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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion.
Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day.
Institut de Cancérologie de l'Ouest - Angers
Angers, France
NOT_YET_RECRUITINGCentre Georges François Leclerc
Dijon, France
NOT_YET_RECRUITINGCentre Léon Bérard
Lyon, France
Starting dose of Cabozantinib
Primary outcome measure is treatment patterns, which includes starting dose of cabozantinib.
Time frame: 24 weeks after treatment start
Dose interruption of Cabozantinib
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.
Time frame: 24 weeks after treatment start
Dose modifications of Cabozantinib
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.
Time frame: 24 weeks after treatment start
Overall response rate based on radiological evaluation
Overall response rate based on best radiological response rate with local RECIST 1.1 evaluation observed in the 12 months of the study
Time frame: 12 months after treatment start
Overall-survival
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.
Time frame: 12 months after treatment start
Progression free survival
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.
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Hôpital Tenon
Paris, France
NOT_YET_RECRUITINGInstitut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud
Toulouse, France
NOT_YET_RECRUITINGCHU Tours - Hôpital Bretonneau
Tours, France
NOT_YET_RECRUITINGGustave Roussy
Villejuif, France
RECRUITINGTime frame: 12 months after treatment start
Duration of response
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.
Time frame: 12 months after treatment start
Frequency of adverse events according to CTCAE V5
Tolerance is evaluated based on physicians reports.
Time frame: 12 months after treatment start
Frequency of adverse events according to PRO-CTCAE
Tolerance is evaluated based on patients reports.
Time frame: 12 months after treatment start
Quality of life - Patient-related outcomes - FACT-G
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
Time frame: At baseline, and every 3 months after treatment start, up to 12 months after treatment start
Quality of life - Patient-related outcomes - FACIT TS-G
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
Time frame: Every 3 months after treatment start, up to 12 months after treatment start