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.

This trial has two separate groups (Cohort A and Cohort B) with different criteria. Please read both carefully and confirm with the trial site which group may apply.

Cohort A — Trial combining two drugs (Sacituzumab Govitecan + Enfortumab Vedotin)

Who might be able to join this trial:

• People who have been confirmed by tissue testing to have urothelial cancer (cancer of the bladder, kidney drainage system, ureter, or urethra), where urothelial cells make up more than half the cancer; locally advanced cancer that cannot be surgically removed is also included
• People whose bodies can tolerate cisplatin (a common chemotherapy drug) and who have already received platinum-based chemotherapy and an immune checkpoint inhibitor (a type of immunotherapy that helps the immune system fight cancer) for advanced or metastatic disease, under specific timing and treatment history conditions (confirm details with trial site)
• People whose bodies cannot tolerate cisplatin and who have already received at least one prior treatment for their cancer, either in the advanced/metastatic setting or in the pre/post-surgery setting within 12 months of the cancer coming back
• People whose cancer is continuing to grow or spread after their most recent treatment
• People aged 18 or older
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work)
• People whose blood counts, liver function, and kidney function meet the minimum levels required by the trial (confirmed by blood tests)
• People living with HIV who are on effective HIV treatment and have had an undetectable viral load within the past 6 months
• People with chronic hepatitis B who have an undetectable viral load while on appropriate treatment
• People who have had hepatitis C and have been successfully treated and cured, or who are currently being treated and have an undetectable viral load
• People with a known history of heart disease or previous treatment with heart-affecting drugs, provided a heart function assessment places them at class 2B or better on a standard heart health scale
• People who have measurable cancer visible on a CT or MRI scan, using standard measurement guidelines
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting the study drugs
• Women who could become pregnant must agree to use two forms of contraception, or be surgically sterile, or abstain from heterosexual activity, during the study and for 6 months after the last dose
• Men must agree to use adequate contraception during the study and for 4 months after finishing one of the study drugs, and for 6 months after the last study drug overall
• People who are able to understand the study and are willing to sign a consent form

Who may not be able to join:

• Women who are pregnant or breastfeeding
• People who have received a biologic cancer treatment (including immunotherapy) within the past 4 weeks, or chemotherapy, targeted therapy, or radiation therapy within the past 2 weeks before starting the trial
• People who still have significant side effects from previous cancer treatments that have not returned to mild or baseline levels
• People who have previously received a type of chemotherapy called a topoisomerase 1 inhibitor, or who have previously received either of the two study drugs
• People with an active second cancer (people with a cancer history that has been fully treated with no signs of active cancer for the past 3 years, or those with surgically removed low-risk tumours, may still be considered)
• People with active cancer spread to the brain or the lining of the brain and spinal cord; people with previously treated and stable brain metastases may be considered if certain conditions are met (confirm with trial site)
• People with certain active heart conditions, including: a heart attack or unstable chest pain within the past 6 months; a history of serious abnormal heart rhythms or conditions requiring certain medications; a history of a prolonged QT interval on a heart tracing; or moderate-to-severe heart failure or significantly reduced heart pumping function
• People with active chronic inflammatory bowel disease (such as ulcerative colitis or Crohn's disease) or a hole/tear in the digestive tract within the past 6 months
• People with a serious active infection currently requiring antibiotic treatment
• People with other medical or mental health conditions that the trial doctor believes could affect the study results or prevent the person from completing the trial
• People who require high doses of steroid medication (above 10 mg/day of prednisone or equivalent) or other immune-suppressing medications (inhaled or topical steroids are allowed if there is no active autoimmune disease)
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-induced lung inflammation, or active lung inflammation seen on a chest scan
• People currently taking part in another clinical trial involving an experimental treatment
• People with a known history of serious allergic reactions to drugs chemically similar to either of the study drugs, or to certain ingredients in the drug formulations
• People with other illnesses that are not well controlled
• People with mental health or personal circumstances that would make it difficult to follow the study requirements
• People with uncontrolled diabetes, defined by specific blood sugar markers (confirm definition with trial site)
• People with uncontrolled cancer-related bone pain or a risk of pressure on the spinal cord

