Informations générales (source: ClinicalTrials.gov)
Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation
Interventional
Phase 4
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
avril 2025
avril 2028
24 septembre 2025
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Maxime FRELAUT | 21/04/2026 15:50:06 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Tenon | Djamel GHEBRIOU, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Georges François Leclerc - 21079 - Dijon - France | Leila BENGRINE, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69373 - Lyon - France | Helen BOYLE, MD | Contact (sur clinicalTrials) | |||
| CHU Tours - Hôpital Bretonneau - 37044 - Tours - France | Mathilde CANCEL, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Angers - 49055 - Angers - France | Elouen BOUGHALEM, MD | Contact (sur clinicalTrials) | |||
| Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud - 31059 - Toulouse - France | Loïc MOUREY, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Patients ≥ 70 years-old
2. Confirmed advanced or metastatic renal-cell carcinoma
3. Patients not previously treated in metastatic setting
4. Performance Status 0 to 2
5. 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.
6. 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.
7. Patients must be affiliated to a social security system or beneficiary of the same
1. Patients ≥ 70 years-old
2. Confirmed advanced or metastatic renal-cell carcinoma
3. Patients not previously treated in metastatic setting
4. Performance Status 0 to 2
5. 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.
6. 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.
7. Patients must be affiliated to a social security system or beneficiary of the same
1. 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)
2. Performance Status > 2
3. 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)
4. Any severe cardiovascular or thrombo-embolic event in the last three months
5. Any situation for which exclusive palliative care intervention is recommended
6. Patient under guardianship or deprived of his liberty by a judicial or
administrative decision or incapable of giving its consent