Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

Inclusion criteria

• . Males or female patient is aged ≥18 years.
• . Pathologically-proven, recurrent, primary, secondary or concomitant carcinoma in situ disease, defined by having either Ta or T1 with CIS, or CIS alone. In cases with T1 tumor lesions, muscularis propria tissue should be in the resected specimen to confirm that it is tumor-free.
• . Patient has undergone mapping of the bladder between Days -28 and -14, with at least one biopsy providing pathological confirmation of CIS of the bladder. Slides must be available for a central pathology review.
• . Patient has undergone bladder washing for cytology between Days -28 and -1. In patients in whom Ta or T1 lesion(s) were resected, the bladder washing must have occurred after the resection. Slides must be available for a central cytology review.
• . Patient has an ECOG performance status 0-2.
• . Patient has adequate bone marrow, hepatic, and renal function within 4 weeks before Day 0.
• . Patient has read and understood the informed consent form and is willing and able to give informed consent.
• . Patient fully understands the requirements of the study and is willing to comply with all study visits and assessments.

Exclusion criteria