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 been diagnosed with a specific type of kidney cancer called non-clear cell renal cell carcinoma (the subtypes papillary, chromophobe, oncocytic, unclassified, or "not otherwise specified") that has spread to other parts of the body, confirmed by a tissue or cell sample. Note: medullary carcinoma of the kidney and collecting duct tumors are not allowed.
• People whose cancer can be measured on a scan according to standard guidelines (called RECIST v1.1).
• People who have received no more than one previous systemic (whole-body) cancer treatment, which may have included immunotherapy or targeted therapy drugs. A waiting period after stopping the previous treatment is required before joining.
• People aged 18 or older.
• People who are well enough to carry out everyday activities, as measured by a standard performance scale (ECOG score of 2 or lower, or Karnofsky score of 60% or higher).
• People whose blood counts and organ function (including liver, kidneys, and bone marrow) meet the specific levels required by the trial.
• People with a history of hepatitis C who have been successfully treated and cured, or whose viral levels are undetectable if still on treatment.
• People with hepatitis B whose virus levels are undetectable while on suppressive treatment.
• People who have had cancer spread to the brain that has already been treated (at least 4 weeks prior), with no signs of the cancer growing in follow-up scans.
• People with new or growing brain metastases or spread to the lining of the brain, if the treating doctor determines that immediate brain-specific treatment is not needed right away and is unlikely to be needed during the first cycle of this trial.
• People who have had or currently have a separate, different cancer, as long as that cancer or its treatment is unlikely to affect the safety or results of this trial.
• People with a history of heart disease or prior treatment with heart-affecting drugs, provided a heart function assessment places them in Class 2B or better on the New York Heart Association scale.
• Women who could become pregnant and male participants who agree to use effective contraception before, during, and after the trial, as specified by the trial guidelines. Acceptable methods include hormonal contraception, intrauterine devices, surgical sterilisation, partner vasectomy, implantable or injectable contraceptives, and condoms with spermicide. Complete abstinence for the entire trial period is also accepted. Women who are post-menopausal or have had surgical procedures that prevent pregnancy may be exempt from this requirement (confirm with trial site).
• Male participants who agree to use adequate contraception from the start of the trial until 4 months after finishing the study treatment.
• People (or their legal representative) who have signed an approved written consent form before any trial-related procedures begin.

Who may not be able to join:

• People who have previously received the drug tivozanib.
• People who have previously received the drug nivolumab.
• People who have not fully recovered from side effects of a previous cancer treatment (side effects still at Grade 2 or higher), except for hair loss.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have had a serious allergic reaction to drugs chemically similar to tivozanib or nivolumab.
• People with poorly controlled high blood pressure (systolic above 150 mmHg or diastolic above 100 mmHg) while already on two or more blood pressure medications, confirmed on two separate measurements at least 2 hours apart, where blood pressure medications have not been increased in the 30 days before enrolment.
• People with a history of autoimmune disease, with some exceptions: vitiligo or hair loss conditions, stable thyroid conditions managed with hormone replacement, mild chronic skin conditions not requiring systemic treatment, or autoimmune conditions that have not required active treatment in the last 3 years (these cases may be considered after discussion with the lead investigator).
• People with active HIV infection, unless they are on effective anti-retroviral treatment with undetectable virus levels within the past 6 months.
• People with other medical conditions, mental health conditions, or abnormal test results that the local investigator believes could interfere with treatment, affect the person's ability to participate, or put the person at high risk of serious complications.
• People currently taking corticosteroids (such as prednisone) at a dose higher than 10 mg per day or the equivalent.
• People who are pregnant or breastfeeding, as the study drugs may harm an unborn baby or infant.
• People currently taking certain medications known as CYP3A inducers, which can interfere with how the study drugs work (confirm specific medications with trial site).

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