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Clinical Trials in France / NCT06934057
Recruiting Phase 4

Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma

NCT06934057 · tracked via the Priya Life Science France tracker
Phase
Phase 4
Started
2025-05-16
Last updated
2025-09-24

Condition(s) studied

Kidney CancerRenal Cell Cancer

Investigational drug(s) / intervention(s)

Nivolumab →Cabozantinib →

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)

Trial sites (7)

FacilityCityRegionStatus
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 Toulouse France Not Yet Recruiting
CHU Tours - Hôpital Bretonneau Tours France Not Yet Recruiting
Gustave Roussy Villejuif France Recruiting

On this site

📄 Opdivo (nivolumab) drug profile → 📄 Cabometyx (cabozantinib) drug profile →

More Gustave Roussy, Cancer Campus, Grand Paris trials in France

Other trials for the same condition

Official registry record

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.

View NCT06934057 on ClinicalTrials.gov ↗ ← All trials in France