Status:
RECRUITING
Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborating Sponsors:
Ipsen
Conditions:
Kidney Cancer
Renal Cell Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE4
Brief 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
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06934057
Start Date
May 16 2025
End Date
April 1 2028
Last Update
September 24 2025
Active Locations (7)
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1
Institut de Cancérologie de l'Ouest - Angers
Angers, France, 49055
2
Centre Georges François Leclerc
Dijon, France, 21079
3
Centre Léon Bérard
Lyon, France, 69373
4
Hôpital Tenon
Paris, France, 75020