Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT05699135
Status:
TERMINATED
Last Update Posted:
2024-04-24
First Post:
2022-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn About the Effect of Avelumab First-Line Maintenance in Canadian People With Advanced Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '12 months', 'description': 'OS from the date of avelumab initiation to the date of death from any cause'}, {'measure': 'Progression-free survival', 'timeFrame': '12 months', 'description': 'Progression-free survival from the date of avelumab first-line maintenance initiation to the date of progression or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Adverse events explicitly attributed to avelumab', 'timeFrame': '12 months', 'description': 'Description of AEs explicitly attributed to avelumab among patients with LA/mUC treated with AVE 1LM'}, {'measure': 'Response rate', 'timeFrame': '12 months', 'description': 'Response rate from date of AVE 1LM initiation, and separately, from the date of chemotherapy initiation, and DOR from date of best overall response in each line of therapy'}, {'measure': 'Description of patient characteristics', 'timeFrame': '12 months'}, {'measure': 'Overall survival from the date of chemotherapy initiation to the date of death from any cause', 'timeFrame': '12 months', 'description': 'OS from the date of chemotherapy initiation (prior to AVE 1LM) to the date of death from any cause'}, {'measure': 'Progression-free survival from the date of chemotherapy initiation to the date of progression or death from any cause', 'timeFrame': '12 months', 'description': 'PFS from the date of chemotherapy initiation (prior to AVE 1LM) to the date of progression or death from any cause'}, {'measure': 'First-Line therapy description', 'timeFrame': '12 months', 'description': 'First-line therapy type, dose, number of cycles, switching and discontinuations'}, {'measure': 'Time to post-diagnostic imaging', 'timeFrame': '12 months', 'description': 'Time to post-diagnostic imaging'}, {'measure': 'Time to treatment discontinuation', 'timeFrame': '12 months', 'description': 'Time to treatment discontinuation'}, {'measure': 'Time to initiation of AVE 1LM following last dose of chemotherapy', 'timeFrame': '12 months', 'description': 'Time to initiation of AVE 1LM following last dose of chemotherapy'}, {'measure': 'Treatment duration of AVE 1LM', 'timeFrame': '12 months', 'description': 'Treatment duration of AVE 1LM'}, {'measure': 'Time to next treatment', 'timeFrame': '12 months', 'description': 'Time to next treatment'}, {'measure': 'Reasons for treatment discontinuation', 'timeFrame': '12 months', 'description': 'Reasons for treatment discontinuation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bladder Cancer', 'Bladder Neoplasms', 'Bladder Tumors', 'Cancer of Bladder', 'Cancer of the Bladder', 'Malignant Tumor of Urinary Bladder', 'Neoplasms, Bladder', 'Urinary Bladder Cancer', 'Metastatic bladder cancer', 'Locally advanced bladder cancer', 'Urothelial carcinoma', 'Locally advanced urothelial carcinoma', 'Metastatic urothelial carcinoma', 'avelumab', 'avelumab maintenance', 'Canada bladder cancer', 'Non-interventional study'], 'conditions': ['Urinary Bladder Neoplasms', 'Bladder Cancer', 'Bladder Tumors', 'Urothelial Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B9991053', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about the safety and effects of the study medicine (called avelumab) for the treatment of advanced bladder cancer.\n\nThis study is including participants who:\n\n* Participated in the Canadian avelumab patient support program\n* Have been diagnosed with advanced bladder cancer\n* Have been treated with platinum-based chemotherapy without their disease progressing All participants in this study have previously received avelumab first-line maintenance for the treatment of their advanced bladder cancer.\n\nPfizer will examine the experiences of people receiving the study medicine. This will help determine the efficacy and safety of the study medicine for the treatment of bladder cancer.', 'detailedDescription': 'Avelumab was approved by Health Canada in December 2020 for the maintenance treatment of patients with locally advanced/metastatic urothelial carcinoma (LA/mUC) whose disease has not progressed following first-line (1L) platinum-based chemotherapy. As the urothelial carcinoma treatment landscape evolves with novel indications for previously existing medicines and novel agents entering the market, additional insights are needed to assist in guiding treatment decision making. No observational studies of treatment patterns and outcomes for patients in Canada treated with avelumab first-line maintenance (1LM) have been conducted. The purpose of the current study is to conduct an analysis of patient and disease characteristics and treatment patterns to further elucidate the clinical effectiveness and impact of avelumab 1LM therapy for patients with LA/mUC in Canada.\n\nThe primary research objective is to assess effectiveness outcomes in a clinical setting for Canadian patients with LA/mUC treated with avelumab 1LM therapy, specifically overall survival (OS) from the date of avelumab 1LM initiation to the date of death from any cause and progression-free survival (PFS) from the date of avelumab 1LM initiation to the date of progression or death from any cause. Selected secondary objectives include describing treatment patterns, describe AEs explicitly attributed to avelumab among patients with LA/mUC treated with avelumab 1LM and response rates from date of avelumab 1LM initiation, and separately, from the date of chemotherapy initiation, and duration of response (DOR) from date of best overall response in each line of therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Canadian patients histologically diagnosed with stage IV LA/mUC and having participated in the avelumab patient-support program (PSP).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in the Canadian avelumab1LM Patient support program (PSP)\n* Histologically confirmed diagnosis of stage IV LA/mUC\n* No evidence of disease progression following first-line platinum-based chemotherapy\n* Receipt of avelumab1LM following 1L platinum-based chemotherapy\n* Received the last dose of chemotherapy no more than 10 weeks before entering the PSP\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* ≥6 months of follow-up from initiation of AVE 1LM therapy until study end date, unless the patient has died, with known date of death.\n\nExclusion Criteria:\n\n* Diagnosed with LA/mUC and enrolled in the PSP, but did not receive avelumab\n* Pregnancy at index date\n* Participation in an interventional clinical trial at any point during the study period\n\nThe index date will be considered as the initiation of index therapy. The index therapy will be considered as the avelumab 1LM treatment after 1L platinum-based chemotherapy.'}, 'identificationModule': {'nctId': 'NCT05699135', 'briefTitle': 'A Study to Learn About the Effect of Avelumab First-Line Maintenance in Canadian People With Advanced Bladder Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Treatment Effectiveness of Avelumab First-Line Maintenance Among Canadian Patients With Advanced Urothelial Carcinoma (TRAVELER)', 'orgStudyIdInfo': {'id': 'B9991053'}, 'secondaryIdInfos': [{'id': 'TRAVELER', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Canadian Patients with Advanced Urothelial Carcinoma', 'description': 'Patients with LA/mUC who following 4-6 cycles of platinum chemotherapy and have not progressed, received avelumab, recommended dose of 10mg/kg body weight intravenously administered over 60 minutes every 2 weeks', 'interventionNames': ['Drug: Avelumab first-line maintenance']}], 'interventions': [{'name': 'Avelumab first-line maintenance', 'type': 'DRUG', 'description': 'Patients with LA/mUC who following 4-6 cycles platinum chemotherapy and have not progressed, received avelumab, recommended dose of 10mg/kg body weight, intravenously administered over 60 minutes every 2 weeks', 'armGroupLabels': ['Canadian Patients with Advanced Urothelial Carcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L5K2L3', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Bayshore Specialty Rx', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}