Phase 2 Kidney Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Initial eligibility (pre-screening):

• People aged 18 or older at the time of signing the consent form
• People diagnosed with kidney cancer (renal cell carcinoma) that has spread to other parts of the body or cannot be removed by surgery or treated with radiation
• People whose kidney cancer is classified as "favorable" or "intermediate" risk based on a standard medical scoring system called IMDC criteria
• People who are generally well enough to carry out daily activities, as measured by standard medical performance scales (confirm with trial site)
• People whose blood counts, liver function, and kidney function meet specific healthy thresholds as measured by blood tests
• People who are able to understand and follow the study requirements and have signed a consent form
• People who agree to use reliable contraception during the study and for 5 months after the last treatment, if they are sexually active and capable of having children
• Women who are capable of becoming pregnant must have a negative pregnancy test at the screening stage

Main eligibility (later in the process):

• People who have already received at least 12 months of a specific first-line combination treatment for their kidney cancer (a type of immunotherapy combined with a targeted therapy), and who have not had to stop due to side effects
• People whose scans (PET/CT) show the cancer has responded — either fully or partially — to that combination treatment within 24 months of starting it
• People who continue to meet the same risk, performance, blood test, consent, and contraception requirements listed above

Who may not be able to join:

At initial screening:

• People whose kidney cancer is a particularly aggressive type (high-grade pathology)
• People who have already received systemic treatment for advanced kidney cancer
• People whose kidney cancer is classified as "poor" risk under IMDC criteria
• People whose general health and ability to carry out daily activities falls below the required levels on standard medical performance scales
• People whose blood, liver, or kidney test results do not meet the required thresholds
• People with large tumours causing symptoms, or cancer that has spread to the liver
• People with active cancer spread to the brain or the lining of the brain, unless it has been treated and has been stable for at least 3 months
• People who have or have had another type of invasive cancer that could affect how the trial results are interpreted, with some exceptions for certain skin cancers or other cancers fully treated more than 3 years ago
• People with blood pressure that remains above 150/100 mmHg even with treatment
• People with serious uncontrolled health conditions in the past 6 months, including heart or blood vessel problems, certain bowel conditions, significant bleeding, severe infections, severe autoimmune diseases, or active HIV, hepatitis B, or hepatitis C
• People who have had major surgery in the past 4 weeks with wounds that have not healed, or who are expected to need major surgery during the study
• People taking medications that could interfere with how the study drugs work in the body
• People with known allergies to any component of the study drugs
• People receiving ongoing immune-suppressing medications, with the exception of inhaled or skin-applied steroids
• People with medical, psychological, or social conditions that would make it difficult to follow the study requirements
• People who are pregnant, breastfeeding, or who refuse to use contraception during and for 5 months after treatment
• People who are unable to have PET/CT scans or are unable to take oral (swallowed) medication

At main screening:

• People who were not able to complete at least 12 months of the required first-line combination treatment, for any reason including side effects
• People whose PET/CT scan does not show a response to treatment, or whose cancer has spread further or progressed
• People who do not meet the same risk level, performance, blood test, blood pressure, health condition, pregnancy, contraception, or scanning requirements listed above

Reasons a person may be withdrawn from the trial after joining:

• The cancer stops responding to treatment or gets worse
• Serious side effects occur during treatment
• Blood test results raise significant safety concerns
• The person chooses to withdraw their consent
• The treating doctor decides it is no longer in the person's best interest to continue
• Pregnancy occurs during the trial
• It is found that a person did not meet the eligibility criteria at the time of enrolment
• The person is unable or unwilling to follow the study requirements
• The person is lost to follow-up or passes away during the trial

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