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:

• Adults aged 18 or older at the time of signing the consent form.
• People who are able to give their own informed consent, or who have a legally authorised representative who can do so on their behalf.
• People who have signed and dated the consent form approved by the ethics review board.
• People who are scheduled for kidney removal surgery for high-risk, non-metastatic clear cell kidney cancer — meaning the cancer has not spread beyond nearby lymph nodes, and based on imaging scans (CT and/or MRI), and where a recognised pre-surgery scoring tool estimates a 30% or greater chance of the cancer spreading within 12 years.
• People who have had a biopsy confirming the cancer is the clear cell type before treatment begins.
• People who have a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People whose blood test results from within the past 14 days show that the bone marrow, liver, and kidneys are working adequately — including sufficient blood cell counts, acceptable liver enzyme levels, and adequate kidney function (confirm specific numbers with trial site).

Who may not be able to join:

• People who have previously received any systemic (whole-body) treatment for kidney cancer.
• People who have previously received any immune checkpoint inhibitor therapy for any medical condition.
• People for whom the surgeon determines it is not safe to delay surgery by 9 weeks.
• People currently participating in another clinical trial involving an investigational treatment.
• People with a known allergy or serious sensitivity to any of the active ingredients or other components of the study drugs.
• People with a history of severe allergic reactions to any monoclonal antibody (a type of laboratory-made protein used as a medicine).
• People with uncontrolled ongoing illness, such as an active infection requiring treatment, uncontrolled heart failure, unstable chest pain, or uncontrolled irregular heartbeat.
• People with a history of inflammation of the heart muscle (myocarditis).
• People with significantly elevated levels of heart stress markers (troponin) in their blood at the start of the study (confirm specific thresholds with trial site).
• People with an active autoimmune disease, or a history of autoimmune disease within the past 2 years that could come back, affect vital organ function, or require immune-suppressing treatment — including conditions such as multiple sclerosis, lupus, inflammatory bowel disease, and certain others. Some milder autoimmune conditions (such as vitiligo, type 1 diabetes, or well-controlled thyroid conditions) may still be eligible (confirm with trial site).
• People who have needed steroid tablets or other immune-suppressing medicines within 14 days before starting the study drug. Topical, inhaled, or other locally applied steroids with minimal whole-body absorption are generally permitted.
• People diagnosed with another cancer within the past 2 years, except for certain minor skin cancers or low-grade localised cancers that were considered cured and did not require systemic treatment.
• People who have previously had a bone marrow transplant from a donor or a solid organ transplant (such as a kidney or liver transplant).
• People who have had a significant local or body-wide infection requiring antibiotic treatment within 2 weeks before the first dose.
• People who have received a live vaccine (such as chickenpox vaccine) within 30 days before starting the study treatment. Non-live vaccines (such as the flu shot) are generally permitted. Special timing rules apply to COVID-19 vaccines (confirm with trial site).
• People with uncontrolled HIV, hepatitis B, or hepatitis C infection, or a diagnosed immune deficiency linked to a chronic infection. People with these infections whose conditions are well-controlled under medical supervision may still be eligible (confirm with trial site).
• Women with a positive pregnancy blood test at the screening visit, unless an ultrasound rules out pregnancy.
• Women who are currently breastfeeding.
• Women who could become pregnant and are sexually active but are not willing to use highly effective contraception from before the first treatment, throughout the study, and for at least 6 months after the last dose.
• Male participants whose partners could become pregnant are required to use condoms throughout the study and for 6 months after the last dose, unless they have had a vasectomy or abstain from sex.
• Women who could become pregnant must agree not to donate eggs for assisted reproduction during the trial and for 6 months after the last dose.
• All male participants must agree not to donate sperm during the trial and for 6 months after the last dose.

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