Phase Ib/II Study of Neoadjuvant Pembrolizumab With Gemcitabine-Cisplatin (Cisplatin-Eligible) or Gemcitabine (Cisplatin-Ineligible) in Subjects With T2-4aN0M0 Urothelial Cancer: HCRN GU14-188

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bladder cancer | Urothelial cancer | muscle-invasive bladder cancer | urothelial cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria
Histologically confirmed muscle invasive disease of the urinary bladder, renal pelvis, or ureters
Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial carcinoma with mixed histology/features
Clinical stage cT2-4aN0M0
Surgical evaluation that documents the plan for multimodality therapy with a consolidative radical cystectomy or nephroureterectomy
Have an archived tumor block available to submit unstained slides for PD-L1 expression, basal and luminal subtype analysis
If on full dose anticoagulants, must be on a stable regimen of warfarin or low molecular weight heparin for at least two weeks
Adequate organ function
All screening labs should be performed within 28 days of Cycle 1 Day 1
Exclusion Criteria
A non-surgical approach recommended by the treating urologist due to any reason
Currently participating in or has participated in a study of an investigational agent or using an investigational device within 28 days prior to study registration
Diagnosis of immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration
Has had chemotherapy, targeted small molecule therapy, or radiation therapy for urothelial carcinoma
Has known active central nervous system metastases and/or carcinomatous meningitis
Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
Known evidence of interstitial lung disease or active, non-infectious pneumonitis
Active infection requiring systemic therapy
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
Received therapy with hematopoietic growth factor such as G-CSF or GMCSF in the 14 days prior to registration
Received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 antibody
Known history of HIV
Known active Hepatitis B or Hepatitis C
Received a live vaccine within 30 days prior to the first dose of trial treatment

Recruitment Status

Open

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