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:

• People who have been diagnosed with advanced kidney cancer (specifically the clear-cell type), confirmed by laboratory testing of a tissue or cell sample, who are being considered for continued treatment with nivolumab following an initial course of nivolumab plus ipilimumab as part of standard care.
• People who completed the initial nivolumab and ipilimumab treatment phase without serious side effects (grade 2 or higher), and whose cancer neither disappeared completely nor got significantly worse during that time.
• People aged 18 or older, of any sex.
• People who have a stored tumour tissue sample available for testing.
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST 1.1).
• People who are generally well enough to carry out light activity and care for themselves, as assessed by a standard medical scale (ECOG performance status 0 or 1).
• People whose blood tests, taken within 10 days before starting treatment, show that their bone marrow, liver, and kidneys are functioning adequately — including sufficient levels of white blood cells, platelets, and haemoglobin, and acceptable liver enzyme and kidney function readings (confirm specific values with the trial site).
• People who are able to understand and follow the study requirements, and who have signed a consent form agreeing to participate.
• People who are sexually active and able to have children must agree to use medically accepted contraception during the study and for 5 months after the last dose of study treatment (this applies to both participants and their partners).
• Women of childbearing potential must not be pregnant at the time of screening. This includes women who have had a period at any time in the past 12 months, as well as some women who have stopped having periods due to chemotherapy, certain medications, low body weight, or ovarian suppression (confirm with trial site).

Who may not be able to join:

• People who have previously received any other systemic (whole-body) treatment for advanced kidney cancer, apart from the initial nivolumab and ipilimumab course.
• People who have previously received treatment given before or after surgery intended to reduce the risk of cancer returning (adjuvant or neoadjuvant therapy).
• People who have active seizures, cancer that has spread to the brain or spinal cord, or cancer affecting the membranes surrounding the brain or spinal cord.
• People who have been diagnosed with another type of cancer within the past 2 years, unless it was a minor or early-stage cancer such as certain skin cancers, early breast or cervical cancer, or low-grade prostate cancer not requiring active treatment.
• People who have received radiation therapy to bone within the past 2 weeks, other external radiation within the past 4 weeks, or radiation delivered through the bloodstream within the past 6 weeks — or who are still experiencing significant problems from past radiation treatment.
• People with brain metastases that have not been successfully treated and stable for at least 3 months, or who still need steroid medication to manage brain-related symptoms.
• People currently taking blood thinners or anti-clotting medications at treatment doses (such as warfarin or clopidogrel).
• People who have experienced a heart attack, unstable chest pain, heart bypass surgery, stroke, or blood clot within the past 6 months.
• People currently taking regular steroid or other immune-suppressing medications, with some exceptions for low-dose or inhaled/topical steroids (confirm with trial site).
• People with serious ongoing heart conditions, including uncontrolled high blood pressure, dangerous heart rhythm problems, or serious heart failure.
• People with significant digestive system problems, such as active stomach ulcers, inflammatory bowel disease, bowel obstruction, or recent perforation or abscess in the abdomen (within 6 months).
• People who have had significant bleeding — such as coughing or vomiting blood — within the past 3 months.
• People with certain lung abnormalities, such as cavities in the lungs or tumours affecting major lung blood vessels.
• People with active infections requiring treatment, HIV/AIDS, or chronic hepatitis B or C infection.
• People with serious non-healing wounds, bone fractures, or problems absorbing nutrition from food.
• People with uncontrolled thyroid problems, moderate to severe liver disease, or who require dialysis.
• People who have previously had an organ transplant.
• People with a history of aneurysms or artery dissections.
• People who have had major surgery within the past 3 months, or who have not fully healed from surgery, or who are still experiencing complications from a past surgery.
• People whose heart's electrical activity (measured by an ECG test) shows a certain abnormality (QTcF above 500 msec) within the past month (confirm with trial site).
• People who have received a live vaccine within 4 weeks before starting nivolumab, or who plan to receive a live vaccine during the trial.
• People with an active autoimmune disease that could worsen with immune-stimulating treatment (some autoimmune conditions such as type 1 diabetes, vitiligo, or thyroid conditions not requiring immune-suppressing treatment may still be eligible — confirm with trial site).
• People currently using immune-suppressing medications, with limited exceptions for low-dose or topical steroids (confirm with trial site).
• People with a history of substance misuse, or personal, psychological, or social circumstances that could affect their ability to participate safely.
• People with unstable health conditions that could put their safety at risk during the study.
• Women who are pregnant or breastfeeding.
• People who are unable to swallow tablets or capsules.
• People with a known allergy or sensitivity to any component of the study treatments.
• People with rare inherited conditions affecting the body's ability to process certain sugars, including galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.

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