi: 10.1038/s41591-024-03025-3. Epub 2024 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.', 'detailedDescription': 'An opened label trial designed to evaluate CG0070 and DDM in combination with Pembrolizumab in patients with NMIBC who have failed prior BCG therapy.\n\nThe target population of 37 subjects with CIS with or without concomitant high-grade Ta or T1 papillary disease will be enrolled.\n\nBCG failure is defined as persistent or recurrent disease within 12 months of completion of adequate BCG therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n* Pathologically confirmed NMIBC with CIS (with or without Ta/T1 disease)\n* Unresponsive to prior BCG therapy (Lerner 2015) defined as persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the sub- epithelial connective tissue) disease within 12 months of completion of adequate BCG therapy. An assessment within 15 months can also qualify when no assessment was performed within 12 months after completion of adequate BCG therapy.\n\n * Adequate BCG is defined as at least 5 treatments with induction BCG followed by at least 2 BCG treatments as reinduction or maintenance\n* Ineligible for radical cystectomy or refusal of radical cystectomy\n* Adequate organ function\n\nKey Exclusion Criteria:\n\n* Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant\n* Prior treatment with adenovirus-based cancer therapy\n* Prior therapy with or intolerant to prior checkpoint inhibitor therapy\n* Clinically significant or active cardiac disease\n* Active autoimmune disease'}, 'identificationModule': {'nctId': 'NCT04387461', 'acronym': 'CORE-001', 'briefTitle': 'Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin', 'organization': {'class': 'INDUSTRY', 'fullName': 'CG Oncology, Inc.'}, 'officialTitle': 'A Phase 2, Single Arm Study of CG0070 Combined With Pembrolizumab in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)', 'orgStudyIdInfo': {'id': 'CG2003C'}, 'secondaryIdInfos': [{'id': 'KEYNOTE-935', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}, {'id': 'MK-3475-935', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'description': 'CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Day 1 to Week 6. If the patient shows persistent high-grade disease at Week 13, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 (e.g., complete response) then the patient will receive 3 weekly treatments.\n\nBeginning at Week 25, patients will receive weekly x 3 treatments every 3 months through Week 49 then every 24 weeks thereafter.\n\nPembrolizumab will be given intravenous (IV) concurrently starting on Day 1 and continue every 6 weeks for up to 2 years.', 'interventionNames': ['Biological: CG0070', 'Biological: Pembrolizumab Injection', 'Other: n-dodecyl-B-D-maltoside']}], 'interventions': [{'name': 'CG0070', 'type': 'BIOLOGICAL', 'description': 'Engineered Oncolytic Adenovirus', 'armGroupLabels': ['Single Arm']}, {'name': 'Pembrolizumab Injection', 'type': 'BIOLOGICAL', 'otherNames': ['KEYTRUDA®'], 'description': 'Immune checkpoint inhibitor, Monoclonal antibody', 'armGroupLabels': ['Single Arm']}, {'name': 'n-dodecyl-B-D-maltoside', 'type': 'OTHER', 'otherNames': ['DDM'], 'description': 'Transduction-enhancing agent.', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California - San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California - Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Medical Institution', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21076', 'city': 'Hanover', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Urology', 'geoPoint': {'lat': 39.19289, 'lon': -76.72414}}, {'zip': '55902-9823', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '17604', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Keystone Urology Specialists', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Spokane Urology', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '58128', 'city': 'Hwasun', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'zip': '02841', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Sinchŏn-dong', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 33.49194, 'lon': 126.90278}}, {'zip': '50612', 'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CG Oncology, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}