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:

• Adults aged 18 or older
• People who have been diagnosed with a specific type of kidney cancer called clear cell renal cell carcinoma (ccRCC), confirmed through a tissue sample taken with a needle. People who have not yet had a biopsy may be considered for screening if kidney cancer is suspected, but confirmation of ccRCC on a pre-treatment biopsy is required before joining the trial
• People whose kidney cancer meets certain staging criteria — specifically, a tumour classified as stage cT2 with high-grade or aggressive features, or stage cT3 or higher, or cancer that has spread to nearby lymph nodes — and for whom surgery to remove part or all of the kidney is planned (confirm with trial site)
• People who have a primary kidney tumour large enough to be measured on a scan (at least 10 mm / 1 cm in one direction)
• People who are planned to have surgery to remove their primary kidney tumour
• People with a good general health status, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
• People whose blood test results, taken within 14 days before starting treatment, show that their bone marrow, liver, and kidneys are functioning within the levels required by the trial (confirm specific values with trial site)
• People whose blood oxygen level stays above 88% during a 6-minute walking test
• People who do not have active lung inflammation (pneumonitis) at the time of screening
• People who do not have a history of severe chronic obstructive pulmonary disease (COPD)
• People whose heart pumping function (left ventricular ejection fraction) is within a normal range, as shown by a heart scan
• Women who could become pregnant must have a negative pregnancy blood test at screening
• People who are sexually active and able to have children must agree to use highly effective contraception throughout the trial and for a set period after the last dose of treatment (7 days after the last dose of one study drug, and 120 days after the last dose of the other). Men must also agree not to donate sperm, and women must agree not to donate eggs, during these periods
• People who are able to understand and sign a written consent form
• People who are able to swallow tablets

Who may not be able to join:

• People who have previously received any systemic (whole-body) treatment for kidney cancer
• People who have had radiation therapy within 4 weeks before starting the trial
• People who have clear evidence that their cancer has spread to distant parts of the body (metastases). Enlarged lymph nodes planned to be removed during surgery are allowed
• People who have lung inflammation or suspected inflammatory lung disease at screening
• People who have used complementary medicines (such as herbal supplements or traditional Chinese medicines) intended to treat their cancer within 2 weeks before the first dose
• People who have had another active cancer in the past year, with some exceptions for certain slow-growing or highly treatable cancers (confirm with trial site)
• People whose heart's electrical activity shows a specific abnormality on an ECG (a QTcF interval of 480 milliseconds or more)
• People who have a condition that affects how their body absorbs medicines taken by mouth
• People who have had a major heart or blood vessel event within the past 6 months, such as a heart attack, stroke, blood clot in the lungs, or severe heart rhythm problems
• People with serious ongoing or recent health conditions, including certain heart problems, uncontrolled high blood pressure, a history of stroke or heart attack within the past 12 months, significant blood clots within the past 3 months, or any history of heart muscle inflammation (myocarditis)
• People with serious digestive system conditions, including active peptic ulcers, inflammatory bowel disease, bowel obstruction, abdominal fistula, or known varicose veins in the stomach or oesophagus, among others (confirm full list with trial site)
• People with an autoimmune disease that has been active or required high-dose steroid treatment within the past two years (diabetes and thyroid autoimmune conditions are not excluded)
• People who require ongoing treatment with corticosteroids at doses above 10 mg of prednisone per day, or other medicines that suppress the immune system, within 14 days of joining the trial (some exceptions apply — confirm with trial site)
• People with an active infection that needs treatment with systemic antibiotics or other medicines
• People with active or chronic hepatitis B or C with a detectable viral load, or HIV with a detectable viral load, or AIDS-related illness
• People with serious wounds, ulcers, or bone fractures that are not healing
• People with poorly controlled underactive thyroid causing symptoms
• People with moderate to severe liver disease
• People who have had an organ transplant or a stem cell transplant from a donor
• People who have had major surgery within 4 weeks before starting the trial, or minor surgery within 7 days, or whose surgical wounds have not fully healed
• People currently taking strong medicines that affect a liver enzyme called CYP3A4, unless a washout period of 28 days or 5 half-lives of that medicine has passed before starting the trial drug (confirm with trial site)
• People with a history of psychiatric illness, mental health conditions, or substance use disorders that may affect participation or the ability to give informed consent
• People who have received a live vaccine within 28 days before the first dose
• People who are currently breastfeeding
• People with a known allergy or sensitivity to any component of the study medicines
• People who use supplemental or intermittent oxygen therapy
• People with any other condition that the trial investigator considers would make participation unsafe or impractical

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