PEAK-1 for advanced clear cell RCC
What is the Purpose of this Study?
The study has three parts called Screening, Treatment, and Follow up. Most people will be in the study for about 21 months, but the time may be shorter or longer. People are placed into groups by chance. Two people out of every three will get two medicines called casdatifan and cabozantinib. One person out of every three will get cabozantinib and a pill with no medicine. No one will know which group they are in. All medicines are taken by mouth once each day at home, and people write down each dose in a study diary. During the study, people will have regular blood tests, heart checks, and mouth exams. They will also have CT or MRI scans about every eight weeks for two years, then every twelve weeks. People will answer questionnaires about once a month. The study uses casdatifan, which is a new medicine being tested, and cabozantinib, which is already approved to treat this type of kidney cancer.
This study is for adults who have a type of kidney cancer called clear cell renal cell carcinoma. Their cancer has either spread or has not gone away even after earlier treatment.
Who Can Participate in the Study?
This study is for adults who have advanced clear cell kidney cancer that has spread or has not gone away after earlier treatment. People must have organs and bone marrow that are working well enough before joining the study. They also must have at least one tumor that can be measured on a scan.
What is Involved?
This study is checking to see if a new drug called casdatifan works safely and helps more when it is taken with another medicine called cabozantinib. Some people will get casdatifan with cabozantinib, and others will get a pill with no medicine plus cabozantinib. Casdatifan blocks a protein that helps tumors grow, so it may slow down the cancer. Cabozantinib is already approved to treat this type of kidney cancer.