Phase 3 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 are 18 years of age or older
• People who are able to understand and agree to sign a consent form, or who have a legal representative, caregiver, or family member who can do this on their behalf
• People who have been diagnosed with high-grade upper tract urothelial carcinoma (a type of cancer in the upper urinary tract) within the past 14 weeks, confirmed either by tissue sample (biopsy) with imaging or direct viewing of the tumor, or by a high-grade urine cell test combined with imaging or direct viewing of the tumor
• People whose cancer is of the standard urothelial carcinoma type, making up at least half of the cancer cells (other subtypes may be present, but must not be the main type)
• People whose recent blood test results show white blood cell, platelet, red blood cell, and liver function levels within the ranges required by the trial (confirmed with blood tests taken within 14 days before joining)
• People who are not pregnant or breastfeeding, and who have had a pregnancy test within 14 days before joining (if there is any possibility of pregnancy)
• People who agree to use effective contraception or abstain from sex from the time of joining, throughout treatment, and for at least 6 months after the last treatment dose
• People whose imaging (taken within 28 days before joining) shows no signs that the cancer has spread to other parts of the body or to nearby large lymph nodes
• People with a history of certain other cancers may still be eligible, including those with previously treated or monitored non-aggressive cancers, or prior urothelial cancers that were at an early stage or have shown no signs of disease for more than 2 years (confirm specific history with trial site)
• People who do not have any serious uncontrolled illnesses, such as active infections, uncontrolled heart problems, significant liver disease, certain lung conditions, or serious mental health conditions in the three months before joining
• People living with HIV who are on effective treatment with an undetectable viral load and meet specific immune cell count requirements (confirm details with trial site)
• People with a history of hepatitis B who are on suppressive treatment with an undetectable viral load
• People with a history of hepatitis C who have been treated and have an undetectable viral load
• People with heart-related history who are assessed as having reasonably good heart function (Class 2B or better on a standard heart function scale)
• People who weigh more than 30 kg
• People who are expected to live at least 12 weeks or more
• People whose kidneys are functioning above a minimum level, based on a blood test taken within 28 days before joining (confirm specific level with trial site)

Who may not be able to join:

• People whose cancer includes a small cell or neuroendocrine component
• People who are currently pregnant or breastfeeding
• People with signs that the cancer has spread to distant parts of the body, or with significantly enlarged nearby lymph nodes on imaging
• People with another active cancer diagnosis within the past two years, with some exceptions such as certain treated skin cancers, in situ cancers, or low-risk prostate cancer under monitoring (confirm specific history with trial site)
• People with a history of advanced or metastatic urothelial cancer (stage pT4b or higher, lymph node involvement, or distant spread)
• People who have previously received systemic immune checkpoint inhibitor therapy for urothelial cancer
• People who have an uncontrolled illness such as active tuberculosis, unstable heart conditions, significant liver cirrhosis, interstitial lung disease, or serious psychiatric conditions
• People who have previously had radiation to 25% or more of their bone marrow
• People who have previously received a type of chemotherapy called anthracycline therapy
• People with an active or recent autoimmune disease requiring immune-suppressing treatment within the past 2 years, or any history of inflammatory bowel disease, certain nerve or muscle autoimmune conditions, or immune-related lung inflammation (some autoimmune conditions such as well-controlled thyroid disease, vitiligo, mild skin conditions, or diet-controlled coeliac disease are exceptions — confirm with trial site)
• People who are currently taking or have recently taken immune-suppressing medications within 14 days before the first treatment dose, with some exceptions such as low-dose steroids, topical or inhaled steroids, or steroid pre-medications for allergic reactions
• People who have received a live vaccine within 30 days before the first treatment dose
• People who have had a major surgical procedure within 28 days before joining (note: minor procedures such as cystoscopy, stent placement, or similar are not considered major surgery)
• People who have had an organ transplant using a donor organ
• People whose kidney function falls below the minimum required level (confirm specific threshold with trial site)

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