Clinical trial NCT06934057: Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma
Official title: Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Kidney Cancer
Renal Cell Cancer
Keywords: renal cell carcinoma
kidney cancer
cabozantinib
nivolumab
elderly patients
geriatric population
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2025-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 inclusion, and a multimodal and reinforced follow-up, including medical oncologist, geriatrician nurse of doctor, phone calls, and optional pharmacological follow-up for Cabozantinib.

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

Primary outcomes:
measure: Starting dose of Cabozantinib
timeFrame: 24 weeks after treatment start
measure: Dose interruption of Cabozantinib
timeFrame: 24 weeks after treatment start
measure: Dose modifications of Cabozantinib
timeFrame: 24 weeks after treatment start
Secondary outcomes:
measure: Overall response rate based on radiological evaluation
timeFrame: 12 months after treatment start
measure: Overall-survival
timeFrame: 12 months after treatment start
measure: Progression free survival
timeFrame: 12 months after treatment start
measure: Duration of response
timeFrame: 12 months after treatment start
measure: Frequency of adverse events according to CTCAE V5
timeFrame: 12 months after treatment start
measure: Frequency of adverse events according to PRO-CTCAE
timeFrame: 12 months after treatment start
measure: Quality of life - Patient-related outcomes - FACT-G
timeFrame: At baseline, and every 3 months after treatment start, up to 12 months after treatment start
measure: Quality of life - Patient-related outcomes - FACIT TS-G
timeFrame: Every 3 months after treatment start, up to 12 months after treatment start
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest - Angers
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lyon
country: France
facility: Centre Léon Bérard
city: Paris
country: France
facility: Hôpital Tenon
city: Toulouse
country: France
facility: Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud
city: Tours
country: France
facility: CHU Tours - Hôpital Bretonneau
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Maxime FRELAUT, MD
role: PRINCIPAL_INVESTIGATOR
References: