Phase 1 Bladder Cancer Trial, Terminated

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 aged 18 or older, of any gender, who are willing and able to provide written consent before any procedures begin.
• People who have been diagnosed with a locally advanced or metastatic solid tumour cancer — including colorectal, head and neck, non-small cell lung, gastric, oesophageal, pancreatic, bladder, renal cell carcinoma, melanoma, triple-negative breast cancer, or ovarian/fallopian tube cancers (the specific cancer types accepted depend on which part of the trial a person enters).
• For some parts of the trial, people with certain colorectal, gastric-oesophageal, ovarian/fallopian tube, or pancreatic cancers may need to have results available showing the repair status of their tumour's DNA (known as MMR/MSS/MSI testing), which must be completed before treatment starts if not already done.
• For one expansion group, people whose advanced solid tumour has a specific genetic marker (MSI-H/dMMR) and who previously received a type of immunotherapy drug (a PD-1/PD-L1 inhibitor), showed at least some response or stable disease for 4 or more months on that treatment, but whose cancer has since progressed.
• People whose cancer has not responded to, or who could not tolerate, existing treatments that are known to be helpful for their condition.
• People whose cancer can be measured by standard imaging assessments.
• People who are well enough to carry out normal daily activities, as assessed using a standard scale (ECOG performance status of 0 or 1) (confirm with trial site).
• People whose doctor estimates they have a life expectancy of at least 3 months.
• People whose blood test results show that their bone marrow, liver, and kidneys are functioning at or above the minimum levels required by the trial.
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting the study drug.
• Women who could become pregnant must agree to use highly effective contraception from the time of consent until at least 9.5 months after the last dose of the main study drug, or 4 months after the last dose of pembrolizumab, whichever is later.
• Men with female partners who could become pregnant must agree to use a condom or practise complete abstinence from the time of consent until at least 6.5 months after the last dose of the main study drug, or 4 months after the last dose of pembrolizumab, whichever is later.
• People who are willing to have a tumour biopsy taken before starting treatment, and in some cases after at least one dose of the study drug, according to the treating institution's guidelines.

Who may not be able to join:

• People who are currently taking part in another interventional clinical trial.
• People who have previously been treated with a CD25 (IL-2R) antibody drug (confirm with trial site).
• People who have had a severe allergic reaction (Grade 3 or higher) to a therapeutic antibody in the past.
• People who have previously had a solid organ transplant or a bone marrow transplant from a donor.
• People with a history of significant autoimmune diseases such as rheumatoid arthritis, lupus, scleroderma, Sjögren's syndrome, or autoimmune vasculitis — although people with vitiligo, type 1 diabetes, managed thyroid conditions, or pituitary conditions requiring only hormone replacement may still be considered.
• People with a history of autoimmune nerve or brain conditions such as Guillain-Barré syndrome, myasthenia gravis, multiple sclerosis, or poliomyelitis.
• People who had a recent infection (within 4 weeks before starting treatment) caused by certain viruses or bacteria linked to a nerve condition called Guillain-Barré syndrome, including herpes simplex, chickenpox virus, Epstein-Barr virus, CMV, measles, influenza A, Zika, COVID-19 (SARS-CoV-2), and others — all participants must have a negative flu and COVID-19 test within 3 days before starting treatment.
• People who have HIV, hepatitis B, or hepatitis C and require antiviral medication to manage it.
• People with a history of severe skin reactions known as Stevens-Johnson syndrome or toxic epidermal necrolysis.
• People who have not sufficiently recovered from side effects of previous cancer treatments before starting the trial.
• People with active, symptomatic cancer that has spread to the brain or the lining of the brain — although people with previously treated, stable, symptom-free brain metastases may be considered if treatment was completed at least 4 weeks before starting the trial.
• People with significant fluid build-up in the body that requires draining, or a fluid build-up around the lungs causing breathlessness.
• People experiencing moderate to severe ongoing diarrhoea, or those with chronic bowel conditions such as irritable bowel syndrome or inflammatory bowel disease.
• People with an active infection that requires antibiotic treatment.
• People with active, uncontrolled bleeding problems or those on significant blood-thinning medication.
• People who are pregnant or currently breastfeeding.
• People with serious uncontrolled medical conditions, including severely uncontrolled high blood pressure, unstable angina, significant heart failure, recent heart attack or heart procedure within the past 6 months, severe heart rhythm problems, poorly controlled diabetes, active stomach or intestinal ulcers or bleeding, or severe chronic lung disease.
• People who have had major surgery, radiation, chemotherapy, or other cancer treatments within 14 days before starting the study drug (longer washout periods apply for certain treatments — confirm with trial site).
• People who have used another experimental drug within 14 days before starting the study drug.
• People who need ongoing immunosuppressive drugs or regular steroid tablets, except for replacement steroids for adrenal insufficiency or topical, inhaled, nasal, or eye steroid preparations.
• People who have received or plan to receive a live vaccine within 30 days before or during the trial.
• People with a heart condition involving a prolonged electrical signal in the heart (long QT syndrome or a QTcF interval of 480ms or more on an ECG at screening), unless this is due to a pacemaker or specific heart conduction issue.
• People with another active cancer, other than certain low-risk or non-invasive cancers as agreed by the trial medical team (confirm with trial site).
• People with any other significant medical condition that the investigating doctor considers would make participation unsafe or inappropriate.
• For the combination treatment part of the trial: people who could not tolerate immunotherapy checkpoint inhibitor drugs previously, or who have had a serious (Grade 3 or higher) immune-related side effect affecting the liver, kidneys, eyes, nerves, heart, joints, or blood from a previous immunotherapy treatment.
• For the combination treatment part of the trial: people who have had a history of non-infectious lung inflammation related to a previous systemic treatment and needed steroid treatment for it within the 6 months before joining.

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