Phase 2 Kidney Cancer Trial, Recruiting

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

Who might be able to join this trial:

• You have been diagnosed with a type of kidney cancer called metastatic clear cell renal cell carcinoma, and it was first found less than 12 months ago
• You are 18 years of age or older
• Your cancer is considered lower risk based on a scoring system called the IMDC score (score of 0 or 1) (confirm with trial site)
• You have not previously had systemic (whole-body) treatment for this kidney cancer, although prior immunotherapy or targeted therapy after surgery may be allowed if your cancer came back at least 12 months after finishing that treatment
• Your cancer can be seen and measured on a CT or MRI scan
• You have signed the official consent form for the study
• You are generally in good physical health, able to carry out most normal activities (confirm with trial site)
• Your treating cancer doctor feels you are suitable for a period of active monitoring
• Your blood counts, liver function, and kidney function are within acceptable ranges (confirm with trial site)
• It has been at least 28 days since any major surgery
• You are able to swallow and digest oral (by mouth) medication
• Your blood oxygen level is above 92% while breathing normal room air
• If you are a woman who could become pregnant, you are not currently pregnant or breastfeeding, and you agree to use highly effective contraception during the study and for at least 30 days after the last dose, and you have a negative pregnancy test within 24 hours before starting treatment
• If you are a man, you agree to use contraception or remain abstinent during the study and for at least 7 days after the last dose
• You have or have had another type of cancer in the past, but it is unlikely to affect your safety or the results of this study

Who may not be able to join:

• You have cancer that has spread to the brain, or you have a condition called leptomeningeal disease (cancer around the brain or spinal cord)
• You currently need supplemental oxygen, either sometimes or all the time
• You have another serious medical condition that is not well controlled and could put you at risk or affect the study (confirm with trial site)
• You have a stomach or bowel problem that could affect how your body absorbs oral medication, such as severe nausea, vomiting, diarrhea, or inflammatory bowel disease
• You have had a serious heart or blood vessel event in the past 6 months, such as a heart attack, stroke, unstable chest pain, or severe heart failure
• You have received certain medications to boost blood cell production within the past 28 days before starting the study
• You have moderate or severe liver disease (confirm with trial site)
• You have had major surgery within the last 28 days, or radiation therapy within the last 2 weeks, or have not yet recovered from those treatments
• You have taken certain targeted cancer medicines or any HIF-2a blocking drug (a specific type of cancer drug) recently (confirm with trial site)
• You have a known allergy or sensitivity to the study drug (belzutifan) or any of its ingredients
• You are currently taking certain medications that affect how the body processes drugs (specific enzyme-affecting medicines) that cannot be stopped during the study (confirm with trial site)
• You have an active infection that requires treatment with antibiotics or antiviral medicines within the last 14 days
• You have active tuberculosis (TB)
• You have an active hepatitis B or hepatitis C infection
• You have any other condition or circumstance that the study doctor believes would make it unsafe or not in your best interest to participate
• You have HIV that is not well controlled (well-controlled HIV on treatment with a good immune cell count may be allowed — confirm with trial site)
• You are pregnant or currently breastfeeding

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