Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866) (KEYNOTE-866)
Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866) (KEYNOTE-866)
Brief Summary:
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 870 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-866)
Actual Study Start Date: June 13, 2019
Estimated Primary Completion Date: June 15, 2025
Estimated Study Completion Date: June 15, 2025
Arm:
- Experimental: Pembrolizumab + Gemcitabine + Cisplatin + Surgery
- Placebo Comparator: Placebo + Gemcitabine + Cisplatin + Surgery
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 870 |
| Actual Study start date | 13 June 2019 |
| Estimated Study Completion Date | 15 June 2025 |