Phase 3 Study of Belzutifan plus Pembrolizumab vs Placebo plus Pembrolizumab in Renal Cell Carcinoma
Research type
Research Study
Full title
A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)
IRAS ID
1004505
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eudract number
2021-003436-92
Clinicaltrials.gov Identifier
Research summary
Kidney cancer accounts for 5% and 3% of all adult cancers in men and women, respectively, representing the seventh most common cancer in men and the tenth most common cancer in women. Worldwide, there are an estimated 431,288 newly diagnosed cases of kidney cancer and an estimated 179,368 deaths per year. Genetic conditions, such as von Hippel-Lindau disease, predispose patients to having an increased risk of developing RCC. The incidence of RCC is continually increasing. Patients diagnosed are managed with nephron sparing (removal of cancerous tumour and leaves in as much healthy kidney tissue as possible) or total removal of the kidney – nephrectomy surgery. However, a significant percentage of patients will develop recurrent disease and eventually die of RCC. Most patients with intermediate-high or high-risk lesions experience recurrence within 2/3 years following surgery. Currently, there is no globally accepted standard of care in adjuvant RCC. Belzutifan is a potent and selective inhibitor of HIF-2α, established as a cancer driver in clear cell renal cell carcinoma (ccRCC). HIF-2α is a transcription factor, playing a critical role in the formation of tumour, tumour progression, and inactivation of VHL expression found in many cancers. When VHL, a tumour-suppressor protein, is inactivated, HIF-2α, can accumulate. KEYTRUDA® (pembrolizumab) has an acceptable safety profile and is in clinical development as an IV immunotherapy for advanced cancers. Combination of pembrolizumab (an anti-PD-1 antibody) with belzutifan may enhance therapeutic benefit in patients. Approximately 1,600 eligible participants will be randomised into a 1:1 ratio, to either belzutifan plus pembrolizumab administered by IV infusion every 6 weeks or oral placebo plus pembrolizumab administered by IV infusion every 6 weeks. The trial will last for approximately 8 years which includes a Screening, Treatment and Post-Treatment Follow-up Phase. The trial will take place at 8 trial centres in UK.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0044
Date of REC Opinion
16 Mar 2022
REC opinion
Further Information Favourable Opinion