Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma
Recruiting now · Phase 4
Conditions studied: Kidney Cancer, Renal Cell Cancer
In brief
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
Key facts
- Study ID
- NCT06934057
- Run by
- Gustave Roussy, Cancer Campus, Grand Paris
- People needed
- 50
- Starts
- 2025-05-16
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2025-09-24
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients ≥ 70 years-old
- Confirmed advanced or metastatic renal-cell carcinoma
- Patients not previously treated in metastatic setting
- Performance Status 0 to 2
- 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.
- 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.
- Patients must be affiliated to a social security system or beneficiary of the same
You may not qualify if…
- 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)
- Performance Status > 2
- 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)
- Any severe cardiovascular or thrombo-embolic event in the last three months
- Any situation for which exclusive palliative care intervention is recommended
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
Where it is running
- Gustave Roussy — Villejuif, France (enrolling)
- Centre Georges François Leclerc — Dijon, France
- Centre Léon Bérard — Lyon, France
- Institut de Cancérologie de l'Ouest - Angers — Angers, France
- Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud — Toulouse, France
- CHU Tours - Hôpital Bretonneau — Tours, France
- Hôpital Tenon — Paris, France
Full record on ClinicalTrials.gov
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