Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-21 @ 10:40 AM
Study NCT ID:
NCT06586593
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Immunotherapy of Operable Metastatic Melanoma in Real Life (GCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 77}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-06', 'studyFirstSubmitDate': '2024-09-04', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete histological response', 'timeFrame': 'Day 1', 'description': 'Histological response rate on histological analysis of the resected specimen'}], 'secondaryOutcomes': [{'measure': 'Objectival response rate', 'timeFrame': 'Day 1', 'description': 'Objectival response rate on imaging'}, {'measure': 'Event-free survival', 'timeFrame': 'Month 12', 'description': 'An event is defined by progression of the disease or toxicity making surgery impossible, the impossibility of starting adjuvant treatment within 84 days following surgery, recurrence of melanoma after surgery or death.'}, {'measure': 'Disease Free Survival after surgery', 'timeFrame': 'Month 12'}, {'measure': 'Overall survival', 'timeFrame': 'Month 18'}, {'measure': 'Metastases-free survival', 'timeFrame': 'Month 18'}, {'measure': 'Frequency of toxicities', 'timeFrame': 'Month 12', 'description': 'According to Common Terminology Criteria for Adverse Events (CTCAE) v5, grades III and IV'}, {'measure': 'Severity of toxicities', 'timeFrame': 'Month 12', 'description': 'According to CTCAE v5, grades III and IV'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma Metastatic']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate efficacy and tolerance of real life neoadjuvant immunotherapy in advanced yet operable melanoma.\n\nThe complete histological response will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with operable metastatic melanoma (stade III or IV of AJCC) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with operable metastatic melanoma (stage III or IV of American Joint Committee on Cancer \\[AJCC\\] Stages CLassification) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4), even if surgery cancelled due to disease progression or complete response or patient\\'s refusal to be operated.\n* Efficacy of the neoadjuvant immunotherapy histologically of radiologically assessed\n\nExclusion Criteria:\n\n* Uveal melanoma'}, 'identificationModule': {'nctId': 'NCT06586593', 'acronym': 'NEOMEL', 'briefTitle': 'Neoadjuvant Immunotherapy of Operable Metastatic Melanoma in Real Life (GCC)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'ETUDE NEOMEL: TRAITEMENT NEOADJUVANT PAR IMMUNOTHERAPIE DU MELANOME METASTATIQUE OPERABLE EN VIE REELLE (GCC)', 'orgStudyIdInfo': {'id': '2023/758'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Operable metastatic melanoma', 'description': 'Operable metastatic melanoma'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charlée NARDIN, MD PhD', 'role': 'CONTACT', 'email': 'cnardin@chu-besancon.fr'}, {'name': 'CHarlée NARDIN, MD PhD', 'role': 'CONTACT'}], 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bobigny', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Boulogne-sur-Mer', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CH de Boulogne-sur-Mer', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'city': 'Clermont-Ferrand', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Lyon', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Centre de Lutte Contre le Cancer Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Saint-Herblain', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'ICO René Gauducheau', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Toulouse', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Institut Universitaire de Cancérologie de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Valence', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CH de Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}], 'centralContacts': [{'name': 'Charlée NARDIN, MD PhD', 'role': 'CONTACT', 'email': 'cnardin@chu-besancon.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}