Nivolumab plus cabozantinib for older adults with kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm cohort enrolling patients aged 70 or older with advanced or metastatic clear-cell renal cell carcinoma who have not received prior systemic therapy in the metastatic setting. Participants receive nivolumab combined with cabozantinib according to standard practice while undergoing a baseline geriatric evaluation (G-CODE). The protocol includes reinforced, multimodal follow-up involving medical oncologists, geriatricians, nursing staff, scheduled phone contacts, and optional pharmacological monitoring for cabozantinib. The primary aim is to document real-life exposure, safety, and care pathways in an older population rather than to compare treatments.

Why it matters

Who can join: the full rules

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

Where it's running

• Gustave Roussy
  Villejuif, France Recruiting
• 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

Study contacts

• Principal investigator: Maxime FRELAUT, MD — Gustave Roussy, Cancer Campus, Grand Paris
• Study coordinator: Maxime Frelaut, MD
• Email: Maxime.FRELAUT@gustaveroussy.fr
• Phone: +33 1 42 11 57 60

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.