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 are willing and able to give written consent to participate.
• People who are able to follow the study requirements, including regularly completing quality-of-life questionnaires.
• People aged 18 or older.
• People who have been diagnosed through a tissue biopsy with urothelial carcinoma (cancer of the bladder, renal pelvis, ureter, or urethra) that cannot be removed by surgery and has either spread locally or to other parts of the body. Some mixed cancer cell types are permitted, as long as urothelial cancer is part of the diagnosis.
• People whose cancer can be measured on scans using a standard measurement system called RECIST v1.1.
• People whose doctors consider them suitable for chemotherapy using either gemcitabine/cisplatin or gemcitabine/carboplatin. Carboplatin may be used instead of cisplatin for people who have reduced kidney function, a lower performance score, significant hearing loss, or a certain level of heart failure (confirm with trial site for specific thresholds).
• People with an ECOG performance status score of 0, 1, or 2 — meaning they are fully active, have some limitations but can care for themselves, or are limited in activity but up and about for more than half of waking hours.
• People with adequate blood counts and organ function as assessed by the trial site.
• Women who could become pregnant must have a negative pregnancy test within 2 weeks before starting the trial.
• People who agree to use reliable contraception during the trial.

Who may not be able to join:

• People who have previously been treated with a PD-(L)-1 inhibitor (a type of immunotherapy) for advanced cancer. However, prior use of this type of immunotherapy as part of earlier-stage treatment for urothelial cancer is permitted.
• People who have already received systemic (whole-body) treatment for locally advanced or metastatic urothelial carcinoma, unless it was a platinum-based chemotherapy given before or after surgery and finished more than 6 months ago.
• People who are pregnant or breastfeeding.
• People with active cancer that has spread to the brain or spinal cord. People with previously treated and stable brain metastases may be permitted (confirm with trial site).
• People who have had an organ transplant or bone marrow transplant from a donor.
• People who have received a live vaccine within 4 weeks before joining, or who may need one during the trial.
• People who have received certain immune-stimulating treatments (such as interferon or IL-2) within 4 weeks, or within five half-lives of the drug, before joining.
• People currently taking part in another clinical trial involving a treatment, or who have done so within 4 weeks before joining.
• People with serious uncontrolled medical conditions that could affect their ability to follow the study or affect results, such as severe liver disease, uncontrolled seizures, or blockage of a major vein near the heart.
• People who have had another type of cancer within the past 3 years, with some exceptions for cancers considered very low risk or treated with curative intent (such as certain skin cancers, early cervical cancer, or some prostate cancers — confirm with trial site).
• People with significant heart conditions, including moderate-to-severe heart failure, a heart attack or stroke within the past 6 months, or unstable heart rhythm or chest pain.
• People who have had radiotherapy within 2 weeks before starting, or who have not fully recovered from its side effects.
• People who have had major surgery (requiring general anaesthetic and more than 24 hours in hospital) within 4 weeks before joining, or who have not fully recovered from it.
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, drug-induced lung inflammation, or organising pneumonia, or who currently show signs of lung inflammation on a chest scan.
• People with active hepatitis B or hepatitis C infection. People with a past hepatitis B infection that has resolved may be eligible (confirm with trial site).
• People who test positive for HIV.
• People with active tuberculosis.
• People with an active autoimmune disease (where the immune system attacks the body), such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or similar conditions.
• People with a history of autoimmune-related thyroid problems, unless their thyroid hormone levels are stable on a consistent medication dose.
• People with a history of severe allergic reactions to chimeric or humanised antibodies (a type of laboratory-made protein used in some medicines).
• People with a known allergy to avelumab or any of its ingredients, including products made using Chinese hamster ovary cells (a common method used in making biological medicines).
• People with an active infection currently requiring treatment with systemic (whole-body) antibiotics or other medicines.
• People with ongoing significant side effects from previous treatments (above a mild level), with some exceptions for hair loss or mild nerve-related symptoms.
• People with any other condition that, in the investigator's opinion, would interfere with the study or with assessing safety and results.
• People with a known allergy to cisplatin, carboplatin, gemcitabine, or any related chemotherapy ingredients.
• People with tumours that are actively bleeding.
• People with any other medical reason that would make gemcitabine/cisplatin or gemcitabine/carboplatin chemotherapy unsuitable for them.

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