Endoscopic Surgical Procedure Clinical Trial
Official title:
Phase II Study of Pembrolizumab in Combination With BCG After Endoscopic Ablation for Patients With High Risk Superficial Upper Urinary Tract Transitional Cell Carcinoma Unfit or Unwilling to be Treated With Nephroureterectomy
PURPOSE: This study is being conducted to test the safety of the study drug Pembrolizumab,
also known as MK-3475, at different dose levels in combination with the current therapy,
(BCG), for superficial upper urinary tract transitional cell carcinoma. We want to find out
what effects, good and/or bad, it has on upper urinary transitional cell carcinoma OBJECTIVE:
To determine the safety of administering MK-3475 at a fixed dose of 200 mg every three weeks
in conjunction with intrapelvic BCG treatment in high risk superficial UUTTCC patients who
are unfit or unwilling to be treated with radical nephroureterectomy.
STUDY DESIGN: Open-label, single center, Phase II, treatment trial TREATMENT: BCG- BCG
treatment could be delivered both through a retrograde ureteral catheter placed under
fluoroscopic control or through an antegrade nephrostomy tube placed by interventional
radiology. Treatment will be once a week for 6 weeks. BCG treatment will begin on Day 1 of
Week 7. Depending on patient's response, they may have additional treatments beyond the 6
scheduled, but they will be outside of the patient's participation in this study.
Pembrolizumab will be given through an intravenous needle once every 21 days (one cycle) for
a total of 6 cycles. It will take 30 minutes for the infusion of the study drug.
Pembrolizumab will be given on Day 1 of weeks 1, 4, 7, 10, 13, and 16 while BCG will be given
on Day 1 of weeks 7-12.
PROCEDURES: Following informed consent, prescreening and screening procedures will be
performed, which will include medical history review, baseline chest x ray and EKG,
ureteroscopy and pulmonary function tests for final eligibility status. Once subject is
eligible, they will undergo physical exams (every 3 weeks), vital signs and weight (each
study visit), adverse event monitoring (each study visit), ECGs (screening visit), bloodwork
(at screening and then every 3 weeks), urinalysis at selected study visits, and concomitant
medication review (each study visit), and questionnaires (selected study visits). After
subject has completed week 19, they will have a study discontinuation visit, followed by a 30
day follow up visit. The subject will then be followed at 3, 6, 9, 12, 18 and 24 months post
treatment where vital status will be determined as well as disease recurrence status.
Ureteroscopy will be performed as standard of care but will be considered measures for
efficacy. Biopsy will be performed as clinically indicated.
n/a
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