Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age70+
SponsorGustave Roussy, Cancer Campus, Grand Paris
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients ≥ 70 years-old
Confirmed advanced or metastatic renal-cell carcinoma
Patients not previously treated in metastatic setting
Performance Status 0 to 2
Disqualifiers
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)
Performance Status > 2
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)
Any severe cardiovascular or thrombo-embolic event in the last three months
Trial design
Design model
Single group
Treatments tested in this trial
Nivolumab
DrugBriefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion.
Cabozantinib
DrugCabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Cabozantinib-NivolumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Starting dose of Cabozantinib
Primary outcome measure is treatment patterns, which includes starting dose of cabozantinib.
Time frame
24 weeks after treatment start2
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 start3
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 startSecondary outcomes
1
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 start2
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 start3
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.
Time frame
12 months after treatment start4
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 startSponsors and contacts
Click on the lead sponsor to view all of their trials.
Gustave Roussy, Cancer Campus, Grand Paris
Lead sponsor
Ipsen
Collaborator
Source ClinicalTrials.gov