Phase III Randomized Adjuvant Study of Pembrolizumab in Muscle Invasive and Locally Advanced Urothelial Carcinoma Versus Observation

April 7, 2020

Clinical Trial Information

PROTOCOL: Alliance-A031501

SCHEMA A031501

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

Eligibility:

Pre-registration:

  1. Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract.
  2. Paraffin tissue available for PD-L1 analysis.
  3. Patient must fit into one of the following three categories:
    • Patients who received neoadjuvant chemotherapy and pathologic stage at
    surgical resection is ≥ pT2 and/or N+
    OR
    • Patients who are not cisplatin-eligible (according to ≥ 1 of the following
    criteria: ECOG performance status of 2, creatinine clearance < 60 mL/min,
    grade ≥ 2 hearing loss, grade ≥ 2 neuropathy, or New York Heart Association
    Class III heart failure [38]) and pathologic stage at surgical resection is ≥ pT3
    or pN+)
    OR
    • Patients that decline adjuvant cisplatin-based or other systemic chemotherapy
    based on an informed discussion with the physician and pathologic stage at
    surgical resection is ≥ pT3 or pN+ .
  4. Radical resection of bladder cancer ≤16 weeks prior to preregistration.
  5. No evidence of residual cancer or mets after surgery.
  6. No measurable disease on cross-sectional imaging.
  7. No active autoimmune disease or history of autoimmune disease that may recur.
  8. No postoperative/adjuvant systemic therapy.
  9. No prior treatment with any therapy on the PD-1 Or PD-L1 axis.
  10. No, treatment with an investigational agent, major surgery,
    radiation therapy or neoadjuvant chemotherapy ≤4 weeks prior to pre-registration.
  11. Age ≥18 years.

Registration Eligibility Criteria:

  1. Central PD-L1 results available.

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