Ignite Creation Date:
2024-05-06 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03504163
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2018-04-11
Brief Title:
Pembrolizumab MK-3475 and Bacillus Calmette-Guérin BCG as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer NMIBC and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma NMI-UTUC
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Study of Pembrolizumab MK-3475 and Bacillus Calmette-Guérin BCG as First-Line Treatment for High-Risk T1 Non-Muscle- Invasive Bladder Cancer NMIBC and High- Grade Non-Muscle- Invasive Upper Tract Urothelial Cell Carcinoma NMI-UTUCC
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out the effectiveness of pembrolizumab in combination with BCG as a first line therapy for participants with high grade T1 bladder cancer who are at high risk for BCG alone to be ineffective and are seeking an alternative treatment option to radical cystectomy There is biologic rationale for combining pembrolizumab and BCG as two distinct immunotherapies with possible additive or synergistic activity in urothelial cancer The combination of pembrolizumab with BCG will also be evaluated in an exploratory cohort of patients with upper tract urothelial cancer
Detailed Description:
Patients will receive pembrolizumab MK-3475 administered after TUR in combination with BCG as initial therapy Pembrolizumab MK-3475 will be administered as a 400 mg IV infusion at 6-week intervals Q6W for 9 doses over a 48 week period unless there is unacceptable toxicity or other reasons that would warrant the discontinuation of treatment Patients will receive once-weekly BCG therapy TICE strain 50 mg for 6 consecutive weeks as a standard induction course given as intravesical BCG for patients with T1 bladder cancer and administered through a percutaneous nephrostomy tube in antegrade fashion for patients with high-grade NMI-UTUC consistent with standard clinical practice BCG will start on week 3 after the first infusion of pembrolizumab 400 mg to allow for initial priming of T cells to further enhance the effects of BCG treatment Initiation of induction BCG may be delayed up to 14 days if deemed clinically indicated by the treating physician due to side effects from TURBT or ureteroscopy and with permission from the Principal Investigator PI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None