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 confirmed by tissue testing to have one of the following cancer types that cannot be surgically removed or has spread: high-grade neuroendocrine carcinoma (including small cell or large cell types) of the bladder or urinary tract; squamous cell carcinoma of the bladder or urinary tract; adenocarcinoma of the bladder or urinary tract; renal medullary carcinoma; or squamous cell carcinoma of the penis.
• People who are able to provide enough stored tissue samples (around 25 slides) from a previous biopsy, or who are willing to have a new biopsy if existing samples are not sufficient.
• People whose cancer has spread or cannot be removed, and — if previously treated — whose cancer has shown signs of getting worse on imaging scans.
• People in Cohort A who have already received a type of cancer treatment called immune checkpoint inhibitors (PD-1 or PD-L1 therapy), or who are not suitable to receive them.
• People in Cohort B who have not yet received immune checkpoint inhibitor treatment but who would be eligible to receive it.
• People whose cancer can be measured on scans according to standard medical criteria (RECIST 1.1).
• People aged 18 years or older.
• People who are generally well enough to carry out daily activities with minimal limitation (confirm with trial site for the specific performance scale used).
• People whose blood, liver, and kidney function results meet the required levels, as assessed by standard blood tests (confirm with trial site for specific values).
• People who have had any number of previous cancer treatments, or none at all — except those with high-grade neuroendocrine carcinoma of the bladder or urinary tract, who must have previously received a platinum-based chemotherapy combination.
• People who have brain or central nervous system (CNS) tumours that have already been treated, provided certain conditions are met: measurable disease must be present outside the brain; there is no history of bleeding in the brain or spinal cord; enough time has passed since brain surgery or radiation; no ongoing steroid medication is needed for brain disease; and any anti-seizure medication is at a stable dose.
• People who have had previous treatments must have waited a certain period before starting this trial — for example, at least 6 weeks after radionuclide treatment, 2 weeks after chemotherapy or radiotherapy, 2 weeks or five half-lives after targeted therapy, and at least 4 weeks or 5 half-lives after immune-stimulating treatments.
• People who have had major surgery (not for diagnosis) at least 4 weeks before starting the trial.
• People who have previously taken immune-suppressing medications must have stopped at least 2 weeks before starting the trial, with some exceptions for short-term or low-dose use (confirm with trial site).
• People taking hormone therapy for another cancer (such as breast or prostate cancer) may continue it, provided the treating doctor determines it is safe and does not interact with the study medications.
• People living with HIV may be eligible if they are on a stable HIV treatment regimen, have an adequate immune cell count, and have an undetectable viral load.
• People with hepatitis B may be eligible if they are being treated with appropriate antiviral medication and will be monitored during the trial.
• People with a history of hepatitis C may be eligible if they have been treated and cured, or if they are currently being treated and have an undetectable viral load.
• People who are able to become pregnant must agree to use at least one highly effective form of contraception during the trial and for up to 6 months after the last dose of study treatment, and must not donate eggs during this time.
• People who are able to father children must agree to use an effective form of contraception during the trial and for up to 6 months after the last dose, and must not donate sperm during this time.
• People who are currently breastfeeding must stop breastfeeding and must not resume until at least 1 month after the last dose of study treatment.
• People who are willing and able to understand the trial information and sign a consent form.

Who may not be able to join:

• People who have had a severe allergic reaction to medications similar to those used in this trial (sacituzumab govitecan, SN-38, irinotecan, atezolizumab, or products derived from Chinese hamster ovary cells).
• People who have brain or CNS tumours that are causing symptoms or have not yet been treated.
• People who have a positive pregnancy test at the time of screening.
• People who are unwilling to receive blood products if medically needed.
• People in Cohort B who have an active autoimmune disease, or a history of autoimmune disease that could come back and affect organ function or require immune-suppressing treatment — such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease, among others. Some exceptions apply, such as well-controlled thyroid conditions, Type 1 diabetes on insulin, or mild skin conditions meeting specific criteria (confirm with trial site).
• People with a history of certain lung conditions including pulmonary fibrosis, drug-related lung inflammation, or organising pneumonia, or who show signs of active lung inflammation on a CT scan at screening.
• People who are expected to need major surgery during the trial.
• People who have previously had a stem cell transplant or solid organ transplant from another person.
• People who have received a live vaccine within 4 weeks before starting the trial, or who expect to need one during treatment or within 5 months after the last dose (standard flu shots without live virus and approved COVID-19 vaccines are permitted).
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires draining more than once a month, unless a permanent drainage tube is already in place.
• People with uncontrolled or symptomatic high calcium levels in the blood.
• People who have had a significant heart problem — such as a heart attack, stroke, unstable heart rhythm, or unstable chest pain — within the 3 months before starting the trial.
• People in Cohort B (Arm 2) who have previously received immune checkpoint inhibitor therapy (such as anti-PD-1 or anti-PD-L1 treatments).
• People who have had another cancer within the past 2 years, with some exceptions for certain easily treated cancers such as skin cancers, early-stage cervical or breast changes, superficial bladder cancer, or low-risk prostate cancer (confirm with trial site).
• People with a history of cancer spreading to the lining of the brain and spinal cord (leptomeningeal disease).
• People with active tuberculosis.
• People with serious ongoing illness that is not well controlled and would make it difficult to participate in the trial.

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