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:

• People who have been diagnosed with kidney cancer (renal cell carcinoma, or RCC) confirmed by laboratory testing — all types are eligible except pure oncocytoma, collecting duct, medullary, and transitional cell cancer
• People who have no visible remaining cancer on a CT scan taken after surgery to remove the kidney cancer
• People whose cancer risk score (called a Leibovich score) falls between 3 and 11, as assessed by their medical team (confirm with trial site regarding intermediate-risk scoring cutoffs, as recruitment rules may have changed)
• People who had their kidney surgery at least 28 days but no more than 91 days before joining the trial
• People who have had a post-surgery CT scan within the 28 days before joining the trial
• People who had surgery to remove the whole kidney and where some cancer cells were found at the very edge of what was removed, as long as no visible remaining disease shows on the post-surgery CT scan
• People who are able to carry out daily activities with no or minimal limitations (WHO Performance Status 0 or 1)
• People who have stored tumour tissue from their surgery available, and who agree to provide at least one tissue sample and a blood sample for research purposes
• People whose blood test results show the body's organs are working well enough, including adequate levels of red blood cells, white blood cells, platelets, and liver and kidney function (specific values confirmed by the trial team)
• People whose heart tracing (ECG) shows a specific electrical measurement (QTcF) below 450 milliseconds
• People aged 18 years or older
• People who have given written consent to take part
• People who agree to follow the trial's rules about contraception during treatment and for 6 months afterwards, and to avoid donating eggs or sperm or breastfeeding during this time
• Women who are confirmed to be post-menopausal, or women who are pre-menopausal with a negative pregnancy blood test before joining (specific criteria for confirming menopause status are assessed by the trial team)

Who may not be able to join:

• People who have been previously diagnosed with kidney cancer (RCC) at any point before this trial
• People whose cancer has spread to other parts of the body, or where visible cancer remains after surgery
• People who had a partial kidney removal (partial nephrectomy) and where cancer cells were found at the edges of the removed tissue
• People who have a single lung nodule (a small spot on the lung) of 5mm or larger, unless it has been firmly identified as non-cancerous; people with multiple small lung spots under 5mm may still be considered if those spots have been stable for at least 8 weeks
• People who have received any cancer treatment other than kidney surgery for their RCC
• People who still have significant side effects (grade 2 or higher) from a previous cancer treatment, with some exceptions such as hair loss or skin pigment changes
• People who have had another type of cancer in the past, unless it was treated with the aim of cure, has shown no signs of returning for at least 5 years, and carries a low risk of coming back — or unless it was a treated skin cancer or pre-cancerous change with no current signs of disease
• People with a history of cancer that has spread to the membranes surrounding the brain and spinal cord
• People currently enrolled in another interventional clinical trial (participation in a non-interventional observational study is generally acceptable)
• People who have had a major surgical procedure within 28 days before starting treatment
• People who have used immune-suppressing medications within 14 days before starting the trial drugs, with some exceptions for low-dose or inhaled steroids
• People with active or previously documented autoimmune or inflammatory conditions (such as Crohn's disease, lupus, rheumatoid arthritis, and others), with some exceptions including stable thyroid conditions on hormone replacement, vitiligo, hair loss, certain skin conditions not needing systemic treatment, coeliac disease managed by diet alone, or conditions that have been inactive for at least 5 years (confirm with trial site)
• People with a history of immune deficiency conditions
• People who have received an organ transplant from another person
• People with uncontrolled ongoing illness, including active infection of any kind, uncontrolled high blood pressure, unstable heart conditions, active stomach ulcers, active bleeding disorders, or significant mental health or social situations that could affect safe participation
• People with active tuberculosis, active hepatitis B, active hepatitis C, or HIV (some exceptions apply for past resolved infections — confirm with trial site)
• People who have received a live vaccine within 30 days before starting treatment
• People who are pregnant or breastfeeding
• People with a known allergy or sensitivity to either of the trial drugs (durvalumab or tremelimumab) or their ingredients
• People with clinically significant lung inflammation or scarring
• People who, in the opinion of the investigator, have any condition that could affect how safely the trial can be carried out or how results can be understood

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