Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-29 @ 4:58 AM
Study NCT ID:
NCT04568304
Status:
UNKNOWN
Last Update Posted:
2020-09-29
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656314', 'term': 'toripalimab'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 364}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-23', 'studyFirstSubmitDate': '2020-09-17', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Investigator-assessed PFS', 'timeFrame': 'Approximately 4 years', 'description': 'Investigator-assessed progression-free survival to explore the efficacy of crossover to Toripalimab Injection in control group'}, {'measure': 'Investigator-assessed ORR', 'timeFrame': 'Approximately 4 years', 'description': 'Investigator-assessed overall response rate to explore the efficacy of crossover to Toripalimab Injection in control group'}, {'measure': 'Investigator-assessed DCR', 'timeFrame': 'Approximately 4 years', 'description': 'Investigator-assessed disease control rate to explore the efficacy of crossover to Toripalimab Injection in control group'}, {'measure': 'Investigator-assessed DoR', 'timeFrame': 'Approximately 4 years', 'description': 'Investigator-assessed duration of response to explore the efficacy of crossover to Toripalimab Injection in control group'}], 'primaryOutcomes': [{'measure': 'Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria', 'timeFrame': 'Approximately 3 years', 'description': 'To evaluate the investigator-assessed progression-free survival following Toripalimab Injection in combination with chemotherapy compared to placebo in combination with chemotherapy in subjects with PD-L1-positive unresectable locally advanced or metastatic urothelial carcinoma who have received no previous systemic therapy'}], 'secondaryOutcomes': [{'measure': 'IRC-PFS', 'timeFrame': 'Approximately 3 years', 'description': 'Independent central radiological review committee-assessed progression-free survival as per RECIST1.1 criteria'}, {'measure': 'INV-ORR, IRC-ORR', 'timeFrame': 'Approximately 3 years', 'description': 'Investigator- and IRC-assessed overall response rate'}, {'measure': 'INV-DCR, IRC-DCR', 'timeFrame': 'Approximately 3 years', 'description': 'Investigator- and IRC-assessed disease control rate'}, {'measure': 'INV-DoR, IRC- DoR', 'timeFrame': 'Approximately 3 years', 'description': 'Investigator- and IRC-assessed duration of response'}, {'measure': 'OS', 'timeFrame': 'Approximately 5 years', 'description': 'Overall survival'}, {'measure': 'OS rate at 1 year', 'timeFrame': 'Approximately 3 years', 'description': 'Overall survival rate at 1 year'}, {'measure': 'OS rate at 2 years', 'timeFrame': 'Approximately 4 years', 'description': 'Overall survival rate at 2 years'}, {'measure': 'INV-PFS rate and IRC-PFS rate at 6 months', 'timeFrame': 'Approximately 2.5 years', 'description': 'Investigator- and IRC-assessed progression-free survival rate at 6 months'}, {'measure': 'INV-PFS rate and IRC-PFS rate at 1 year', 'timeFrame': 'Approximately 3 years', 'description': 'Investigator- and IRC-assessed progression-free survival rate at 1 year'}, {'measure': 'Incidence of AEs/SAEs', 'timeFrame': 'Approximately 4 years', 'description': 'Study drug related adverse events, serious adverse events graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced or Metastatic Urothelial Carcinoma']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy and safety of Toripalimab Injection in combination with chemotherapy compared to placebo in combination with chemotherapy in subjects with PD-L1-positive unresectable locally advanced or metastatic urothelial carcinoma who have received no previous systemic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Have full knowledge on this study and are willing to sign informed consent form (ICF);\n2. Age 18-75 years at time of signing ICF, male or female;\n3. The investigator judged that the subject is eligible for platinum-based chemotherapy;\n4. Presence of histopathologically confirmed unresectable locally advanced (T4, any N; or any T, N2-3) or metastatic urothelial carcinoma;\n5. No prior systemic anti-tumor therapy;\n6. Subjects who are able to provide tumor tissue slides (≥ 5 slides) for PD-L1 test and the corresponding pathology report and whose PD-L1 test must be positive before randomization;\n7. With at least one measurable lesion as per RECIST 1.1 criteria;\n8. ECOG performance status score of 0-1;\n9. Adequate function of vital organs.\n\nExclusion criteria\n\n1. Have received anti-tumor treatments, including chemotherapy, radiotherapy or investigational product within 28 days before randomization;\n2. Have received traditional Chinese medicines with anti-tumor activity or immunomodulators (eg. Interferon and Interleukin) within 14 days before randomization;\n3. Previous use of anti-PD-1/PD-L1 agent or a drug acting on another co-inhibitory T cell receptor;\n4. Subjects who are currently participating in or have participated in a study with investigational product within 4 weeks before administration;\n5. Having received systemic corticosteroid therapy (dose equivalent to prednisone \\> 10 mg/day) within 14 days before randomization;\n6. Subjects with active central nervous system (CNS) metastasis;\n7. Grade 2 or higher peripheral neuropathy or hearing loss.'}, 'identificationModule': {'nctId': 'NCT04568304', 'briefTitle': 'A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Junshi Bioscience Co., Ltd.'}, 'officialTitle': 'A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) in Combination With Standard Chemotherapy Versus Placebo in Combination With Standard Chemotherapy as the 1st-line Therapy for Treatment-naive Subjects With PD-L1-positive Locally Advanced or Metastatic Urothelial Carcinoma', 'orgStudyIdInfo': {'id': 'JS001-038-III-UBC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toripalimab Injection + chemotherapy group', 'interventionNames': ['Biological: Toripalimab Injection', 'Drug: Gemcitabine Hydrochloride for Injection', 'Drug: Cisplatin for Injection / Carboplatin Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + chemotherapy group', 'interventionNames': ['Drug: Gemcitabine Hydrochloride for Injection', 'Drug: Cisplatin for Injection / Carboplatin Injection', 'Drug: Placebo']}], 'interventions': [{'name': 'Toripalimab Injection', 'type': 'BIOLOGICAL', 'description': 'Toripalimab Injection 240 mg iv infusion on Day 1 of each 3-week cycle. The cumulative duration of Toripalimab Injection is up to 2 years.', 'armGroupLabels': ['Toripalimab Injection + chemotherapy group']}, {'name': 'Gemcitabine Hydrochloride for Injection', 'type': 'DRUG', 'description': 'Gemcitabine 1000mg/㎡ iv infusion, on Day 1 and Day 8 of each cycle, each treatment cycle is 3 weeks.\n\nThe chemotherapy regimen will be administered for 6 cycles.', 'armGroupLabels': ['Placebo + chemotherapy group', 'Toripalimab Injection + chemotherapy group']}, {'name': 'Cisplatin for Injection / Carboplatin Injection', 'type': 'DRUG', 'description': 'Cisplatin 70mg/㎡ iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.\n\nCarboplatin AUC 4.5 iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.\n\nThe chemotherapy regimen will be administered for 6 cycles.', 'armGroupLabels': ['Placebo + chemotherapy group', 'Toripalimab Injection + chemotherapy group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo iv infusion on Day 1 of each 3-week cycle. The cumulative duration of placebo is up to 2 years.', 'armGroupLabels': ['Placebo + chemotherapy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Jun Guo, Prof', 'role': 'CONTACT'}], 'facility': 'Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Zhisong He, Prof', 'role': 'CONTACT'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Yiran Huang, Prof', 'role': 'CONTACT'}], 'facility': 'Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jun Guo, Prof', 'role': 'CONTACT', 'email': 'guoj307@126.com', 'phone': '86-010-88196348'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Junshi Bioscience Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}