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:

• People who have given written consent to take part (or whose legal representative has done so on their behalf)
• People who agree to allow stored tumor tissue from a previous biopsy to be used for the study (exceptions may be possible with approval from the lead researcher)
• People who are reasonably active and able to care for themselves, with only limited physical restrictions due to illness (confirm with trial site what this means for individual circumstances)
• People aged 18 years or older
• People whose kidney cancer has been confirmed by laboratory testing to be a specific type called clear cell renal cell carcinoma, or a type with a sarcomatoid component
• People whose kidney cancer is advanced (cannot be cured by surgery or radiation) or has spread to other parts of the body, and is classified as intermediate- or poor-risk by a standard medical scoring system
• People who have not previously had systemic (whole-body) treatment for kidney cancer — with one exception: one prior course of treatment given before or after surgery is allowed, as long as the cancer came back at least 6 months after that treatment ended
• People whose cancer can be measured on scans according to standard medical criteria
• People who have recovered from most side effects of any previous cancer treatment (hair loss is an exception)
• People whose blood test results meet specific minimum levels for immune cells, platelets, and red blood cells (confirm exact values with trial site)
• People whose liver function blood test results are within acceptable ranges
• People whose kidney function meets a minimum level based on a standard calculation
• People whose blood clotting test results are within acceptable ranges
• Sexually active people who are able to have children and agree to use medically accepted contraception during the study and for a set period after the last treatment dose
• Women who are confirmed to not be pregnant at the time of screening, and who are either post-menopausal or have been permanently sterilised — or, if of childbearing potential, have a negative pregnancy test

Who may not be able to join:

• People who have previously been treated with the drugs ipilimumab and/or nivolumab
• People who are currently using, or plan to use, probiotics, yogurt, or foods fortified with bacteria during the treatment period
• People who have had allergic reactions to drugs with a similar make-up to the study drugs
• People who have active lung inflammation (a condition called interstitial lung disease or pneumonitis), or who have had this condition in the past and needed steroid treatment for it
• People with a known medical condition — such as ongoing diarrhoea or acute diverticulitis — that, in the doctor's opinion, would increase the risks of taking part or make it harder to assess safety
• People who have received any systemic cancer treatment (including experimental treatments) within 4 weeks before the first study dose
• People who have had radiation therapy to a bone within 2 weeks, or any other radiation therapy within 4 weeks, before the first study dose — or who received radioactive substance treatment within 6 weeks before the first study dose, or who have ongoing complications from prior radiation
• People with brain metastases or related disease that has not been adequately treated and stable for at least 4 weeks, or who still have neurological symptoms or need steroid treatment for brain metastases at the time of starting the study
• People who have received a live vaccine within 30 days before the first study dose
• People with serious ongoing or recent illnesses, including:
  • Anyone who has needed immune-suppressing medications or higher-dose steroids within 14 days before the first study dose (low-dose, inhaled, or topical steroids may be acceptable — confirm with trial site)
  • Anyone with an active infection needing treatment, active hepatitis B or C, HIV/AIDS requiring systemic treatment, or evidence of active tuberculosis
  • Anyone with a history of certain lung conditions, including pulmonary fibrosis or drug-induced lung inflammation, or evidence of active lung inflammation on a scan
  • Anyone with a condition that prevents proper absorption of food or medication
  • Anyone with uncontrolled or symptomatic underactive thyroid
  • Anyone with moderate to severe liver disease
  • Anyone who requires kidney dialysis
  • Anyone who has had a solid organ transplant or a stem cell transplant from a donor
  • Anyone with other significant health conditions that the doctor considers unsafe for participation
  • Anyone with an active autoimmune disease (certain exceptions apply, such as type 1 diabetes, thyroid conditions managed with hormone replacement only, or skin conditions not needing systemic treatment — confirm with trial site)
• Women who are pregnant or breastfeeding
• People who are unable to swallow tablets or capsules, or who cannot receive treatment through an intravenous (IV) drip
• People who have a known allergy or severe reaction to any ingredient in the study treatment, or who have had severe reactions to similar antibody-based drugs — or who have certain rare inherited conditions affecting how they process certain sugars
• People who have another active cancer at the time of joining, or who were diagnosed with another cancer within the past 3 years that still requires treatment (some early-stage or fully treated skin cancers and similar conditions may be exceptions — confirm with trial site)
• People with a history of heart muscle inflammation, significant heart failure, unstable chest pain, serious uncontrolled heart rhythm problems, uncontrolled infection, or a heart attack within the 6 months before joining
• People whose blood oxygen level on room air is below 92%
• People who, in the doctor's judgement, cannot safely take part in the study for any other reason
• People who, in the doctor's opinion, may not be able to follow all study procedures or requirements

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