Nivolumab: Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion.
Cabozantinib: Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day.
Study summary
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
Eligibility
Sex
ALL
Min age
70 Years
Max age
—
Healthy volunteers
No
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
Exclusion Criteria:
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
Primary outcome measure(s)
Starting dose of Cabozantinib — 24 weeks after treatment start Primary outcome measure is treatment patterns, which includes starting dose of cabozantinib.
Dose interruption of Cabozantinib — 24 weeks after treatment start 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.
Dose modifications of Cabozantinib — 24 weeks after treatment start 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.
Trial sites (7)
Facility
City
Region
Status
Institut de Cancérologie de l'Ouest - Angers
Angers
France
Not Yet Recruiting
Centre Georges François Leclerc
Dijon
France
Not Yet Recruiting
Centre Léon Bérard
Lyon
France
Not Yet Recruiting
Hôpital Tenon
Paris
France
Not Yet Recruiting
Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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