Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:21 AM
Study NCT ID:
NCT07338968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-14
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098943', 'term': 'Uveal Melanoma'}], 'ancestors': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2033-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events (AEs)/serious AEs.', 'timeFrame': '5 years', 'description': 'The AU-011-403 study is the long-term follow-up study of participants previously treated in AU-011-301.Long-term safety will be assessed by measuring the incidence of adverse events (AEs) and serious adverse events (SAEs) occurring during the follow-up period. AEs will be coded using the same Medical Dictionary for Regulatory Activities version used in AU-011-301 (MedDRA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ocular Melanoma', 'Small Choroidal Melanoma'], 'conditions': ['Choroidal Melanoma', 'Indeterminate Lesions']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.aurabiosciences.com', 'label': 'Aura Biosciences'}]}, 'descriptionModule': {'briefSummary': 'AU-011-403 is a multicenter long-term follow-up safety and efficacy study of subjects with early CM who previously participated in the AU-011-301 Phase 3 trial. There are no required interventions or use of AU-011 (bel-sar) in this long-term follow-up study', 'detailedDescription': "Informed consent will be obtained for each subject, preferably during their participation in the AU-011-301 trial and no more than approximately 6 months after their AU-011-301 End of Trial (EoT)/Early Termination (ET) visit. All subjects will be followed for an additional \\~5 years (not including AU-011-301 participation). The AU-011-301 assigned subject numbering will continue to be used in this study. The AU-011-301 randomization (treatment received) will continue to be masked during this study until the completion of the AU-011-301 trial and database lock. The purpose of this long-term follow-up study is to learn about how safe and how well bel-sar works over time in people who previously participated in the AU-011-301 study. This will include collecting data from both people who received bel-sar and those who received the sham procedure.\n\nThe AU-011-403 study will collect data on:\n\nLong-term safety will be measured by collecting information about any side effects (adverse events) or serious medical problems (serious adverse events) that may occur.\n\nLong-term effectiveness of treatment in AU-011-301 will be measured by looking at any changes in subject's early CM and/or changes in vision over time.\n\nDisease progression, including whether the early CM spreads to other parts of the body (metastasis).\n\nSurvival outcomes, including overall survival and disease-specific survival. Long-term quality of life (QoL) will be measured by using questionnaires (EORTC-QLQ-C30 and EORTC-QLQ-OPT30).\n\nThis study will help determine how long the effects of bel-sar last and whether any long-term risks or benefits appear after the initial treatment period.\n\nThe information collected may also help improve treatment options and strategies for future patients with early CM."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have received bel-sar or sham treatment in the Aura-sponsored clinical trial AU-011-301. NCT NCT06007690', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have received bel-sar or sham treatment in the Aura-sponsored clinical trial AU-011-301.\n* Be willing and able to consent to the AU-011-403 study.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT07338968', 'acronym': 'CoMpass', 'briefTitle': 'A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aura Biosciences'}, 'officialTitle': 'A Long-Term Follow-Up Study of Subjects Completing the AU-011-301 (CoMpass) Trial of Bel-sar for Early Choroidal Melanoma (Indeterminate Lesions/Small Choroidal Melanomas)', 'orgStudyIdInfo': {'id': 'AU-011-403'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'The intention is to collect data for an additional \\~5 years (Post AU-011-301 participation)'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Medical Monitor', 'role': 'CONTACT', 'email': 'clinical@aurabiosciences.com', 'phone': '617-500-8864'}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aura Biosciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aura Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}