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October 11, 2019 Bladder

Research & Trial Information

SCHEMA A031701

Protocol#: Alliance – A031701

Cancer Type: Bladder

Patient Eligibility:

  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. 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.
  3. Clinical stage T2-T4aN0/xM0 disease.
  4. Medically appropriate candidate for radical cystectomy as assessed by surgeon.
  5. No concomitant multifocal carcinoma in situ; a single focus is allowed.
  6. One focus of muscle-invasive bladder cancer and/or a tumor <5 cm in size.
  7. No clinical or radiographic evidence for locally advanced or metastatic disease.
  8. 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).
  9. No prior radiation therapy to the bladder.
  10. No major surgery or radiation therapy <4 weeks of registration.
  11. Age ≥ 18 years.
  12. ECOG Performance Status 0-1.
  13. Step 2 Patient Registration Eligibility Criteria:
  14. Patients must have completed 4 or more cycles of protocol-directed chemotherapy.
  15. Step 3 Patient Registration Eligibility Criteria (only patients with a DDR gene alteration):
  16. Deleterious alteration within 1 or more of 9 pre-defined DDR genes within the pretreatment TURBT DNA.
  17. Cystoscopy and imaging performed to determine stage/treatment assignment.


October 11, 2019 Bladder

Research & Trial Information

SCHEMA A031501

Protocol#: Alliance – A031501

Cancer Type: Bladder

Patient Eligibility:

  1. Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract or LN+ disease. Variant histology allowed as long as urothelial carcinoma is predominant (any amount of squamous differentiation is allowed). Pure small-cell carcinoma is excluded.
  2. Paraffin tissue samples obtained by transurethral resection of muscle-invasive bladder tumor, upper tract resection, or radical cystectomy/nephrectomy/ureterectomy/nephroureterectomy must be available. This specimen submission is mandatory prior to registration as results will be used for stratification. Specimens from radical/definitive surgery (radical  ystectomy/nephrectomy/ureterectomy/nephroureterectomy and LN dissection) are preferred over transuretheral resection, if available.
  3. Patient must fit into one of the following three categories: surgical resection is ≥ pT2 and/or N+Patients who received neoadjuvant chemotherapy and pathologic stage at 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. Patient must have had radical cystectomy, nephrectomy, nephroureterectomy or ureterectomy ≥4 weeks but ≤ 16 weeks prior to pre-registration.
  5. No gross cancer at the surgical margins. Microscopic invasive positive margins are allowed. CIS at margins is considered negative margins.
  6. No evidence of residual cancer or metastasis after surgery.
  7. No postoperative/adjuvant systemic therapy.
  8. No prior treatment with any therapy on the PD-1/PD-L1 axis.
  9. No treatment with any other type of investigational agent ≤ 4 weeks before preregistration.
  10. No major surgery ≤ 4 weeks before pre-registration.
  11. No radiation therapy ≤ 4 weeks before pre-registration.
  12. No neoadjuvant chemotherapy ≤ 4 weeks before pre-registration.
  13. Not currently requiring hemodialysis.
  14. Age ≥ 18 years
  15. ECOG Performance Status ≤ 2.
  16. Results of central PD-L1 testing available.

 


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Flint, MI 48503

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Hurley Medical Center
Michigan Cancer Consortium

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