A Phase II Randomized open label study with non clear Cell Renal Cell
Research type
Research Study
Full title
A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Sunitinib Monotherapy in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma
IRAS ID
221023
Contact name
Ekaterini Boleti
Contact email
Sponsor organisation
Goethe University Frankfurt
Eudract number
2016-000706-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Kidney Cancer (RCC) accounts for 3-4% of all cancers. It is considered the cancer with the worst outcomes of all genito-urinary cancers while its incidence has doubled over the past thirty years.
Clear cell carcinoma is the main type of kidney cancer which comprises approximately 70% of all kidney cancers. The rest are generally grouped together under the generic term of non-clear cell carcinomas of the kidney. They tend to have mostly more aggressive course and as a rule this group od kidney cancers is ot represented in all the major clinical trials. Results and outcomes are as a consequence extrapolated by the results taken from trials on clear cell kidney cancer patients.
It is therefore unclear if the treatments applied are the optimal for this types of kidney cancer or if new approaches need to be adopted for better outcomes.
It is recognised that mechanisms that regulate our immune system can influence the development, behaviour and progression of RCC. Over the past copule of years the role of immunotherapy in RCC has intensified and has demonstrated very promising results in the treatment of clear cell RCC. It is though still unclear if this type of novel therapy can provide similarly promising results in this varied group of RCC the non-clear cell RCCs.
This study addresses this unmet need by targeting for treatment patients with non-clear cell RCC.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0372
Date of REC Opinion
27 Mar 2018
REC opinion
Further Information Favourable Opinion