Pembrolizumab: Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Placebo: Administered as an IV infusion every 3 weeks (Q3W)
This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/\~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo.
Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arizona Cancer Center ( Site 0121) | Tucson | Arizona | |
| UCSD Moores Cancer Center ( Site 0133) | La Jolla | California | |
| The Angeles Clinic and Research Institute ( Site 0029) | Los Angeles | California | |
| UCLA Hematology & Oncology ( Site 0130) | Los Angeles | California | |
| John Wayne Cancer Institute ( Site 0026) | Santa Monica | California | |
| University of Colorado Cancer Center ( Site 0027) | Aurora | Colorado | |
| Yale University ( Site 0035) | New Haven | Connecticut | |
| Mayo Clinic Florida ( Site 0024) | Jacksonville | Florida | |
| Moffitt McKinley Outpatient Center ( Site 0131) | Tampa | Florida | |
| Winship Cancer Institute of Emory University ( Site 0046) | Atlanta | Georgia | |
| Northside Hospital ( Site 0115) | Atlanta | Georgia | |
| Northwestern Medical Group ( Site 0135) | Chicago | Illinois | |
| The University of Chicago Medical Center ( Site 0007) | Chicago | Illinois | |
| Advocate Medical Group-Park Ridge ( Site 0025) | Park Ridge | Illinois | |
| University of Iowa Hospital and Clinics ( Site 0001) | Iowa City | Iowa | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047) | Baltimore | Maryland | |
| Massachusetts General Hospital ( Site 0126) | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center ( Site 0141) | Boston | Massachusetts | |
| Dana Farber Cancer Institute ( Site 0124) | Boston | Massachusetts | |
| Karmanos Cancer Institute ( Site 0111) | Detroit | