A Phase 3, open-label, randomised study of MK-6482 v Everolimus in RCC
Research type
Research Study
Full title
An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants with Advanced Renal Cell Carcinoma That Has Progressed After Prior PD- 1/L1 and VEGF-Targeted Therapies
IRAS ID
277125
Contact name
Naveed Sarwar
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc
Eudract number
2019-003444-72
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 8 months, 26 days
Research summary
Kidney cancers will be diagnosed in an estimated 400,000 patients worldwide each year and approximately 175,000 patients are expected to die of the disease.
Renal cell carcinoma (RCC), accounts for approximately 85% of all kidney cancers. A substantial proportion of patients with RCC progress to advanced stage disease; about one-third of patients cannot be treated with surgery or have secondary cancer growths at diagnosis, and between 20% to 30% of patients with localised tumours will eventually relapse after nephrectomy (removal of some or all the kidney).
Early-lines of treatment for patients with advanced RCC include drugs known as VEGF-targeting and immunotherapy agents. However, there is currently no evidence-based treatment recommendation for the optimal management of patients in the late-line setting (i.e. after immunotherapy and VEGF-targeting therapy). Under these circumstances, everolimus is commonly used in accordance with expert/clinical practice guidelines. Therefore, as patients rapidly progress on therapy in late-line settings, improved therapeutic options with superior efficacy are in great need.
MK-6482 is a small molecule that selectively and potently inhibits a protein called HIF-2α. HIF-2α is known to combine with HIF-1B to form a heterodimeric (2-protein) complex, which tumour cells can use to encourage the formation more of cancer cells.
The clinical study will investigate the effects of MK-6482 versus everolimus following PD-1/L1 immunotherapy and VEGF-targeted treatment on approximately 730 participants worldwide with advanced RCC. Eligible participants will be randomised in a 1:1 ratio to receive either MK-6482 or everolimus. The study will be carried out in 8 sites in the UK and will take approximately 4 years to complete. The study is funded by Merck Sharp & Dohme Limited.
REC name
London - Hampstead Research Ethics Committee
REC reference
20/LO/0197
Date of REC Opinion
11 Mar 2020
REC opinion
Favourable Opinion