Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-30 @ 9:42 AM
Study NCT ID:
NCT06934057
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal 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': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'C558660', 'term': 'cabozantinib'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-16', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Starting dose of Cabozantinib', 'timeFrame': '24 weeks after treatment start', 'description': 'Primary outcome measure is treatment patterns, which includes starting dose of cabozantinib.'}, {'measure': 'Dose interruption of Cabozantinib', 'timeFrame': '24 weeks after treatment start', 'description': 'Primary outcome measure is treatment patterns of Cabozantinib, which includes the proportion of patients who experience any temporary dose interruption within the first 24 weeks of treatment.'}, {'measure': 'Dose modifications of Cabozantinib', 'timeFrame': '24 weeks after treatment start', 'description': 'Primary outcome measure is treatment patterns, which includes the proportion of patients who experience any form of dose modification of Cabozantinib related to all grade toxicity within the first 24 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Overall response rate based on radiological evaluation', 'timeFrame': '12 months after treatment start', 'description': 'Overall response rate based on best radiological response rate with local RECIST 1.1 evaluation observed in the 12 months of the study'}, {'measure': 'Overall-survival', 'timeFrame': '12 months after treatment start', 'description': 'Defined as the time between the date of inclusion and the date of death whatever the cause. Patients alive at the date of last follow-up visit will be censored at that date.'}, {'measure': 'Progression free survival', 'timeFrame': '12 months after treatment start', 'description': 'Progression free survival, defined by the time between inclusion date and the date of observation of a progression of the disease according to RECIST 1.1 or death of the patient (all causes combined) or date of last follow-up if the patient is alive without progression or lost to follow up.'}, {'measure': 'Duration of response', 'timeFrame': '12 months after treatment start', 'description': 'It is defined as the time from first radiological evidence of response (partial or complete response) to disease progression or death among patients who achieve complete or partial response.'}, {'measure': 'Frequency of adverse events according to CTCAE V5', 'timeFrame': '12 months after treatment start', 'description': 'Tolerance is evaluated based on physicians reports.'}, {'measure': 'Frequency of adverse events according to PRO-CTCAE', 'timeFrame': '12 months after treatment start', 'description': 'Tolerance is evaluated based on patients reports.'}, {'measure': 'Quality of life - Patient-related outcomes - FACT-G', 'timeFrame': 'At baseline, and every 3 months after treatment start, up to 12 months after treatment start', 'description': 'Patients reported quality of life is evaluated based on Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. It is an 27 item questionnaire, ranging from 0 to 108 score. Higher scores indicate better quality of life'}, {'measure': 'Quality of life - Patient-related outcomes - FACIT TS-G', 'timeFrame': 'Every 3 months after treatment start, up to 12 months after treatment start', 'description': 'Patients reported quality of life is evaluated based on Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT TS-G) questionnaire. The score range goes from 0 to 70 score. Higher scores indicate greater satisfaction with treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['renal cell carcinoma', 'kidney cancer', 'cabozantinib', 'nivolumab', 'elderly patients', 'geriatric population'], 'conditions': ['Kidney Cancer', 'Renal Cell Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to describe real-life use and exposition to nivolumab-cabozantinib among older patients with metastatic clear-cell renal cell cancer', 'detailedDescription': 'This study will be a prospective, multicentric, single-arm cohort. Patients will receive Nivolumab-Cabozantinib association per standard. All patients will benefit of geriatric evaluation (G-CODE) at inclusion, and a multimodal and reinforced follow-up, including medical oncologist, geriatrician nurse of doctor, phone calls, and optional pharmacological follow-up for Cabozantinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients ≥ 70 years-old\n2. Confirmed advanced or metastatic renal-cell carcinoma\n3. Patients not previously treated in metastatic setting\n4. Performance Status 0 to 2\n5. Sexually active male patients must agree to use condom during the study and for at least 5 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.\n6. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n7. Patients must be affiliated to a social security system or beneficiary of the same\n\nExclusion Criteria:\n\n1. Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (Patients may be included in CABOLD if they are included in the arm B of CARE1 study EUCT N° 2023-503317-29-00)\n2. Performance Status \\> 2\n3. Any condition that represent a contraindication to Cabozantinib and/or Nivolumab, as described in summaries of products characteristics, including symptomatic untreated brain metastasis or active auto-immune disease requiring systemic immunosuppressant/modulator (thyroid or adrenal disorder are not an exclusion criteria)\n4. Any severe cardiovascular or thrombo-embolic event in the last three months\n5. Any situation for which exclusive palliative care intervention is recommended\n6. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent'}, 'identificationModule': {'nctId': 'NCT06934057', 'acronym': 'CABOLD', 'briefTitle': 'Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation', 'orgStudyIdInfo': {'id': '2024-516650-22-00'}, 'secondaryIdInfos': [{'id': '2024/3873', 'type': 'OTHER', 'domain': 'CSET number (Gustave Roussy ID)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cabozantinib-Nivolumab', 'description': 'The patient will be treated according to standard of care Nivolumab Cabozantinib.', 'interventionNames': ['Drug: Nivolumab', 'Drug: Cabozantinib']}], 'interventions': [{'name': 'Nivolumab', 'type': 'DRUG', 'otherNames': ['OPDIVO'], 'description': 'Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion.', 'armGroupLabels': ['Cabozantinib-Nivolumab']}, {'name': 'Cabozantinib', 'type': 'DRUG', 'otherNames': ['CABOMETYX'], 'description': 'Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day.', 'armGroupLabels': ['Cabozantinib-Nivolumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49055', 'city': 'Angers', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elouen BOUGHALEM, MD', 'role': 'CONTACT', 'email': 'Elouen.boughalem@ico.unicancer.fr', 'phone': '+33 2 41 35 27 00'}], 'facility': "Institut de Cancérologie de l'Ouest - Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '21079', 'city': 'Dijon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Leila BENGRINE, MD', 'role': 'CONTACT', 'email': 'lbengrine@cgfl.fr', 'phone': '+33 380737528'}], 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '69373', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Helen BOYLE, MD', 'role': 'CONTACT', 'email': 'helen.boyle@lyon.unicancer.fr', 'phone': '+33 426556752'}], 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75020', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Djamel GHEBRIOU, MD', 'role': 'CONTACT', 'email': 'djamel.ghebriou@aphp.fr', 'phone': '+33 156017724'}], 'facility': 'Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Loïc MOUREY, MD', 'role': 'CONTACT', 'email': 'mourey.loic@iuct-oncopole.fr', 'phone': '+33 531155156'}], 'facility': 'Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathilde CANCEL, MD', 'role': 'CONTACT', 'email': 'm.cancel@chu-tours.fr', 'phone': '+33 2 47 47 99 99'}], 'facility': 'CHU Tours - Hôpital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '94800', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maxime FRELAUT, MD', 'role': 'CONTACT', 'email': 'Maxime.frelaut@gustaveroussy.fr', 'phone': '+33 142115760'}], 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Maxime Frelaut, MD', 'role': 'CONTACT', 'email': 'Maxime.FRELAUT@gustaveroussy.fr', 'phone': '+33 1 42 11 57 60'}, {'name': 'Maia Claveau CLAVEAU', 'role': 'CONTACT', 'email': 'maia.claveau@gustaveroussy.fr', 'phone': '+33 1 42 11 53 49'}], 'overallOfficials': [{'name': 'Maxime FRELAUT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ipsen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}