Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 6:01 AM
Study NCT ID:
NCT05361434
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2022-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 311}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-04-29', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.', 'timeFrame': 'At 18 months follow up'}], 'secondaryOutcomes': [{'measure': 'Tumor median progression-free survival (PFS) time', 'timeFrame': 'Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression', 'description': 'Including clinical and radiographic assessments defined as the time between the start date of cabozantinib in combination with nivolumab and the date of progression or death of any cause. The Kaplan-Meier method will be used to estimate median PFS.'}, {'measure': 'Proportion of participants who achieve partial or complete response (Objective Response Rate (ORR))', 'timeFrame': 'Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression', 'description': 'Assessed by the investigator'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression', 'description': 'Defined as the interval from the date of first response (complete or partial) to treatment with cabozantinib in combination with nivolumab, to progressive disease or death'}, {'measure': 'Proportion of participants who achieve complete response, partial response or stable disease (Disease Control Rate (DCR)).', 'timeFrame': 'Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression.'}, {'measure': 'Time of response (TTR)', 'timeFrame': 'Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression', 'description': 'Defined as the time between the start date of cabozantinib in combination with nivolumab and date of first response (complete or partial).'}, {'measure': 'Pattern of use of cabozantinib under real-world practice conditions.', 'timeFrame': 'Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression'}, {'measure': 'Pattern of use of nivolumab under real-world practice conditions.', 'timeFrame': 'Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression'}, {'measure': 'Incidence of treatment-emergent Adverse Events (TEAEs) including nonserious Adverse Events (AEs), and Serious Advers Events (SAEs).', 'timeFrame': 'Up to 42 months or disease progression', 'description': 'All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and will be classified by MedDRA PT and SOC.'}, {'measure': 'Change in disease-related symptoms', 'timeFrame': 'Change from baseline at each visit up to 42 months', 'description': 'Assessed by the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire'}, {'measure': 'Change in pain', 'timeFrame': 'Change from baseline at each visit up to 42 months', 'description': 'Assessed by the Numerical Pain Rating Scale (NPRS)'}, {'measure': 'Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation', 'timeFrame': 'Up to 42 months.', 'description': 'Including: Sequences of treatment; drug names and duration of treatment; and reason for end of treatment line'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '37403652', 'type': 'DERIVED', 'citation': 'Barthelemy P, Dutailly P, Qvick B, Perrot V, Verzoni E. CaboCombo: a prospective, phase IV study of first-line cabozantinib + nivolumab for advanced renal cell carcinoma. Future Oncol. 2024 Apr;20(13):811-819. doi: 10.2217/fon-2023-0353. Epub 2023 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with aRCC with clear cell-component, according to real-world clinical practice. The decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include participants with advanced renal cell carcinoma with clear cell component, for whom a decision to treat with cabozantinib and nivolumab in combination has been made by the treating physician', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with diagnosis of aRCC with clear-cell component\n* Participants with no prior systemic treatment for aRCC with clear-cell component;\n* Physician-initiated decision to treat with cabozantinib and nivolumab in combination (prior to study enrolment), according to Cabometyx® and Opdivo® approved local labels;\n\nExclusion Criteria:\n\n* Current participation in an investigational program with any intervention which could possibly interfere the treatment and impact this study;\n* History of allergy or hypersensitivity to Cabometyx® or Opdivo® components.'}, 'identificationModule': {'nctId': 'NCT05361434', 'acronym': 'CaboCombo', 'briefTitle': 'A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults', 'orgStudyIdInfo': {'id': 'CLIN-60000-452'}}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU St Pierre & Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Yvoir', 'country': 'Belgium', 'facility': 'CHU Namur Mont-Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'city': 'Angers', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire (CHU) de Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Ars-Laquenexy', 'country': 'France', 'facility': 'Hopital de Mercy- CHR Metz Thionville', 'geoPoint': {'lat': 49.09377, 'lon': 6.26989}}, {'city': 'Avignon', 'country': 'France', 'facility': 'Institut Ste Catherine - Institut du Cancer Avignon Provence', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Besançon', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Besançon - Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bezannes', 'country': 'France', 'facility': 'ICONE', 'geoPoint': {'lat': 49.22339, 'lon': 3.98892}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Groupe Hospitalier Saint-André (Bordeaux)', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Boulogne-sur-Mer', 'country': 'France', 'facility': 'Centre Hospitalier de Boulogne-sur-mer', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'city': 'Bourg-en-Bresse', 'country': 'France', 'facility': 'Centre Hospitalier Fleyriat', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'city': 'Brest', 'country': 'France', 'facility': "Centre Finisterien de Radiotherapie et d'Oncologie", 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Cabestany', 'country': 'France', 'facility': "Centre d'Urologie Site Médipole - 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