Trials / Active Not Recruiting
Active Not RecruitingNCT03924856
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)
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)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 907 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle |
| DRUG | Gemcitabine | Gemcitabine 1000 mg/m\^2, IV infusion on Days 1 and 8 of each 21-day cycle |
| DRUG | Cisplatin | Cisplatin 70 mg/m\^2, IV infusion on Day 1 of each 21-day cycle |
| PROCEDURE | Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) | Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines. |
| DRUG | Placebo | Placebo to pembrolizumab by IV infusion, given on Day 1 of each 21-day cycle |
Timeline
- Start date
- 2019-06-13
- Primary completion
- 2026-01-26
- Completion
- 2026-09-01
- First posted
- 2019-04-23
- Last updated
- 2025-08-28
Locations
175 sites across 22 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Sweden, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03924856. Inclusion in this directory is not an endorsement.