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:

• People who are willing and able to give written consent to take part in the trial
• People who are 18 years of age or older at the time of signing the consent form
• People who have been diagnosed with kidney cancer (renal cell carcinoma) that has spread to other parts of the body, confirmed by a tissue sample (biopsy)
• People who are reasonably active and able to carry out daily activities, as measured by a standard medical scale called the ECOG scale (scores 0, 1, or 2) (confirm with trial site)
• People whose life expectancy is estimated to be more than 6 months
• People whose most recent cancer treatment included a type of drug called an immune checkpoint inhibitor (ICI), taken for at least 3 months before the cancer started growing again in a limited number of spots, with the last dose taken within the 3 months before joining the trial
• People whose cancer has grown or spread in only up to 5 specific spots (called "oligoprogression"), in areas that have not previously been treated with local therapy, as shown by specific changes on imaging scans (confirm with trial site for exact imaging criteria)
• People whose cancer may have spread to any total number of sites in the body — there is no upper limit on total metastases
• People whose blood, kidney, and liver test results meet the minimum levels required by the trial (blood tests must be done within 28 days of starting treatment; kidney and liver values only apply if the radiation treatment is aimed near those organs) (confirm with trial site for exact values)
• People who are able to receive a type of targeted radiation treatment called SBRT at a Yale radiation oncology facility
• Women who could become pregnant must have a negative pregnancy test (urine or blood) within 72 hours before the first radiation treatment
• Women who could become pregnant must use a highly effective form of birth control during the trial and for 120 days after the last dose of study treatment, started at least 30 days before the screening visit
• Men must agree to use an adequate form of contraception from the first treatment dose through 6 months after the last dose

Who may not be able to join:

• People who have received radiation therapy within 2 weeks before the first study treatment
• People whose cancer has only spread to the brain with no other sites of progression (people with cancer spread to both the brain and elsewhere in the body may still be considered, but brain treatment would need to happen first under standard care)
• People who have a diagnosed immune system deficiency, or who are currently taking steroid medications or other immune-suppressing drugs within 2 weeks of starting the trial (low-dose steroids for ongoing conditions, up to a certain daily amount, may be allowed — confirm with trial site)
• People who have another cancer that is currently growing or requires active treatment (some minor skin cancers or early-stage cervical cancer that has been treated may be exceptions — confirm with trial site)
• People who have an active autoimmune disease that has required systemic (whole-body) treatment in the past 3 months, or who have a history of a severe autoimmune condition requiring ongoing steroids or immune-suppressing medications (some conditions such as vitiligo, stable thyroid conditions on hormone replacement, or Sjögren's syndrome may be exceptions — confirm with trial site)
• People who have a history of lung inflammation (pneumonitis) that required steroid treatment, who currently have pneumonitis, or who have an underlying lung condition that the treating doctor considers makes them unsuitable
• People who have an active infection that requires treatment through the bloodstream (systemic therapy)
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial or within 120 days after the last treatment dose
• People who have active Hepatitis B or Hepatitis C infection
• People who have received a live vaccine within 30 days before the first study treatment
• People who have serious medical conditions that make radiation therapy unsafe, such as certain connective tissue diseases (for example, lupus or scleroderma), or Crohn's disease if the bowel area would be in the radiation field
• People whose proposed radiation treatment area substantially overlaps with an area that has previously been treated with radiation, unless the combined radiation dose can still meet safe limits (confirm with trial site)

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