Inclusion Criteria

A subject must meet all the following criteria to be eligible to participate in this trial.

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 present):

• Recurrence within 1 year, low-grade Ta
• Solitary low-grade Ta >3 cm
• Low-grade Ta, multifocala
• Solitary high-grade Ta, ≤3 cm
• Low-grade T1a

aRestage 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) Female subjects of reproductive potential must be willing to use effective contraception during treatment with IMP and for 6 months following the last dose and must have a negative urine or serum pregnancy test upon entry into this trial. Otherwise, female subjects must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile.

Effective contraception means that the subject, if sexually active, should be using a combination of 2 methods of birth control that are approved and recognised to be effective by regulatory agencies.

13) Male subjects with female partners of reproductive potential must be surgically sterile or willing to use effective contraception during treatment with IMP and for 3 months following the last dose. Effective contraception is defined in inclusion criterion 12.

14) Adequate laboratory values defined as:

• Hemoglobin greater or equal than 9 g/dL, without transfusion or erythroprotein dependency
• White blood cells (WBC) greater or equal than 4 x 109/L
• Absolute neutrophil count (ANC) greater or equal than1.5 x 109/L
• Platelets greater or equal than 75 x 109/L
• International Normalised Ratio (INR) or Prothrombin Time (PT) and Activated Partial

Thromboplastin Time (aPTT) less or equal than1.5 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) less or equal than 1.5 x ULN
• Alanine aminotransferase (ALT) less or equal than 1.5 x ULN
• Total bilirubin less or equal than 1.5 x ULN
• Calculated creatinine clearance greater or equal than 30ml/min