Clinical trial • Phase IV • Oncology

CABOZANTINIB for Advanced clear-cell renal cell carcinoma | Kidney cancer

Phase IV trial of CABOZANTINIB for Advanced clear-cell renal cell carcinoma | Kidney cancer. open-label. 83 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced clear-cell renal cell carcinoma | Kidney cancer
Trial Stage
Phase IV
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
26-02-2025
First CTIS Authorization Date
04-06-2025

Trial design

open-label Phase IV trial across 15 sites in France.

Open Label
Yes
Target Sample Size
83
Trial Duration For Participant
180

Eligibility

Recruits 83 Patients deprived of liberty or placed under the authority of a tutor are excluded ("Patient deprived of liberty or placed under the authority of a tutor"). Consent is required from the adult participant: "Patient has signed informed consents obtained before any trial related activities and according to local guidelines". No paediatric consent/assent procedures are specified..

Pregnancy Exclusion
Pregnant or lactating woman
Vulnerable Population
Patients deprived of liberty or placed under the authority of a tutor are excluded ("Patient deprived of liberty or placed under the authority of a tutor"). Consent is required from the adult participant: "Patient has signed informed consents obtained before any trial related activities and according to local guidelines". No paediatric consent/assent procedures are specified.

Inclusion criteria

  • {"criterion_text":"- Patient older than 18 years"}
  • {"criterion_text":"- Diagnosis of Renal Cell Carcinoma (RCC) with a clear-cell component"}
  • {"criterion_text":"- No prior systemic treatment for RCC"}
  • {"criterion_text":"- Physician-initiated decision prior to study enrollment to treat with cabozantinib and nivolumab in combination, according to approved local labels"}
  • {"criterion_text":"- Subjects affiliated to an appropriate social security system"}
  • {"criterion_text":"- Patient has signed informed consents obtained before any trial related activities and according to local guidelines"}

Exclusion criteria

  • {"criterion_text":"- Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol"}
  • {"criterion_text":"- Current participation in another clinical study and/or in an investigational program with any intervention that could possibly interfere with the treatment and impact this study"}
  • {"criterion_text":"- Patient with history of allergy or hypersensitivity to components of the study drugs"}
  • {"criterion_text":"- Patient with contraindication to the study drugs"}
  • {"criterion_text":"- Pregnant or lactating woman"}
  • {"criterion_text":"- Patient unable to use digital tools"}
  • {"criterion_text":"- Patient deprived of liberty or placed under the authority of a tutor"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint is the adjustment of treatments management including any unplanned action guided by weekly digital monitoring of PRO-CTCAEs: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment","definition_or_measurement_approach":"Measured by weekly digital monitoring of PRO-CTCAE self-reported symptoms; captured actions include anticipated consultation, anticipated phone follow-up, anticipated advice, treatment discontinuation and hospitalisation occurring within the first 3 months of the combined treatment."}

Recruitment

Planned Sample Size
83
Recruitment Window Months
30
Consent Approach
"Patient has signed informed consents obtained before any trial related activities and according to local guidelines". Subject information and informed consent forms for adults are provided (documents L1_SIS and ICF adults); translated materials and French translations are available in the submission. Adults provide consent; no paediatric assent described.

Geography

Total Number Of Sites
15
Total Number Of Participants
83

France

Latest Decision Or Authorization Date
11-12-2025
Number Of Sites
15
Number Of Participants
83

Sites

Site Name
Centre Antoine Lacassagne
Department Name
medical oncology
Contact Person Name
Nicolas MARTIN
Site Name
Centre Hospitalier De Boulogne Sur Mer
Department Name
medical oncology
Contact Person Name
claire CAPELLE
Contact Person Email
c.capelle@ch-boulogne.fr
Site Name
Centre d'Oncologie Saint-Yves
Department Name
oncologie médicale
Contact Person Name
Victor BASSE
Contact Person Email
vbasse@centre-st-yves.fr
Site Name
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name
oncologie médicale
Contact Person Name
Amina TABET
Contact Person Email
amina.tabet-zatla@ghrmsa.fr
Site Name
Institut Sainte Catherine
Department Name
oncologie médicale
Contact Person Name
Bertrand BILLEMONT
Contact Person Email
b.billemond@isc84.org
Site Name
Centre Hospitalier Annecy Genevois
Department Name
oncologie médicale
Contact Person Name
Mélodie CARBONNAUX
Site Name
Hospital Foch
Department Name
oncologie médicale
Contact Person Name
Yann-Alexandre VANO
Contact Person Email
y.vano@hopital-foch.com
Site Name
Groupe Hospitalier Bretagne Sud
Department Name
oncologie médicale
Contact Person Name
Marie L’HUISSIER
Contact Person Email
m.lhuissier@ghbs.bzh
Site Name
Groupe Hospitalier Public Du Sud De L Oise
Department Name
oncologie médicale
Contact Person Name
Elisabeth CAROLA
Contact Person Email
elisabeth.carola@ghpso.fr
Site Name
Polyclinique du Parc
Department Name
oncologie médicale
Contact Person Name
Maud VILLEMIN
Contact Person Email
m.villemin@ccpc-tubiana.fr
Site Name
Centre Leon Berard
Department Name
oncologie médicale
Contact Person Name
Armelle VINCENEUX
Site Name
Centre Hospitalier Aunay Bayeux
Department Name
oncologie médicale
Contact Person Name
Pierre-Emmanuel BRACHET
Contact Person Email
pe.brachet@ch-ab.fr
Site Name
Centre Francois Baclesse
Department Name
oncologie médicale
Contact Person Name
Romain LEVARD
Contact Person Email
r.levard@baclesse.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
oncologie médicale
Contact Person Name
Pierre CORNILLON
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
oncologie médicale
Contact Person Name
Mathilde CANCEL
Contact Person Email
m.cancel@chu-tours.fr

Sponsor

Primary sponsor

Full Name
Centre Francois Baclesse
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Third parties

  • {"country":"","full_name":"IPSEN PHARMA","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
CABOMETYX 40 mg film-coated tablets
Active Substance
CABOZANTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorised (EU marketing authorisation EU/1/16/1136/004)
Starting Dose
40 mg once daily
Dose Levels
40 mg
Frequency
once daily
Maximum Dose
40 mg per day
Investigational Product Name
OPDIVO 10 mg/mL concentrate for solution for infusion.
Active Substance
NIVOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
INFUSION (intravenous)
Route
intravenous infusion
Authorisation Status
Authorised (EU marketing authorisation EU/1/15/1014/001)
Starting Dose
240 mg intravenous every 2 weeks
Dose Levels
240 mg
Frequency
every 2 weeks
Maximum Dose
240 mg per dose
Combination Treatment
Yes

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