Early Phase 1 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 joining the study
• People who are able to understand and follow the study requirements, and who have signed a consent form agreeing to take part
• People who are relatively well and able to carry out daily activities, as measured by standard medical performance scales (ECOG score of 0 or 1, or a Karnofsky score of at least 80%)
• People with a life expectancy of at least 12 weeks
• People with a confirmed diagnosis of advanced or metastatic kidney cancer (clear cell type, stage IV) that cannot be cured with surgery or radiation, where the more aggressive "sarcomatoid" cell type makes up less than half of the tumour
• People whose kidney cancer was originally localised but later spread after surgery to remove the kidney, whether or not they received additional treatment after that surgery
• People whose kidney cancer falls into any risk category (favourable, intermediate, or poor) based on standard medical scoring systems used for kidney cancer
• People who have at least one tumour that can be measured on a scan, meeting specific size requirements
• People whose blood test results show that the heart, liver, kidneys, bone marrow, and blood clotting system are all functioning adequately (blood tests must be done within 14 days before the first dose)
• People who can provide a stored or recently collected tumour tissue sample for central laboratory testing
• People who have recovered from side effects of any previous cancer treatments, back to their normal baseline or to a mild level, before starting the study
• People who are sexually active and able to have children, and who agree to use medically accepted contraception during the study and for 4 months after the last dose
• Women who could become pregnant must have a negative pregnancy test within 2 weeks before starting treatment; women are considered unable to become pregnant if they have had a hysterectomy, both fallopian tubes removed, both ovaries removed, or have confirmed menopause (confirmed with specific hormone and medical criteria)

Who may not be able to join:

• People who have previously received cabozantinib, nivolumab, ipilimumab, or any other systemic treatment specifically for advanced kidney cancer (prior treatment given after surgery in the adjuvant setting is acceptable)
• People who received any anti-cancer therapy within 4 weeks, or within five half-lives of that therapy, before the first study dose — whichever period is shorter
• People who received any small molecule targeted treatment (including experimental ones) within 2 weeks before the first study dose
• People who received radiation to bone within 2 weeks, radiation to any other area within 4 weeks, or radioactive substance treatments within 6 weeks before the first study dose; or people still experiencing significant complications from prior radiation
• People with cancer that has spread to the brain or the lining around the brain, unless it has been treated and has been stable for at least 4 weeks before the first dose
• People taking certain blood-thinning medications, including warfarin, dabigatran, betrixaban, or clopidogrel (some other blood thinners may be permitted — the trial site can confirm)
• People with serious ongoing or recent health conditions, including: severe heart failure, unstable chest pain, serious heart rhythm problems, uncontrolled high blood pressure, or a stroke, heart attack, or blood clot (such as a DVT or pulmonary embolism) within the past 6 months (some minor, stable, and treated clotting events may be considered — confirm with the trial site)
• People with certain digestive system problems, including tumour growing into the digestive tract, active stomach ulcers, Crohn's disease, diverticulitis, gallbladder inflammation, pancreatitis, or a blockage in the digestive system; or people who have had a hole in the bowel, bowel obstruction, or an internal abdominal abscess within the past 6 months
• People who have had significant bleeding — such as coughing or vomiting more than half a teaspoon of blood, or other serious bleeding — within the past 12 weeks
• People with certain types of lung lesions or airway involvement related to cancer
• People with tumours growing into or wrapping around major blood vessels
• People with other significant health conditions that could make study participation unsafe, including serious non-healing wounds or fractures, unmanaged underactive thyroid, or moderate-to-severe liver disease
• People who have had major surgery within 2 weeks, or minor surgery within 10 days, before the first dose; or people whose surgical wounds have not fully healed
• People whose heart electrical activity test (ECG) shows a specific measurement called QTcF above 500 ms within 14 days before the first dose
• People who have used immune-suppressing medications within 21 days before the first dose (some low-dose inhaled or nasal steroids may be allowed — confirm with the trial site)
• People who are pregnant or breastfeeding
• People who are unable to swallow tablets
• People with a known severe allergy or serious reaction to any of the study drugs (cabozantinib, nivolumab, ipilimumab, lenvatinib, or everolimus) or to similar types of medications
• People with another active cancer at the time of joining, or who have been diagnosed with another cancer within the past 3 years that requires active treatment (some fully treated localised skin cancers or early-stage cancers may be excepted — confirm with the trial site)
• People with a history of cancer spreading to the membranes lining the brain and spinal cord (leptomeningeal carcinomatosis)
• People who have received immune-stimulating treatments (such as IL-2) within 4 weeks or five half-lives before joining, whichever is shorter
• People who have received a live vaccine within 30 days before joining or within 30 days of starting study treatment, or who expect to need one during the study
• People who previously experienced a severe (Grade 3 or higher) immune-related side effect from an immunotherapy treatment, or who still have unresolved immune-related side effects above a mild level
• People with an active or recent (within the past 2 years) autoimmune disease, such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or similar conditions (some milder autoimmune conditions, such as vitiligo or well-controlled thyroid disease on stable medication, may not be excluded — confirm with the trial site)
• People with active or prior inflammatory bowel disease, or significant digestive system conditions that may affect how the study drug is absorbed
• People with a history of a primary immune deficiency disorder
• People who have previously received a bone marrow or organ transplant from another person
• People who have taken part in another clinical trial involving an experimental treatment within 28 days before joining this study
• People who, in the opinion of the treating doctor, have any condition that could affect how well the study drug works or make it difficult to assess safety

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