Phase 2 Bladder 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 through a tissue sample (biopsy) with a specific type of bladder cancer that includes small cell or high-grade neuroendocrine features, with the cancer confined to the bladder and nearby lymph nodes (not spread to distant parts of the body).
• People who are able to provide a stored or freshly collected tissue sample from their tumour before the study begins; if fewer than 15 tissue slides are available, enrolment may still be possible after confirmation from the lead researcher.
• People who are considered medically well enough by their doctor to receive chemotherapy, immunotherapy, and bladder removal surgery.
• People who are 18 years of age or older at the time of signing the consent form.
• People with a good general health and activity level, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
• People whose recent blood test results (taken within 14 days before joining the study) show the blood, liver, and kidney are functioning within acceptable levels as defined by the trial.
• People who test negative for HIV at screening, or who have HIV but are stable on treatment, have an adequate immune cell count, and have an undetectable virus level in the blood.
• People who test negative for active Hepatitis B infection at screening, based on specific blood tests outlined by the trial.
• People whose kidney function meets the minimum level required; people receiving cisplatin (a specific chemotherapy drug) must meet a higher kidney function threshold.
• Women who could become pregnant must agree to use highly effective contraception or remain abstinent during treatment and for a set period after the last dose of each study drug, and must agree not to donate eggs during that time.
• Men who could father a child must agree to use highly effective contraception or remain abstinent, and must agree not to donate sperm, during treatment and for a set period after the last dose of each study drug.
• People who provide written informed consent in line with local guidelines.
• People who are currently taking low-dose steroids for conditions such as low blood pressure, adrenal insufficiency, asthma, or chronic lung disease (COPD).

Who may not be able to join:

• People who have already received systemic (whole-body) treatment for small cell bladder cancer.
• People who also have an active invasive cancer in the upper urinary tract (such as the ureter or the part of the kidney where urine collects), unless a non-invasive upper tract cancer was fully treated and follow-up testing showed no remaining disease.
• People who have another active cancer, other than certain low-risk skin cancers or prostate cancer that has only shown a rising blood marker (PSA) without other signs of disease; people who have finished treatment for another cancer and are considered to have less than a 30% chance of it returning are not excluded on this basis.
• People who have previously received systemic chemotherapy for bladder cancer; note that prior BCG therapy or chemotherapy given directly into the bladder is allowed.
• People whose cancer has spread to other parts of the body, including the brain or the lining around the brain and spinal cord.
• People with pain from the tumour that is not well controlled, or whose pain medication is not on a stable dose at the time of joining.
• People with high calcium levels in the blood that are uncontrolled or causing symptoms.
• People with an active or historical autoimmune disease or immune deficiency condition (such as lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, or similar conditions), with some exceptions: people with well-controlled hypothyroidism on thyroid hormone replacement, well-controlled Type 1 diabetes on insulin, or certain mild skin conditions affecting less than 10% of the body surface area that are well managed with low-potency creams may still be considered (confirm with trial site).
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, drug-related lung inflammation, or organising pneumonia, or people who show signs of active lung inflammation on a chest scan at screening.
• People with active tuberculosis.
• People who have had a significant heart or blood vessel event (such as a heart attack or stroke) within the 3 months before starting the study, or who have an unstable heart rhythm or unstable chest pain.
• People who have had major surgery, an open biopsy, or a serious injury within 4 weeks before starting the study drugs, or a minor procedure (such as a bladder biopsy) within 1 week before starting, or who have not yet recovered from such a procedure.
• People who have had another cancer (other than small cell bladder cancer) within the past 5 years, unless it was a very low-risk cancer such as certain early-stage skin cancers, cervical pre-cancer, early prostate cancer, or early uterine cancer.
• People who have had a serious infection requiring hospitalisation within 4 weeks before starting the study.
• People who have taken antibiotic tablets or infusions to treat an infection within 2 weeks before starting the study; people taking antibiotics to prevent infection (such as for urinary tract infections) may still be considered.
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor.
• People with any other significant medical condition, abnormal test result, or health issue that the trial team considers would make participation unsafe or interfere with the results.
• People who have received a live vaccine (such as the nasal flu vaccine) within 4 weeks before starting the study, or who may need one during treatment or within 5 months after the last dose of the immunotherapy drug (atezolizumab).
• People currently receiving antiviral treatment for Hepatitis B.
• People who have taken part in another clinical trial and received an experimental treatment within 28 days before starting this study.
• People who have previously received certain immunotherapy drugs, including checkpoint inhibitor antibodies (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments).
• People who have taken immune-stimulating drugs (such as interferon or IL-2) within 4 weeks or 5 half-lives of the drug (whichever is longer) before starting the study.
• People who have taken immune-suppressing medications (such as steroids, methotrexate, or similar drugs) within 2 weeks before starting the study, or who are expected to need them during the study; a single short course taken for a specific reason (such as a reaction to a scan dye) may be acceptable after confirmation from the lead researcher.
• People with a history of severe allergic reactions to certain types of antibody-based medicines.
• People with a known allergy to the specific components used to make atezolizumab (the immunotherapy drug used in this trial), including sensitivity to products derived from Chinese hamster ovary cells.
• People with a known allergy to cisplatin, carboplatin, or etoposide (the chemotherapy drugs used in this trial).
• People who are pregnant, breastfeeding, or planning to become pregnant during treatment or within 5 months after the last dose of atezolizumab; women who could become pregnant must have a negative pregnancy blood test within 14 days before starting the study.
• People who have previously had radiotherapy to the bladder, or who have had any radiotherapy within 4 weeks before starting the study, or who have not yet recovered from side effects of radiotherapy.

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