Research & Trial Information
Protocol#: Alliance – A031701
Cancer Type: Bladder
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or EUA. The diagnostic TURBT sample must have been obtained within 60 days prior to registration.
- 10-20 unstained slides (10 micron thickness) of formalin-fixed paraffin-embedded (FFPE) pre-treatment diagnostic transurethral resection (TUR) specimen available (for sequencing), with 2 (5 micron) slides at the start and end of the 10-20 slides, for a total of 12-22 unstained slides. An FFPE block is also acceptable.
- Clinical stage T2-T4aN0/xM0 disease.
- Medically appropriate candidate for radical cystectomy as assessed by surgeon.
- No concomitant multifocal carcinoma in situ; a single focus is allowed.
- One focus of muscle-invasive bladder cancer and/or a tumor <5 cm in size.
- No clinical or radiographic evidence for locally advanced or metastatic disease.
- No prior anti-PD-1, anti PD-L1 therapies, or systemic chemotherapy (prior intravesical induction immunotherapy for non-muscle invasive disease is allowed, defined as BCG x6 treatments; BCG refractory disease, defined as disease recurrence within 3 months of BCG therapy, is not allowed).
- No prior radiation therapy to the bladder.
- No major surgery or radiation therapy <4 weeks of registration.
- Age ≥ 18 years.
- ECOG Performance Status 0-1.
- Step 2 Patient Registration Eligibility Criteria:
- Patients must have completed 4 or more cycles of protocol-directed chemotherapy.
- Step 3 Patient Registration Eligibility Criteria (only patients with a DDR gene alteration):
- Deleterious alteration within 1 or more of 9 pre-defined DDR genes within the pretreatment TURBT DNA.
- Cystoscopy and imaging performed to determine stage/treatment assignment.