Phase 3 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 clear cell or non-clear cell renal cell carcinoma (confirmed by a tissue sample/biopsy); people with collecting duct carcinoma cannot join.
• Your original kidney tumor is still in place (has not been removed yet).
• You have had specific scans (CT scan of the chest, and a CT or MRI of the abdomen and pelvis) showing that your cancer has spread to other parts of the body, completed within the required timeframes before joining.
• If your cancer has spread and is causing symptoms in specific areas, you may have received or be planning to receive radiation treatment to relieve those symptoms.
• You have no clear medical reason why you could not have kidney removal surgery (nephrectomy).
• You are willing to sign a consent form confirming you understand this is a research study.
• You are willing to allow tissue and/or blood samples to be collected and stored for research purposes (with your consent).
• For the second stage of the trial: after about 12 weeks of pre-trial treatment with immunotherapy drugs, your cancer has either stayed stable, partially responded (shrunk), or your doctor believes you are clearly benefiting from the treatment — but your cancer has not completely disappeared in all areas.
• For the second stage: you have received at least a minimum number of doses of one of the following immunotherapy treatments: nivolumab plus ipilimumab, pembrolizumab, or avelumab (confirm with trial site for exact dose numbers).
• For the second stage: you are generally well enough to be active and care for yourself (rated 0 or 1 on a standard medical fitness scale) within 28 days before joining the second stage.
• For the second stage: your liver and kidney function blood test results are within acceptable ranges within 28 days before joining the second stage (confirm with trial site for exact values).
• For the second stage: you have a surgery date planned within 42 days of joining the second stage, and a surgeon has confirmed you are a suitable candidate for surgery.

Who may not be able to join:

• You have active cancer that has spread to your brain; however, if brain metastases were previously treated and you have no current brain-related symptoms, you may still be eligible (confirm with trial site).
• If you have never received treatment before, you have already had any systemic (whole-body) drug treatment for your kidney cancer before joining; or if you have been previously treated, you have had more than one treatment regimen for your kidney cancer before joining.
• You have already received more than a set number of doses of the immunotherapy drugs intended as part of this trial before officially joining (confirm with trial site for exact limits).
• You have received any immunotherapy treatment for any cancer within the past year before joining the trial.
• You only have one kidney, or you have a transplanted kidney.
• You have another active cancer, unless it is a type that has been successfully treated, such as certain skin cancers, early-stage cancers, or any cancer you have been free of for at least two years.
• You have a pre-existing medical condition that makes immunotherapy treatment or kidney removal surgery unsafe for you.
• For the second stage: your primary kidney tumor has grown/worsened during the pre-trial treatment period (unless your doctor believes this may be a temporary and misleading response called "pseudo-progression").

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