Cohort B — Trial combining three drugs (Sacituzumab Govitecan + Enfortumab Vedotin + Pembrolizumab)

Who might be able to join this trial:

• People who have been confirmed by tissue testing to have urothelial cancer (cancer of the bladder, kidney drainage system, ureter, or urethra), where urothelial cells make up more than half the cancer; locally advanced cancer that cannot be surgically removed is also included
• People who have not yet received any treatment specifically for metastatic (widely spread) urothelial cancer; treatment given before or after surgery is allowed with no time restrictions, and prior immunotherapy is allowed if the last dose was more than 6 months ago
• People aged 18 or older
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work)
• People whose blood counts, liver function, and kidney function meet the minimum levels required by the trial (confirmed by blood tests)
• People living with HIV who are on effective HIV treatment and have had an undetectable viral load within the past 6 months
• People with chronic hepatitis B who have an undetectable viral load while on appropriate treatment
• People who have had hepatitis C and have been successfully treated and cured, or who are currently being treated and have an undetectable viral load
• People with a known history of heart disease or previous treatment with heart-affecting drugs, provided a heart function assessment places them at class 2B or better on a standard heart health scale
• People who have measurable cancer visible on a CT or MRI scan, using standard measurement guidelines
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting the study drugs
• Women who could become pregnant must agree to use two forms of contraception, or be surgically sterile, or abstain from heterosexual activity, during the study and for 6 months after the last dose
• Men must agree to use adequate contraception during the study and for 4 months after finishing one of the study drugs, and for 6 months after the last study drug overall
• People who are able to understand the study and are willing to sign a consent form

Who may not be able to join:

• Women who are pregnant or breastfeeding
• People who have received a biologic cancer treatment (including immunotherapy) or chemotherapy within the past 26 weeks (approximately 6 months) before starting the trial
• People who have previously received a type of chemotherapy called a topoisomerase 1 inhibitor, or who have previously received either of the two main study drugs
• People with an active second cancer (people with a cancer history that has been fully treated with no signs of active cancer for the past 3 years, or those with surgically removed low-risk tumours, may still be considered)
• People with active cancer spread to the brain or the lining of the brain and spinal cord; people with previously treated and stable brain metastases may be considered if certain conditions are met, including being on no more than 10 mg/day of prednisone or equivalent (confirm with trial site)
• People with certain active heart conditions, including: a heart attack or unstable chest pain within the past 6 months; a history of serious abnormal heart rhythms or conditions requiring certain medications; a history of a prolonged QT interval on a heart tracing; or moderate-to-severe heart failure or significantly reduced heart pumping function
• People with active chronic inflammatory bowel disease (such as ulcerative colitis or Crohn's disease) or a hole/tear in the digestive tract within the past 6 months
• People with a serious active infection currently requiring antibiotic treatment
• People with other medical or mental health conditions that the trial doctor believes could affect the study results or prevent the person from completing the trial
• People who require high doses of steroid medication (above 10 mg/day of prednisone or equivalent) or other immune-suppressing medications (inhaled or topical steroids are allowed if there is no active autoimmune disease)
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-induced lung inflammation, or active lung inflammation seen on a chest scan
• People currently taking part in another clinical trial involving an experimental treatment
• People with a known history of serious allergic reactions to drugs chemically similar to any of the three study drugs, or to certain ingredients in the drug formulations
• People with other illnesses that are not well controlled
• People with mental health or personal circumstances that would make it difficult to follow the study requirements
• People with uncontrolled diabetes, defined by specific blood sugar markers (confirm definition with trial site)
• People with uncontrolled cancer-related bone pain or a risk of pressure on the spinal cord
• People who have had an autoimmune disease (a condition where the immune system attacks the body) that required ongoing medical treatment in the past 2 years; however, certain conditions are specifically excluded from this rule, including vitiligo, psoriasis, type 1 diabetes, stable hypothyroidism, resolved childhood asthma or allergies, and conditions managed only with hormone replacement or inhaled/topical treatments (confirm specifics with trial site)

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