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)

NCT03504163 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	45
Start date	2018-06-27
Completion	2026-04

Conditions

• Bladder Cancer

Interventions

• Pembrolizumab (MK-3475)
• Bacillus Calmette-Guérin (BCG)

Primary outcomes

• The proportion of patients who are disease-free — 6 months
  The primary objective for the high-risk T1 bladder cohort is to estimate the proportion of patients who remain free from high-grade recurrence (by urine cytology, cystoscopy ± biopsy) at 6 months from the start of treatment with pembrolizumab (MK-3475) and BCG

Countries

United States