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 participate
• People aged 18 or older
• People who have been confirmed, through tissue testing and imaging scans, to have kidney cancer (renal cell carcinoma) that falls into one of these categories: a larger tumour with no spread to lymph nodes or other organs but with high-grade or aggressive features; a tumour that has grown beyond the kidney with no spread to lymph nodes or other organs; cancer that has spread to nearby lymph nodes but not to other organs; or cancer that has spread to other parts of the body but where that spread could be eliminated through local treatment
• People whose scans suggest surgery to fully remove or reduce the tumour is possible
• People with no suspected spread of cancer to the brain
• People who have at least one tumour that can be measured on scans according to standard criteria (RECISTv1.1)
• People with a good general level of physical functioning, rated 0 or 1 on a standard scale used by oncology teams (ECOG scale), meaning fully active or restricted in strenuous activity only
• People whose blood and liver function results meet the required levels: sufficient white blood cells, platelets, and haemoglobin (which may be supported by transfusion), and liver enzyme and bilirubin levels within the accepted range
• Women who are able to become pregnant must use an approved form of contraception during treatment and for 3 months after, must not be breastfeeding, and must have a negative pregnancy test within 7 days before joining
• Men who are able to father children must agree to use an approved form of contraception with their partner during treatment and for 3 months after
• People who volunteer to join, sign the consent form, and are willing to attend follow-up appointments

Who may not be able to join:

• People who have previously received radiotherapy, chemotherapy, long-term or high-dose steroid treatment, surgery, or targeted drug therapy for their cancer
• People who have had, or currently have, another cancer (unless it is well controlled and not expected to affect survival within 2 years)
• People who have previously been treated with PD-1 or PD-L1 immunotherapy drugs, or who have a known allergy to this type of medication or any of its ingredients
• People with an active autoimmune disease, or a history of one (such as autoimmune liver disease, lung inflammation, eye inflammation, bowel inflammation, thyroid conditions, kidney inflammation, or blood vessel inflammation) — though people with vitiligo or childhood asthma that fully resolved without adult treatment may still be considered (confirm with trial site)
• People who are currently taking, or have taken within the past 2 weeks, medications that suppress the immune system
• People with significant heart problems that are not well controlled, including moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past year, or serious heart rhythm problems requiring treatment
• People with abnormal blood clotting results, a tendency to bleed, or who are currently taking blood-thinning or clot-dissolving medications
• People who have had active bleeding in the stomach or digestive tract within the past 3 months due to conditions such as stomach ulcers, bowel inflammation, or certain vein abnormalities, or where the treating doctor considers there to be a risk of bleeding or bowel perforation
• People who have had a significant bleeding episode (30 mL or more within 3 months), coughed up blood (5 mL or more of fresh blood within 4 weeks), or experienced a blood clot, stroke, or mini-stroke within the past 12 months
• People who have an active infection or an unexplained temperature above 38.5°C at the time of screening or before the first dose
• People who have had an abdominal fistula (an abnormal internal tunnel), a hole in the bowel, or an abdominal abscess within the 4 weeks before the first dose
• People with evidence of lung scarring, chronic lung inflammation, or significant lung damage from any cause
• People with HIV, or active hepatitis B or C infection at levels above the specified thresholds — people who carry hepatitis B at lower levels may be eligible if they receive antiviral treatment at the same time (confirm with trial site)
• People currently taking part in another clinical trial, or who completed one within the past month, or who would need to receive other cancer treatments during this study
• People who have received a live vaccine within 4 weeks before starting the study drug, or who would need one during the study
• People with a known history of psychiatric drug misuse, heavy alcohol use, or substance abuse
• People who are unable or unwilling to cover any out-of-pocket costs for tests and treatments required by the study
• People who the treating doctor considers unsuitable for any other reason, including serious additional illnesses, significantly abnormal test results, or personal or social circumstances that could affect safety or the reliability of study data

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