Phase II Trial of Intravesical Gemcitabine and Pembrolizumab in Treatment of Patients with BCG Unresponsive Non-Muscle Invasive Bladder Cancer

April 7, 2020

Clinical Trial Information

PROTOCOL: Alliance-A031803

SCHEMA A031803

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.


  1. High grade Ta, T1 or CIS urothelial carcinoma and Recurrent disease after completing therapy with at least induction BCG
    (≥5 doses) and the first round of maintenance or second induction course (≥2 doses).
  2. Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy.
  3. All visible tumor must be completely resected within 60 days of before registration (residual pure CIS is permitted).
  4. All patients must have histologically confirmed urothelial cancer of the bladder within 60 days after starting BCG.
  5. All patients must have had a cystoscopy without papillary tumor and negative urinary cytology within 21 days before
    registration. (Positive cytology is allowed in patients with pure CIS).
  6. Mixed variant histology (adenocarcinoma, squamous cell carcinoma)
  7. Patients with T1 tumors must undergo a re-staging TURBT within 60 days before registration.
  8. No evidence of metastasis documented with CT or MRI abd/pelvis within 90 days prior to registration.
  9. No history of urothelial carcinoma in the ureters or prostatic urethra within 24 months of registration.
  10. No prior or concurrent systemic chemotherapy or immunotherapy. (Prior intravesical chemo and interferon is allowed. Single dose chemotherapy post TURBT is allowed.)
  11. No prior bladder radiation.
  12. Age ≥ 18 years.
  13. ECOG Performance Status: 0-2.
  14. No known additional malignancy that has had progression or has required active treatment in the last three years.
  15. History of prostate cancer that was treated with definitive intent is allowed.
  16. No active autoimmune disease requiring systemic treatment within 24 months prior to registration.

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