Badanie porównujące nadofaragene firadenovec ze standardowym leczeniem u dorosłych ze zwiększonym ryzykiem nawrotu lub pogorszenia się nienaciekającego nowotworu pęcherza moczowego

Kryteria włączenia kto może wziąć udział (14)

1. Willing and able to provide written consent for the trial, obtained prior to any trial-related procedures
2. Age 18 years or older at the time of consent
3. Newly diagnosed or recurrent intermediate risk (IR) non-muscle invasive bladder cancer (NMIBC) at screening as defined by American Urological Association (AUA)/Society of Urologic Oncology [SUO] Guideline (2020)
4. Has undergone complete transurethral resection of bladder tumor (TURBT; with or without peri-operative intravesical chemotherapy) within 60 days prior to randomization, with 1 of the following confirmed by a diagnostic pathology report (which should indicate whether lamina propria and muscularis propria are present as well as the degree of involvement, if presenta ):  Low-grade Ta, <12 months  Low-grade Ta, solitary and >3 cm  Low-grade Ta, multifocalb  High-grade Ta, solitary and ≤3 cm  Low-grade T1a,b a Patients with T1 disease should undergo resection at the base of the lesion and biopsies should contain muscle fibres. b Restage TURBT may be done at the discretion of the investigator.
5. Must adhere to applicable (regional or national) policies and procedures for the management and control of COVID-19
6. Life expectancy of >2 years
7. Have a normal upper urinary tract (as evidenced by ultrasound, computed tomography (CT) urography or other appropriate test within 1 year prior to randomization) and no evidence of tumor in prostatic urethra
8. Eastern Cooperative Oncology Group (ECOG) status of 2 or less
9. Subjects with prostate cancer on active surveillance at low risk for progression, defined as prostate-specific antigen (PSA) <10 ng/mL, Gleason score 6 and cT1 are permitted to be included into the trial at the discretion of the investigator
10. Subjects with prostate cancer which has previously been treated with radiation therapy are eligible, if the radiation therapy was complete at least 1 years prior to randomization and the subject has remained disease free
11. Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of investigational medicinal product (IMP). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
12. Females of reproductive potential must meet 1 of the following conditions:  Have a negative highly sensitive urine or serum pregnancy test upon entry into this trial and be willing to use highly effective contraceptiona during treatment with the IMP and for 6 months following the last dose. For sites in Japan only, contraception should be approved in Japan.  Be postmenopausal (no menstrual period for a minimum of 12 months, as confirmed by follicle-stimulating hormone levels). For sites in Japan only, postmenopausal women should be 45 years or older.  Be surgically sterileb . a Highly effective methods of contraception include: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, and sexual abstinence. Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the female subject and that the vasectomised partner has received medical assessment of the surgical success. Sexual abstinence is defined as refraining from heterosexual intercourse. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. b The methods acceptable for surgical sterility are hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
13. Male subjects must be willing to use a male condom and effective contraception during sex throughout the treatment period and for 3 months following the last dose. Effective contraception is defined in inclusion criterion 12.
14. Adequate laboratory values defined as:  Hemoglobin ≥9 g/dL, without transfusion or erythropoietin dependency  White blood cells (WBC) ≥4 x 109 /L  Absolute neutrophil count (ANC) ≥1.5 x 109 /L  Platelets ≥75 x 109 /L  International Normalised Ratio (INR) or Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) ≤1.5 x upper limit of normal (ULN), unless subject is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants  Aspartate aminotransferase (AST) ≤1.5 x ULN  Alanine aminotransferase (ALT) ≤1.5 x ULN  Total bilirubin ≤1.5 x ULN  Calculated creatinine clearance ≥30ml/min  Estimated glomerular filtration rate (eGFR) ≥30ml/min/1.73m2 Inclusion criteria 3 and 4 are considered key.