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 aged 18 years or older, of any self-identified gender, who meet the other criteria listed.
• People who have been diagnosed with a type of kidney cancer called clear cell renal cell carcinoma (RCC), confirmed by a tissue biopsy or sample.
• People whose treating urologist has determined that surgery to remove the kidney (nephrectomy) is appropriate, whether to try to cure the cancer or to reduce its size.
• People whose cancer has been staged at cT3b, cT3c, or cT4 (meaning the tumour has grown into nearby structures such as large blood vessels).
• People whose cancer has spread to nearby lymph nodes (cN1) or has not spread to lymph nodes (cN0).
• People whose cancer has spread to distant parts of the body (cM1) or has not spread beyond the local area (cM0).
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard scale (ECOG performance status 0–2).
• People with low levels of protein in their urine, confirmed by testing (less than 2+ on a dipstick test, or less than 2g in a 24-hour urine collection if the dipstick shows 2+ or higher).
• People who are able to provide a negative pregnancy test within 14 days before starting the trial treatment, if there is any possibility of pregnancy.
• People who are able and willing to follow all study procedures for the full duration of the trial and to sign a consent form.

Who may not be able to join:

• People who have taken part in another clinical trial involving an experimental treatment or device within the past 4 weeks.
• People who have had major surgery within the past 4 weeks, or radiation therapy within the past week.
• People who have previously been treated with certain types of immunotherapy drugs that target the PD-1 or PD-L1 pathways, or similar immune-regulating treatments.
• People who have previously received certain targeted treatments for kidney cancer that affect blood vessel growth (VEGF or VEGFR therapies).
• People who have had a severe allergic reaction to one of the trial drugs (Axitinib), such as a serious rash, low blood pressure, swelling, or anaphylaxis.
• People who have an immune system disorder, or who have been taking immune-suppressing medications (including steroids above a low dose equivalent) within the past 7 days, except in certain cases involving cancer that has spread to the brain.
• People who have an active autoimmune disease requiring ongoing treatment within the past 2 years, or a history of a severe autoimmune condition. (Note: Some stable conditions such as Type 1 diabetes, vitiligo, or thyroid problems managed with hormone replacement may still be eligible — confirm with the trial site.)
• People who have had another cancer that has been active or required treatment within the past 3 years. (Note: Certain treated skin cancers, early-stage cancers, or localised prostate cancer may still be eligible — confirm with the trial site.)
• People who have active cancer that has spread to the brain or the lining around the brain.
• People who have had lung inflammation (pneumonitis) in the past that required steroid treatment, or who currently have pneumonitis.
• People whose liver enzyme levels (ALT or AST) are more than three times the normal upper limit.
• People who have received a live virus vaccine within the past 30 days.
• People who have had active bleeding in the digestive system (such as vomiting blood or blood in the stool) in the past 3 months without confirmed evidence of healing.
• People who have tumours in the digestive tract that may be at risk of bleeding, or conditions such as inflammatory bowel disease or ulcerative colitis that increase the risk of bowel perforation.
• People with an abnormal heart rhythm measurement (QTc interval of 480 milliseconds or more on an ECG).
• People who have had certain serious heart or blood vessel events within the past 12 months, including a heart attack, unstable chest pain, a stroke or mini-stroke, heart bypass surgery, coronary stenting, or severe heart failure (Class III or IV).
• People with poorly controlled high blood pressure, defined as readings of 150/90 mmHg or higher despite taking three or more blood pressure medications at optimised doses.
• People who have wounds that are not healing well, as assessed by their treating doctor.
• People with an active bleeding disorder or a significant bleeding episode within the past 30 days.
• People currently taking, or expected to need, certain medications or foods that strongly affect how the body processes the trial drugs (known as strong CYP3A4/5 inhibitors or inducers — confirm specific medications with the trial site). This includes some herbal supplements such as St. John's Wort, and certain epilepsy or antibiotic medications.
• People currently taking medications known to cause dangerous heart rhythm problems (confirm specific medications with the trial site).
• People with a psychiatric condition or substance use problem that would make it difficult to follow the trial requirements, based on their own report.
• People who have previously had a solid organ transplant (such as a kidney, liver, or heart transplant).
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and for 120 days after the last dose of trial medication.

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