IPSEN OBSERVATIONAL STUDY CABOZANTINIB aRCC
Research type
Research Study
Full title
A prospective observational international study of cabozantinib tablets in combination with nivolumab as first-line treatment of advanced renal cell carcinoma in adults
IRAS ID
315468
Contact name
Caroline Forde
Contact email
Sponsor organisation
Ipsen Pharma
Duration of Study in the UK
3 years, 6 months, days
Research summary
Renal cell carcinoma (RCC) accounts for approximately 90.0% of kidney cancers and around 3.0% of all cancers, with the highest incidence in the Western countries. During the last two decades, the incidence of RCC has been increasing by about 2.0% annually both worldwide and in the European Union (EU).
The EC approved cabozantinib (Cabometyx®) in combination with nivolumab (Opdivo®) for the first-line treatment of advanced RCC on 26 March 2021 based on the results of the pivotal phase 3 CheckMate 9ER trial.
Adult participants with aRCC with clear-cell component who will start first-line treatment with the combination of cabozantinib and nivolumab as part of routine/ standard clinical practice will be included in the study.
The aim is to provide effectiveness and safety data in adults with aRCC with clear-cell component treated with cabozantinib and nivolumab under real-world practice conditions.
The study will be conducted in approximately 70 centres worldwide in countries with a marketing authorisation and reimbursement, with a total of 311 participants.
The study will collect data at the Inclusion/Treatment initiation Visit, at Treatment Periods Visits and by phone call every 3 months during the Post-treatment Follow-up Period. Visits will be in accordance with routine clinical practice.No additional diagnostic or monitoring procedures will be applied to the participants and epidemiological methods will be used for the analysis of collected data.
Expected study duration is 42 months, and expected duration of the recruitment period is 24 months. Participants will be followed-up for the complete duration of the study (i.e. until death or the end of study, whichever comes first), if possible. The maximum duration of participation will vary from 18 months for the participant enrolled last to 42 months for the participant enrolled first.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0309
Date of REC Opinion
13 Sep 2022
REC opinion
Further Information Favourable Opinion