Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma

Phase 4

Recruiting

• Conditions: Kidney Cancer; Renal Cell Cancer
• Interventions: Drug: Nivolumab; Drug: Cabozantinib

• Registration Number: NCT06934057
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Study Timeline

• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-16
• Study First Posted: 2025-04-18
• Study Start: 2025-05-16
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-23
• Last Update Posted: 2025-09-24
• Primary Completion: 2028-04
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cabozantinib-Nivolumab	Nivolumab	The patient will be treated according to standard of care Nivolumab Cabozantinib.
Cabozantinib-Nivolumab	Cabozantinib	The patient will be treated according to standard of care Nivolumab Cabozantinib.

Primary Outcome Measures

Name	Time	Method
Dose modifications of Cabozantinib	24 weeks after treatment start	Primary outcome measure is treatment patterns, which includes the proportion of patients who experience any form of dose modification of Cabozantinib related to all grade toxicity within the first 24 weeks of treatment.
Starting dose of Cabozantinib	24 weeks after treatment start	Primary outcome measure is treatment patterns, which includes starting dose of cabozantinib.
Dose interruption of Cabozantinib	24 weeks after treatment start	Primary outcome measure is treatment patterns of Cabozantinib, which includes the proportion of patients who experience any temporary dose interruption within the first 24 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Overall response rate based on radiological evaluation	12 months after treatment start	Overall response rate based on best radiological response rate with local RECIST 1.1 evaluation observed in the 12 months of the study
Overall-survival	12 months after treatment start	Defined as the time between the date of inclusion and the date of death whatever the cause. Patients alive at the date of last follow-up visit will be censored at that date.
Frequency of adverse events according to PRO-CTCAE	12 months after treatment start	Tolerance is evaluated based on patients reports.
Progression free survival	12 months after treatment start	Progression free survival, defined by the time between inclusion date and the date of observation of a progression of the disease according to RECIST 1.1 or death of the patient (all causes combined) or date of last follow-up if the patient is alive without progression or lost to follow up.
Duration of response	12 months after treatment start	It is defined as the time from first radiological evidence of response (partial or complete response) to disease progression or death among patients who achieve complete or partial response.
Frequency of adverse events according to CTCAE V5	12 months after treatment start	Tolerance is evaluated based on physicians reports.
Quality of life - Patient-related outcomes - FACT-G	At baseline, and every 3 months after treatment start, up to 12 months after treatment start	Patients reported quality of life is evaluated based on Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. It is an 27 item questionnaire, ranging from 0 to 108 score. Higher scores indicate better quality of life
Quality of life - Patient-related outcomes - FACIT TS-G	Every 3 months after treatment start, up to 12 months after treatment start	Patients reported quality of life is evaluated based on Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT TS-G) questionnaire. The score range goes from 0 to 70 score. Higher scores indicate greater satisfaction with treatment

Trial Locations

Locations (7)

Institut de Cancérologie de l'Ouest - Angers; 🇫🇷 Angers, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Hôpital Tenon; 🇫🇷 Paris, France

Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud; 🇫🇷 Toulouse, France

CHU Tours - Hôpital Bretonneau; 🇫🇷 Tours, France

Gustave Roussy; 🇫🇷 Villejuif, France