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 study's lead doctor)
• People who are 18 years of age or older at the time of signing the consent form
• People whose general physical functioning is rated at a level where they are able to care for themselves and are up and about for more than half of waking hours, or better (confirm with trial site — this refers to an ECOG score of 0, 1, or 2)
• People whose life expectancy is expected to be more than 3 months
• People who have been confirmed through laboratory testing to have kidney cancer (renal cell carcinoma) with a clear cell component, which may or may not also have a sarcomatoid component
• People whose kidney cancer is advanced (cannot be cured with surgery or radiation) or has spread to other parts of the body (stage IV), at any risk level
• People who have not previously received systemic (whole-body) treatment for kidney cancer — with one exception: one prior treatment given before or after surgery is allowed, as long as the cancer came back at least 6 months after the last dose and the person has fully recovered from any side effects
• People who have at least one area of cancer that can be measured on a scan
• People whose blood test results fall within the required ranges for white blood cells, platelets, red blood cells, liver function, kidney function, and blood clotting (confirm specific values with trial site)
• People living with HIV who are on effective treatment and whose virus has been undetectable within the past 6 months
• People with hepatitis B or C who have an undetectable viral load on testing
• People who meet the required infectious disease testing requirements, completed within 28 days before starting treatment
• Women who could become pregnant must have a negative pregnancy test within 72 hours of starting the study
• All participants who are sexually active and able to have children must agree to use accepted contraception methods during the study and for 5 months after the last dose of nivolumab or ipilimumab (or 30 days after the last dose of EXL01 for women)
• Women are considered able to become pregnant unless they have had a permanent sterilisation procedure or have been confirmed as postmenopausal (confirm specific criteria with trial site)

Who may not be able to join:

• People who have previously been treated with certain types of immunotherapy drugs that target checkpoint or T-cell pathways (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments)
• People who are currently using or intend to use probiotics, prebiotics, bacteria-containing foods, or similar natural supplements within 2 weeks before or during treatment
• People using herbal supplements or traditional plant-based medicines intended to treat the cancer or provide supportive care
• People who have had a faecal microbiota transplant (a gut bacteria procedure) within 3 months before screening
• People who require ongoing antibiotic treatment at the time of joining the study
• People with unstable heart conditions, including a heart attack in the past 6 months, severe heart failure, or uncontrolled irregular heartbeat or high blood pressure
• People with active or previously treated lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment
• People with a known medical condition that the study doctor believes would increase risk or affect the safety results (confirm with trial site)
• People who have received cancer treatment (chemotherapy, biological therapy, or other systemic treatments) within 4 weeks before the first study dose
• People who have had radiation therapy to bone within 2 weeks, other radiation therapy within 4 weeks, or radioactive substance treatment within 6 weeks before the first study dose
• People with brain metastases (cancer that has spread to the brain) unless these have been treated and stable for at least 4 weeks, and the person has no neurological symptoms and is not on steroid treatment
• People who have received a live vaccine within 30 days before the first study dose
• People who require regular steroid medication (above a low daily dose) or other immune-suppressing medications within 14 days before the first study dose (note: inhaled, nasal spray, joint injection, or skin-applied steroids are generally allowed)
• People with a history of certain lung scarring or inflammation conditions, or evidence of active lung inflammation on a chest scan
• People with active inflammatory bowel conditions (such as Crohn's disease, ulcerative colitis, or coeliac disease) or serious ongoing bowel disease with uncontrolled diarrhoea
• People with a known active tuberculosis infection based on clinical or imaging evidence
• People who have had major surgery within 4 weeks before the first study dose and have not fully recovered
• People with a condition that affects the body's ability to absorb nutrients (malabsorption syndrome)
• People with untreated or symptomatic underactive thyroid (hypothyroidism)
• People with moderate to severe liver impairment
• People who require kidney dialysis (haemodialysis or peritoneal dialysis)
• People who have had a solid organ transplant or a stem cell transplant from a donor
• People with active autoimmune diseases — with some exceptions including well-controlled type 1 diabetes, hypothyroidism managed only with hormone replacement, or certain skin conditions not requiring systemic treatment
• People who have difficulty swallowing oral medication, significant problems with eating, a bowel blockage, or who are unwilling or unable to receive intravenous (IV) medication
• People with a known or newly diagnosed parasitic gut infection within 3 months before screening
• People with a known allergy or serious reaction to any of the study medications or to similar types of drugs used in the past
• People with a known serious allergy to any component of EXL01 or similar live biotherapeutic products
• People with a soy allergy
• People who have another active cancer at the time of starting the study, or who were diagnosed with another cancer within the past 3 years that requires active treatment (some fully treated, low-risk skin cancers or very early-stage cancers may be exceptions — confirm with trial site)
• Women who are pregnant or breastfeeding
• People with any other condition that the study doctor believes makes participation unsafe
• People who, in the study doctor's opinion, may not be able to follow all study procedures

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