Pembrolizumab in Combination With BCG After Ablation in Patients With UUTTCC Without Nephroureterectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03345134|
Recruitment Status : Unknown
Verified November 2017 by Shaheen Alanee, Henry Ford Health System.
Recruitment status was: Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|High Risk Superficial Upper Urinary Tract Transitional Cell Carcinoma Endoscopic Surgical Procedure Transitional Epithelial Cells||Drug: MK-3475 and BCG||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||November 30, 2017|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
Experimental: MK-3475 and BCG
Single treatment group of high risk superficial upper urinary tract transitional cell carcinoma; combination treatment with MK-3475 and BCG
Drug: MK-3475 and BCG
combination treatment with MK-3475 and BCG after endoscopic ablation
- Complete Response per ureteroscopy and pathological confirmation of tissue biopsy [ Time Frame: At 19 weeks ]
- Complete Response per ureteroscopy and pathological confirmation of tissue biopsy [ Time Frame: Up to 24 months ]
- Progression Free Survival per ureteroscopy and pathological confirmation of tissue biopsy [ Time Frame: Up to 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345134
|Contact: Shaheen Alanee, MD, MPH, MBA||313-399-8275||Salanee1@hfhs.org|
|Contact: Travis Wheeler, BAemail@example.com|
|United States, Michigan|
|Shaheen Alanee, MD, MPH, MBA|
|Detroit, Michigan, United States, 48202|
|Contact: Shaheen Alanee, MD, MPH, MBA 313-399-8275 firstname.lastname@example.org|