This study compares the efficacy and safety of belzutifan + lenvatinib with that of cabozantinib in participants with advanced renal cell carcinoma (RCC) with a clear cell component after prior therapy.
Aim of the study
The study is testing MK-6482 (also known as belzutifan) + lenvatinib in participants with advanced renal cell carcinoma (RCC) with a clear cell component who have progressed after treatment. We are doing this study to assess the safety of MK-6482 + lenvatinib compared to cabozantinib, to investigate how well participants tolerate MK-6482 + lenvatinib compared to cabozantinib, and to find out if either treatment group has a longer life expectancy.
Who can take part?
Patients with advanced renal cell carcinoma (RCC)
Procedure
Medical data, blood and urine samples are recorded or taken during the course of the study. You will be physically examined and your vital signs will be measured. An electrocardiogram (ECG) and imaging examinations (CT, MRI) can also be carried out. Any side effects you have experienced will also be recorded. The study is divided into 3 phases. The total duration of your participation in this study depends on how much time you spend in each phase. During the screening phase, you must visit the study center one or more times. During the treatment phase, you will need to visit the study center about once a week for the first 3 to 4 weeks, then once every other week for weeks 5 to 9, and finally once every 4 weeks for the remainder of your time in this phase (until your cancer progresses, you start another cancer treatment, or your participation in the study ends). During the follow-up phase, you will have to visit the study center one or more times and will then be contacted by telephone every 12 weeks and asked about your health.
Compensation
None
Original study name
An open-label, randomized phase 3 study of MK-6482 in combination with lenvatinib (MK-7902) versus cabozantinib in participants with advanced renal cell carcinoma who progressed after prior anti-PD-1/L1 therapy
BASEC number
2020-02492
Financial support from
Merck Sharp & Dohme