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 aged 18 or older who are able to sign a consent form agreeing to take part
• People who weigh more than 30 kg
• People whose tumour shows a specific protein marker (FGFR1, 2, or 3) at a high level, detected through a special tissue test called RNAScope
• People who are well enough to carry out basic daily activities, as measured by a standard medical scale (ECOG score of 0, 1, or 2)
• People who have been confirmed through a tissue sample to have bladder cancer of the urothelial type (the most common kind), including cases where urothelial cancer makes up at least half of a mixed tumour
• People whose bladder cancer is at a stage that has grown into the bladder muscle but has not spread to lymph nodes or other parts of the body (roughly stage T2 to T4a, confirmed by a bladder procedure and scans)
• People who have refused cisplatin-based chemotherapy before surgery, or who are not suitable for it due to one or more of the following: reduced physical function, lower-than-required kidney function, significant hearing loss, significant nerve damage, or moderate-to-severe heart problems
• People who have previously received a type of immune therapy (anti-PD-1/PD-L1) for early-stage bladder cancer, provided that treatment finished more than 3 months before joining the trial
• People who are considered suitable and planned to undergo surgery to remove the bladder (radical cystectomy) according to their local hospital's guidelines
• People who can provide 30 unstained tissue slides from a previous bladder procedure, or who are willing to have a new tissue sample taken if older samples are not available (the sample must contain at least 20% active tumour cells)
• Women who have gone through menopause, or women who have a negative pregnancy test before joining
• Women who could become pregnant, and men, who are willing to use highly effective contraception (less than 1% failure rate) from the time of signing consent until 90 days after the last dose of the study drug, or to abstain completely
• People whose blood test results meet the following standards (confirm exact values with trial site):
  • Haemoglobin at least 9.0 g/dL
  • Neutrophil count above 1,500 per mm³
  • Platelet count at least 100 x 10⁹/L
  • Blood clotting levels within acceptable range (or within a safe therapeutic range if already on blood-thinning medication)
  • Liver function and bilirubin within acceptable limits
  • Phosphorus within normal range
  • Kidney function above a minimum threshold (creatinine clearance above 30 mL/min)
• People with a life expectancy of at least 12 weeks
• People who are willing and able to attend scheduled visits, treatments, and follow-up appointments for the full duration of the study

Who may not be able to join:

• Women who are pregnant or currently breastfeeding
• People of reproductive potential who are unwilling to use effective contraception from screening until 90 days after the last dose of the study drug
• People who are currently taking part in another clinical trial, or who have done so within the past 4 weeks before the first dose
• People whose bladder cancer originates in the upper urinary tract (upper tract urothelial carcinoma)
• People whose tumour contains a small-cell carcinoma component
• People with measurable cancer that has spread to lymph nodes or other parts of the body
• People currently receiving any other cancer treatment (such as chemotherapy, radiation, immunotherapy, or other cancer medicines)
• People who have previously received systemic (whole-body) chemotherapy for muscle-invasive bladder cancer at any point
• People who have previously received anti-PD-1/PD-L1 immune therapy or an FGFR-blocking drug for muscle-invasive bladder cancer (use for earlier-stage bladder cancer may be permitted if finished more than 3 months before joining, provided certain safety conditions are met — confirm with trial site)
• People who had a serious side effect from prior immunotherapy that caused it to be stopped permanently, or who have not fully recovered from prior immunotherapy side effects
• People who experienced a severe (Grade 3 or higher) immune-related side effect, or any immune-related nerve or eye problem, during prior immunotherapy
• People who needed strong immune-suppressing medicines (beyond low-dose steroids) to manage a side effect from prior immunotherapy, or who currently require more than 10 mg of prednisone (or equivalent) daily
• People who have recently had major surgery and have not yet adequately recovered
• People with another active cancer, except for low-risk prostate cancer that is being monitored without treatment ("watch and wait")
• People who have had a previous cancer that has been fully treated may still be eligible in some cases, at the doctor's discretion (confirm with trial site)
• People with active serious heart conditions, including: a heart attack or unstable chest pain within the past 3 months, unstable irregular heartbeat, decompensated heart failure, uncontrolled high blood pressure, or a specific heart rhythm measurement (QTcF) above 470 milliseconds on an ECG
• People with a medical condition that would prevent them from safely having bladder removal surgery
• People who have taken high-dose steroid medicines within the past 2 weeks (low-dose, inhaled, topical, or nasal steroids may be acceptable — confirm with trial site)
• People with active or previously documented autoimmune or inflammatory conditions (such as inflammatory bowel disease, lupus, rheumatoid arthritis, or similar conditions), with some exceptions such as vitiligo, stable thyroid conditions on replacement therapy, skin conditions not requiring systemic treatment, celiac disease controlled by diet, or conditions that have been inactive for more than 5 years (confirm with trial site)
• People with HIV who have a detectable viral level or low immune cell count in recent testing, or who have active tuberculosis
• People with a known history of hepatitis B or C where the virus is still detectable in the blood
• People with a history or current signs of abnormal calcium deposits forming in soft tissues or organs (such as kidneys, lungs, or heart)
• People with current eye conditions affecting the cornea or retina, confirmed by an eye examination
• People with uncontrolled disorders affecting calcium or phosphate levels in the body
• People who have taken certain medications that strongly affect how the study drug is processed by the body (specific drug interactions — confirm with trial site) within 7 days before the first dose
• People with other medical or psychiatric conditions that, in the treating doctor's opinion, could interfere with the study or their ability to complete it
• People with a known allergy or sensitivity to the study drugs or their ingredients
• People who have received a live vaccine within 30 days before the first dose (and live vaccines should not be given during the study or for 90 days after the last dose)
• People with other uncontrolled illnesses, active infections, or serious ongoing digestive conditions involving diarrhoea
• People with unresolved side effects (Grade 2 or higher) from previous cancer treatment, with some exceptions such as hair loss or certain stable lab values (confirm with trial site)
• People who have received an organ transplant from another person (allogeneic transplant)

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