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 already received at least one systemic (whole-body) treatment for advanced, inoperable, or metastatic cancer — or whose treating doctor considers there are no standard treatments that would provide meaningful benefit, or who cannot tolerate or have declined standard treatments.
• People with an activity and self-care ability level rated 0 or 1 on a standard medical scale (ECOG) for the Phase 1B part of the trial, or rated 0, 1, or 2 for the Phase 2 part (confirm with trial site).
• People who have only one active cancer at the time of joining.
• Adults aged 18 years or older.
• People with a confirmed stage IV cancer that is considered "immunogenically cold" (a cancer type that tends not to respond well to immune-based treatments) or otherwise incurable, from one of these specific cancer types: bile duct or gallbladder cancer; metastatic breast cancer that is HR-negative and HER2-positive, with at least 3 prior treatment lines including specific targeted therapies (trastuzumab, pertuzumab/trastuzumab, and ado-trastuzumab emtansine); grade 2 or 3 well- or moderately-differentiated neuroendocrine cancer (certain other grades are not eligible); stage IV or metastatic high-grade ovarian, primary peritoneal, or fallopian tube cancer that no longer responds to platinum-based chemotherapy and has no acceptable standard treatment remaining; pancreatic adenocarcinoma; soft tissue sarcoma; castration-resistant prostate cancer (with very low testosterone levels) that has progressed on, or where the person has declined or cannot tolerate standard therapies, and has had at least one prior treatment with a specific hormone-blocking drug or chemotherapy; or vulvar cancer.
• People whose blood counts and organ function (such as liver and kidneys) meet the required health levels (confirm specific values with trial site).
• People who are on blood-thinning medication, provided the dose has been stable for at least 2 weeks before starting the trial.
• People who test negative for hepatitis B surface antigen at the screening stage.
• People who test negative for HIV at screening — or, if HIV-positive, people who are stable on anti-retroviral treatment, have an adequate immune cell count (CD4 ≥ 200/uL), and have an undetectable viral load.
• Women who could become pregnant must agree to use a highly effective form of contraception (with less than 1% failure rate per year) throughout the study and for at least 160 days after the last dose of study treatment.
• Men with female partners who could become pregnant must agree to use contraception approved by their doctor throughout the study and for 160 days after the last dose of study treatment.
• People whose cancer can be measured using standard imaging criteria (called RECIST).
• People with a life expectancy of at least 12 weeks.
• People who are willing and able to give written informed consent and follow all study-related procedures.
• People who have tumor tissue samples available (either stored tissue from within the last 3 years, or 12 unstained slides) for research testing.
• If a new biopsy is needed for diagnostic reasons, it must be taken from a tumor site that is not the only measurable site of disease.
• People who are able to swallow capsules.

Who may not be able to join:

• People whose tumors have a specific genetic feature called MSI-H or dMMR (a marker of certain DNA repair problems).
• People with severe uncontrolled high blood pressure (systolic above 150 mmHg or diastolic above 100 mmHg).
• People who have previously been treated with a specific type of anti-cancer drug called a VEGFR tyrosine kinase inhibitor.
• People who are unwilling or unable to use an effective contraception method for the entire study period and for at least 160 days after the last dose.
• People who are pregnant or breastfeeding.
• People with a history of cancer spreading to the membranes lining the brain and spinal cord (leptomeningeal disease).
• People with uncontrolled or symptomatic high calcium levels in the blood.
• People with cancer-related pain that is not well controlled.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires drainage more than once a month (an exception applies for ovarian cancer with abdominal fluid, and people with permanent drainage tubes in place may still be eligible).
• People with an active autoimmune disease or immune deficiency condition (such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and others) — though some exceptions may apply, including: people with autoimmune-related underactive thyroid who are stable on thyroid hormone replacement; people with well-controlled Type 1 diabetes on insulin; and people with certain skin-only conditions (such as eczema, psoriasis, or vitiligo) that cover less than 10% of the body, are well controlled with only mild topical steroids, and have not required stronger treatments in the past 12 months (confirm with trial site).
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-induced or idiopathic pneumonitis, or who show signs of active pneumonitis on a chest CT scan at screening.
• People with active tuberculosis.
• People with significant heart or blood vessel disease within the 3 months before starting the trial, including heart failure (Class II or above), recent heart attack, recent stroke, unstable abnormal heart rhythm, or unstable chest pain.
• People who have had a major surgical procedure (other than for diagnosis) within 4 weeks before starting the trial, or who are expected to need major surgery during the study.
• People with a history of a different cancer within the past 5 years, unless that cancer had a very low risk of spreading or causing death (such as certain early-stage or in-situ cancers) — confirm with trial site.
• People who have had a serious infection within 4 weeks before starting the trial (for example, one requiring hospitalisation, or a bloodstream infection or severe pneumonia), or any active infection that could affect safety.
• People who have been treated with antibiotic tablets or infusions for a therapeutic reason within 2 weeks before starting the trial (people taking preventive antibiotics may still be eligible — confirm with trial site).
• People who have previously received an allogeneic stem cell or solid organ transplant (a transplant using cells or an organ from another person).
• People currently receiving antiviral treatment for hepatitis B virus.
• People who have received another experimental treatment within 28 days before starting the trial.
• People who have previously been treated with certain immune checkpoint drugs (including anti-CTLA-4, anti-PD-1, or anti-PD-L1 antibodies) or CD137 agonists.
• People who have received immune-stimulating medications within 4 weeks (or 5 half-lives of the drug, whichever is longer) before starting the trial.
• People who have received immune-suppressing medications within 2 weeks before starting the trial, or who are expected to need them during the trial — though some exceptions apply, such as short-course low-dose steroids for a specific reaction, or steroids used for asthma, COPD, low blood pressure, or adrenal insufficiency (confirm with trial site).
• People with a history of severe allergic reactions (anaphylaxis) to certain types of laboratory-made antibody or protein therapies.
• People with a known allergy to the ingredients used to make the study drug atezolizumab, including proteins derived from Chinese hamster ovary cells.
• People with any other medical condition, abnormal test result, or finding that the treating doctor believes would make the trial treatment unsafe or affect the reliability of the results.
• People who have received a live-virus vaccine within 30 days before the first dose of trial treatment, during treatment with atezolizumab, or within 160 days after the last dose of atezolizumab (note: most standard flu shots do not contain live virus and may be acceptable; the nasal spray flu vaccine does contain live virus and is not permitted in that timeframe; non-live COVID-19 vaccines are permitted).
• People who are currently imprisoned or involuntarily detained, or held under compulsion for psychiatric or physical treatment.
• People whose tumors have a Tumour Mutation Burden (TMB) score of 10 or higher (a measure of the number of genetic changes in the tumour).
• People who have received any cancer-directed treatment (such as chemotherapy, radiation, immunotherapy, or certain ablation procedures) within 28 days before starting the trial.
• People with brain metastases (cancer spread to the brain) that have not been treated and remained stable for at least 90 days without steroids — people with any history or symptoms of brain metastases must have had a brain CT or MRI within 30 days before starting the trial.
• People with autoimmune diseases that currently require active treatment, or a history of severe autoimmune disease (people with stable, treated hypothyroidism, adrenal insufficiency, or pituitary insufficiency may still be eligible — confirm with trial site).
• People who are unable to stop taking medications that are known to interact with the study treatment.
• People with significant protein in the urine above a defined level (confirm with trial site).
• People with a prolonged heart electrical interval (QTc above 470) on an ECG at screening, a significantly abnormal ECG at screening, or a heart attack within 12 weeks before starting the trial.

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