Phase 3 Study of Belzutifan in Combination With Lenvatinib Versus Cabozantinib for Treatment of RCC
Research type
Research Study
Full title
An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy
IRAS ID
1003737
Contact name
Erin Collins
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eudract number
2020-002075-35
Clinicaltrials.gov Identifier
Research summary
Despite advances in the treatment of advanced renal cell carcinoma (RCC) in recent years, there remains an unmet need to improve outcomes for first and second line + advanced RCC populations. There is no standard of care for post anti-programmed death-1/ligand-1 (PD-1/L1) inhibitors second line + advanced RCC, and there are no large randomised clinical studies in this setting.
This is an open-label, randomised, phase 3 evaluating the efficacy and safety of the hypoxia-inducible factor (HIF-2α) inhibitor, belzutifan (MK-6482, previously known as PT2977), in combination with lenvatinib, versus cabozantinib as second or third-line treatment in participants with RCC with clear cell component.
MK-6482 (belzutifan) is an orally available, small molecule inhibitor of HIF-2α. It is being studied by the Sponsor to treat advanced solid tumors and Von-Hippel Lindau (VHL) disease-associated localised renal cell carcinoma (RCC). MK-6482 has not been approved to use alone or with other drugs to treat advanced clear cell RCC (ccRCC).
Lenvatinib is a receptor tyrosine kinase inhibitors (RTKIs). Tyrosine kinases are proteins that can be present in high amounts in cancer cells, so blocking their action may reduce cancer cellular growth and limit the cancer’s blood supply. Lenvatinib has been approved to treat different types of cancer including some types of kidney cancer. It has not been approved to use with MK-6482 to treat advanced ccRCC.
Cabozantinib is a standard treatment for ccRCC.
A total of 708 participants will be recruited, whose cancer has progressed after PD-1/L1 therapy, and randomised in a 1:1 ratio to receive either belzutifan + lenvatinib or cabozantinib daily until disease progression or treatment discontinuation. The Sponsor estimates that the study will last approximately 4 years.
This study is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (“MSD”), of Kenilworth, New Jersey, USA.
REC name
HSC REC A
REC reference
22/NI/0020
Date of REC Opinion
11 Feb 2022
REC opinion
Favourable Opinion