NCT06934057 Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma
| NCT ID | NCT06934057 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Condition | Kidney Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-16 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2025-05-16 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Maxime FRELAUT, MD
PRINCIPAL INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Frequently Asked Questions
Who can join the NCT06934057 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Kidney Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06934057 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06934057 currently recruiting?
Yes, NCT06934057 is actively recruiting participants. Contact the research team at Maxime.FRELAUT@gustaveroussy.fr for enrollment information.
Where is the NCT06934057 trial being conducted?
This trial is being conducted at Angers, France, Dijon, France, Lyon, France, Paris, France and 3 additional locations.
Who is sponsoring the NCT06934057 clinical trial?
NCT06934057 is sponsored by Gustave Roussy, Cancer Campus, Grand Paris. The principal investigator is Maxime FRELAUT, MD at Gustave Roussy, Cancer Campus, Grand Paris. The trial plans to enroll 50 participants.
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