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:

• People who have advanced kidney cancer (either spread to nearby areas that cannot be surgically removed, or spread to other parts of the body) of any type, whose cancer got worse during or after treatment with a drug called cabozantinib, and who responded to cabozantinib for at least 6 months
• People whose bodies were able to tolerate cabozantinib at the standard dose of 60mg daily, with side effects that were manageable, as judged by the treating doctor
• People who have previously received certain immunotherapy drugs (PD-1 or PD-L1 inhibitors) are still eligible
• People whose cancer can be measured on scans according to a standard set of medical guidelines (RECIST 1.1)
• For a small group of up to 5 people who agree to provide tissue samples: people who either have stored tumour tissue available from within the last 30 days and are willing to have a biopsy at 12 weeks, or are willing to have both a biopsy before starting the trial and another at 12 weeks
• People aged 18 or older at the time of signing the consent form
• People who are well enough to carry out some self-care but may not be able to do all normal activities — based on a standard health scale (ECOG score of 0, 1, or 2)
• People who are able to understand and follow the trial requirements and have signed the consent form
• People whose side effects from previous cancer treatments have either fully resolved or are only mild (Grade 1 or lower), unless those side effects are minor and being well managed
• People whose blood, liver, and kidney test results meet the required levels within 14 days before starting the trial, including:
  • A sufficient level of a type of white blood cell that fights infection (neutrophils ≥1500/µL), without the need for a special growth-stimulating medication
  • A sufficient overall white blood cell count (≥2500/µL)
  • A sufficient platelet count (≥100,000/µL), without recent transfusion
  • A sufficient haemoglobin level (≥9 g/dL), with transfusion permitted at the doctor's discretion
  • Liver enzyme levels (ALT, AST, and ALP) within acceptable ranges (a higher ALP level is allowed if bone spread has been confirmed)
  • A bilirubin level (a substance processed by the liver) within acceptable limits, with a slightly higher limit allowed for people with a specific liver condition called Gilbert's disease
  • A sufficient blood protein (albumin) level
  • Blood clotting test results within acceptable ranges
  • Kidney function test results within acceptable ranges
  • Urine protein levels within acceptable ranges
• People who are sexually active and able to have children (and their partners) must agree to use medically accepted contraception during the trial and for 4 months after the last dose; women who become pregnant or suspect pregnancy during the trial must inform their treating doctor immediately
• Women are considered able to become pregnant unless they have had documented permanent sterilisation (such as hysterectomy or removal of both ovaries or fallopian tubes), or documented menopause (no periods for 12 months in a woman over 45 without another medical cause); women under 55 must also have a specific hormone blood test result confirming menopause

Who may not be able to join:

• People who have received radiation therapy to bone within the last 2 weeks, any other radiation therapy within the last 4 weeks, or radiation treatment using radioactive substances given into the body within the last 6 weeks before starting the trial; people with ongoing significant complications from prior radiation are also not eligible
• People with cancer that has spread to the brain or the area around the spinal cord in the skull, unless it has been fully treated with surgery and/or radiotherapy, has been stable for at least 2 weeks after radiotherapy or 4 weeks after major surgery, the person has no neurological symptoms, and they are not taking steroid medications for the brain cancer at the time of starting the trial
• People taking certain blood-thinning medications, including warfarin, dabigatran, betrixaban, or clopidogrel; some other blood thinners may be allowed (confirm with trial site)
• People with serious uncontrolled ongoing health conditions, including:
  • Severe heart failure, unstable chest pain, or serious irregular heart rhythms
  • High blood pressure that remains uncontrolled despite treatment
  • A stroke, heart attack, or blood clot (such as a deep vein clot or clot in the lungs) within the past 6 months (some exceptions may apply for minor, stable clots — confirm with trial site)
  • Certain serious stomach or bowel problems, including tumour growing into the digestive tract, active stomach ulcers, inflammatory bowel disease, or related conditions; or a history of a hole in the bowel, bowel blockage, or abdominal abscess within the past 6 months
• People who have had significant bleeding (such as blood in urine requiring transfusion, or vomiting or coughing blood requiring hospitalisation) within the past 6 weeks
• People with hollow (cavitating) lung lesions that are causing symptoms, or with cancer growing inside the airways
• People whose cancer is growing into or wrapping around major blood vessels
• People with other significant health conditions that would make trial participation unsafe, including serious unhealed wounds, fractures or ulcers; moderate to severe liver disease; or an active COVID-19 infection (recovery of at least 14 days before joining is required)
• People who have had major surgery within 2 weeks, or minor surgery within 10 days, before starting the trial; people must also have fully healed from any surgery, and those with ongoing surgical complications are not eligible
• People with a specific heart rhythm measurement (QTcF interval) above 500 ms on a heart tracing (ECG) within 14 days before starting the trial, or a history of a condition that increases the risk of a dangerous heart rhythm abnormality (such as long QT syndrome)
• People who are pregnant or breastfeeding
• People who are unable to swallow tablets
• People with a known allergy or serious reaction to any of the ingredients in the study medications, a history of severe reactions to monoclonal antibody treatments, or certain rare inherited conditions affecting how the body processes certain sugars (galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)
• People who have had another type of cancer within the past 2 years that still requires active treatment — some early-stage or apparently cured cancers (such as certain skin cancers, early bladder cancer, low-grade prostate cancer, or early-stage cervical or breast cancer) may be exceptions (confirm with trial site)

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