A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients with Muscle Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response Gene Alterations

July 27, 2022

Protocol: Alliance A031701

Schema – A031701

Please Note: Below is a partial list of eligibility, please contact GHCI Research Department for full eligibility requirements.  Thank you!


  1. 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.
  2. Clinical stage T2-T4aN0/xM0 disease.
  3. Medically appropriate candidate for radical cystectomy as assessed by surgeon.
  4. No concomitant multifocal carcinoma in situ; a single focus is allowed.
  5. A single muscle-invasive bladder tumor measuring ≤5 cm in size as defined by the surgeons at cystoscopic evaluation. When documented, pathologic size at
    cystoscopy and TURBT will take precedence over radiographic measurements of tumor size.
  6. No clinical or radiographic evidence for locally advanced or metastatic disease.
  7. No prior anti-PD-1 or anti PD-L1 therapies, or systemic chemotherapy within the past 5 years (prior intravesical induction immunotherapy for non-muscle invasive
    disease is allowed, defined as BCG x6 doses and maintenance therapy); BCG refractory disease, defined as disease recurrence within 3 months of BCG therapy,
    is not allowed. Intravesical chemotherapy is allowed.
  8. No prior radiation therapy to the bladder or prostate.
  9. Age ≥ 18 years.
  10. ECOG Performance Status 0-1.

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