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 who have been diagnosed with metastatic kidney cancer (cancer that has spread beyond the kidney), confirmed by a tissue sample, with a tumour type that is either clear cell, papillary, chromophobe, or unclassified. Tumours with sarcomatoid features are also accepted.
• People whose cancer got worse during or within six months after receiving at least two rounds of a type of immunotherapy called a PD-1/PD-L1 checkpoint inhibitor, with that progression confirmed by scans.
• People who have received no more than two prior treatments for their cancer overall, with no more than one of those being a PD-1/PD-L1 immunotherapy — and that immunotherapy must have been the most recent treatment received.
• People who have at least one tumour that can be measured on a scan according to standard criteria (RECIST v1.1).
• People whose pre-treatment tumour biopsy sample contains at least 75% living tumour tissue.
• People who have finished palliative radiotherapy to non-brain areas at least 2 weeks before the first dose of study treatment (tumours in previously treated areas may still count if they have clearly grown and can be accurately measured).
• People whose side effects from previous cancer treatments have mostly resolved, returning to near-normal or only mild levels, except for stable, manageable conditions such as an underactive thyroid.
• People aged 18 or older who are reasonably active and able to care for themselves (ECOG performance status below 2), have an ASA score of 2 or less, and are expected to live at least 6 months.
• People whose liver function blood tests are within acceptable ranges — liver enzymes no more than 3 times the upper limit of normal (or up to 5 times if cancer has spread to the liver), and bilirubin no more than 1.5 times the upper limit of normal (a higher level is allowed for people with a condition called Gilbert's syndrome).
• People whose kidneys are functioning adequately, based on blood and urine test results meeting specific thresholds (confirm with trial site).
• People whose blood counts are within acceptable ranges, including white blood cells, neutrophils, platelets, lymphocytes, and haemoglobin, with no blood transfusion in the 14 days before testing.
• People who test negative for HIV, hepatitis B surface antigen (or have hepatitis B core antibody with undetectable hepatitis B virus), and hepatitis C antibody (or have hepatitis C antibody with undetectable hepatitis C virus).
• People who are willing and able to follow the study schedule and provide written consent to take part.

Who may not be able to join:

• People who have taken systemic antibiotics in the 4 weeks before screening, used live bacterial preparations or commercial prebiotics in the 2 weeks before screening, or plan to use probiotics, yogurt, or bacteria-supplemented foods during the treatment period.
• People who had to permanently stop immunotherapy in the past due to serious immune-related side effects.
• People who have an active or known autoimmune disease, except for type 1 diabetes, an underactive thyroid managed with hormone replacement only, or vitiligo.
• People who have a weakened immune system — including those with confirmed immune deficiency, those taking corticosteroid medicines at a dose higher than 10 mg of prednisone per day (not including inhaled or skin-applied steroids), or those who needed treatment for an autoimmune condition in the past 2 years.
• People who have previously received a type of immunotherapy called a CTLA-4 inhibitor, or who have had more than two prior systemic treatment regimens.
• People with a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), chronic severe diarrhoea, severe immune-related bowel inflammation, cancer that has spread to the digestive tract, or major abdominal surgery that may affect how the gut absorbs or moves food.
• People who have difficulty swallowing or are otherwise unable to take oral medication as required by the study.
• People whose cancer is growing so quickly that, in the treating doctor's opinion, they could not safely wait through the required washout and preparation periods before starting the trial treatment.
• People with active lung inflammation (interstitial lung disease or pneumonitis), or a history of either condition that required steroid treatment.
• People with known brain metastases or related brain conditions, unless those have been treated and remained stable for at least 4 weeks before the first dose of study treatment.
• People with a history of heart muscle inflammation, moderate-to-severe heart failure, unstable chest pain, uncontrolled serious heart rhythm problems, or a heart attack within the 6 months before enrolment.
• People who have recently received other cancer treatments — including targeted therapy pills within 2 weeks, chemotherapy or other systemic therapies within 4 weeks, or radiotherapy within 2 to 4 weeks depending on the area treated (confirm with trial site).
• People who need any other cancer treatment during the study, other than bone-protective medicines such as bisphosphonates or denosumab.
• People who have been diagnosed with another active cancer within the past 2 years, with the exception of certain slow-growing or early-stage cancers such as non-melanoma skin cancer or carcinoma in situ.
• People whose blood counts or organ function test results fall outside the acceptable ranges specified by the trial (confirm with trial site for exact values).
• People with uncontrolled cancer-related pain, fluid build-up around the lungs or heart or in the abdomen requiring drainage more than once a month, moderate-to-severe liver impairment, or uncontrolled high calcium levels in the blood.
• People who have previously had an organ transplant or stem cell transplant from a donor.
• People with active hepatitis B, active hepatitis C, or HIV infection.
• People who have had major surgery within 4 weeks before starting the study treatment.
• People with a known allergy to food or antibiotics.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study or within 120 days after the last dose.
• People who require dialysis, have a condition affecting how the gut absorbs nutrients, have uncontrolled electrolyte imbalances, or need specific blood-thinning medicines such as warfarin.
• People with any medical or psychological condition that, in the opinion of the trial team, could affect their safety or ability to follow the study requirements.

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