Study on Abemaciclib and Cabozantinib for People with Advanced Kidney Cancer

Inclusion Criteria

• Must be 18 years or older.
• Able to provide informed consent or have a legal representative to do so.
• Have a confirmed diagnosis of advanced clear cell renal cell carcinoma (ccRCC).
• Must have tissue samples available for diagnosis, but can still join the study if samples are unavailable with confirmation from the study leader.
• Have at least one measurable tumor outside of bones and the brain.
• Have a performance status score of 2 or less, indicating ability to carry out daily activities.
• Have tried at least two but no more than three previous treatments for advanced cancer.
• Have previously been treated with PD-1 or PD-L1 and VEGFR therapies.
• Have recovered from side effects of previous treatments to a mild level.
• Have completed and recovered from any recent radiation therapy.
• Able to swallow pills.
• Have adequate blood and organ function based on specific lab tests.
• Women of childbearing potential must not be pregnant or breastfeeding and must use effective birth control during the study and for four months after.
• Men must agree to use contraception and not donate sperm during the study and for four months after.

Exclusion Criteria

• Have previously been treated with abemaciclib or cabozantinib.
• Have received certain cancer treatments or investigational drugs recently.
• Have brain metastases requiring steroids, unless stable and treated.
• Have had another cancer within the last two years, except for certain skin cancers or early-stage cancers treated with curative intent.
• Require certain medications that affect drug metabolism.
• Have uncontrolled infections like HIV, hepatitis B, or hepatitis C.
• Have significant heart problems or uncontrolled high blood pressure.
• Have had recent significant arterial disease or heart events.
• Have certain bleeding disorders or recent significant bleeding.
• Have uncontrolled fluid buildup in the body.
• Have had major surgery recently without complete healing.
• Have gastrointestinal issues that could interfere with the study.
• Have active COVID-19 unless recovered for at least 30 days.
• Have allergies to study drugs.
• Have had recent radiation therapy for bone metastasis or systemic radionuclide treatment.
• Have other serious medical conditions that could interfere with the study.