Phase 2 Kidney Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been confirmed by tissue testing to have a type of kidney cancer (renal cell carcinoma with clear cell component) that cannot be removed by surgery and has either spread locally or to other parts of the body
• People who have not had any previous systemic (whole-body) treatments for their advanced kidney cancer, except for a specific type of immunotherapy called anti-PD-(L)1 therapy given after surgery (adjuvant therapy)
• People whose cancer came back either during that post-surgery immunotherapy or within 24 months after the last dose of it
• People who are able to swallow tablets or capsules
• People who are able to provide either a stored tumour tissue sample or a new tissue biopsy from a tumour that has not previously been treated with radiation
• People receiving bone-strengthening therapy, provided that therapy was started at least 2 weeks before joining the trial
• People whose blood pressure is at or below 140/90 mmHg and has been stable on the same blood pressure medications for at least 1 week before joining the trial
• People whose heart, liver, kidneys, and other organs are functioning at an adequate level (confirm with trial site for specific thresholds)

Who may not be able to join:

• People who have had clinically significant bleeding, such as more than 2.5 mL of blood in urine, vomit, or coughed up, or a history of other serious bleeding episodes
• People who have had a significant heart or blood vessel condition within the 12 months before starting the trial
• People who have had a deep vein blood clot (DVT) within the 3 months before joining, unless it is stable, causing no symptoms, and has been treated with blood-thinning medication for at least 4 weeks
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, or currently active lung inflammation (pneumonitis)
• People who have a serious unhealed wound, active ulcer, or bone fracture, or who have had major surgery within 8 weeks before starting the trial
• People who have had fluid build-up around the lungs, abdomen, or heart that required draining in the 4 weeks before joining
• People with bowel or digestive tract disorders that carry a high risk of perforation or abnormal connections forming (fistulas)
• People who have trouble absorbing nutrients due to previous bowel surgery or a digestive disease
• People with moderate to severe liver impairment
• People who have received certain white blood cell–stimulating medications (colony-stimulating factors) within 28 days before joining
• People who have received radiation therapy within 2 weeks of starting the trial, or who have ongoing side effects from radiation that require steroid treatment
• People who are currently taking certain strong medications that affect how the body processes drugs (strong CYP3A4 inhibitors) and cannot stop taking them for the duration of the trial
• People who have received a live or live-attenuated vaccine within 30 days before the first dose of the trial treatment
• People who are currently on blood-thinning or anti-clotting medications that cannot be stopped for the duration of the trial
• People who have previously been enrolled in any part of the related study protocol MK-3475-U03
• People who have another cancer that is currently progressing or has required active treatment within the past 3 years
• People with active cancer that has spread to the brain or the lining around the brain or spinal cord
• People whose scans show that the tumour is wrapped around or growing into a major blood vessel, or that there are hollow cavities forming inside the tumour
• People with an active autoimmune disease that has required systemic treatment at any point in the past 2 years
• People with an active infection that requires systemic treatment
• People with a known history of HIV infection
• People with active hepatitis B or hepatitis C infection

Important: Always verify eligibility with the trial site directly before applying.