Nivolumab plus cabozantinib for older adults with kidney cancer
Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation
PHASE4 · Gustave Roussy, Cancer Campus, Grand Paris · NCT06934057
This trial tests the combination of nivolumab and cabozantinib in people aged 70 and older with metastatic clear-cell kidney cancer to see how it is used and tolerated in routine care.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris (other) |
| Drugs / interventions | Nivolumab, Cabozantinib |
| Locations | 7 sites (Angers and 6 other locations) |
| Trial ID | NCT06934057 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 or older with confirmed advanced or metastatic clear-cell renal cell carcinoma, treatment-naive in the metastatic setting, with performance status 0–2 and ability to give informed consent and attend follow-up.
Not a fit: Patients younger than 70, those with non–clear-cell histology, prior systemic therapy in the metastatic setting, or poor performance status (>2) are unlikely to match the enrolled population and may not benefit from the study's findings.
Why it matters
Potential benefit: If successful, the project could clarify how the nivolumab–cabozantinib combination is tolerated and managed in older patients, helping clinicians optimize treatment and supportive care for this age group.
How similar studies have performed: The nivolumab–cabozantinib combination has shown efficacy in broader phase 3 trials of advanced renal cell carcinoma, but prospective real-world data specifically in a geriatric population are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Angers and 6 other locations
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Cancer, Renal Cell Cancer, renal cell carcinoma, kidney cancer, cabozantinib, nivolumab, elderly patients, geriatric population