Phase 2 Kidney Cancer Trial, Completed

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 have signed a written consent form agreeing 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 between 1 and 5 detectable metastases (areas where cancer has spread) that can be measured using standard imaging guidelines.
• People who have been confirmed through a tissue or cell sample to have kidney cancer (renal cell carcinoma) that has spread to other parts of the body.
• People who are either new to treatment or have previously received up to 2 rounds of systemic treatment (such as Pazopanib or Sunitinib), with no more than 5 total metastases throughout that time.
• People who have been assessed by a surgeon and considered suitable for a specialised radiation treatment called SABR (stereotactic ablative radiotherapy), either because surgery is not medically safe, not technically possible, or has been declined by the patient.
• People who have at least one metastasis that can technically be treated with SABR.
• People who are able to provide stored tissue from a previously biopsied kidney cancer lesion if available; a new biopsy taken up to 4 weeks before treatment may also be requested, but this is entirely optional.
• People with a general health status rated 0–2 on the ECOG scale, meaning they are fully active to capable of basic self-care (confirm with trial site).
• People whose blood test results show that their bone marrow, kidney, and liver are functioning at adequate levels — all tests must be done within 10 days of registration (confirm specific values with trial site).
• People who are expected to live for more than 12 months.
• People who are willing and able to attend all required appointments, treatments, and follow-up visits.
• Women of childbearing potential who receive a negative pregnancy test within 72 hours before starting the study treatment.
• Women of childbearing potential who are willing to use 2 forms of contraception, be surgically sterile, or abstain from heterosexual activity during the trial and for 120 days after the last dose of study treatment.
• Men who agree to use adequate contraception from the first dose of study treatment through 120 days after the last dose.

Who may not be able to join:

• People whose doctor determines that the speed and extent of cancer growth means they need to start targeted drug therapy (TKI) immediately.
• People who have previously received high-dose radiotherapy to an area that would need to be treated again in this trial, including areas involving the spine (confirm with trial site).
• People who have untreated or currently active cancer spread to the brain. People whose brain metastases have been fully removed or controlled with stereotactic radiotherapy may still be considered, as long as they are not taking steroid medications to manage symptoms.
• People who have evidence of cancer pressing on the spinal cord.
• People with a spinal instability score of 7 or higher, unless a neurosurgery team has reviewed the case and confirmed the spine is stable.
• People who need surgical fixation of a bone lesion to make it stable — this surgery would need to be completed before joining the trial.
• People who have been diagnosed with an immune system deficiency, or who have been taking steroid or other immune-suppressing medications within 7 days of registration.
• People with a known history of active tuberculosis (TB).
• People who have a known allergy or sensitivity to pembrolizumab or any of its ingredients.
• People who have received a type of cancer treatment called a monoclonal antibody within 4 weeks before registration, or who have not yet recovered from side effects of such treatment.
• People who have received chemotherapy, targeted drug therapy, or radiotherapy within 2 weeks before registration, or who have not yet recovered from side effects of those treatments. (Note: People with mild nerve-related side effects of grade 2 or lower may still be considered — confirm with trial site.)
• People who have another cancer that is currently growing or requires active treatment, with the exception of certain treated skin cancers or cervical cancer in situ.
• People with known active cancer spread to the brain or the lining around the brain (carcinomatous meningitis). People with previously treated and stable brain metastases may still be considered, provided specific conditions are met — confirm with trial site.
• People who have an active autoimmune disease that has required systemic medical treatment within the past 2 years. Hormone or other replacement therapies are not counted as systemic treatment.
• People who have a known history of, or currently active, non-infectious lung inflammation (pneumonitis).
• People who have an active infection currently requiring treatment with systemic medications.
• People who, in the opinion of the treating doctor, have any condition, treatment history, or test result that could interfere with the trial or would not be in their best interest to participate.
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial requirements.
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the trial period and for 120 days after the last dose of treatment.
• People who have previously been treated with certain types of immunotherapy drugs that target the PD-1 or PD-L1/PD-L2 pathways.
• People with a known history of HIV.
• People with known active Hepatitis B or Hepatitis C infection.
• People who have received a live vaccine within 30 days before registration.

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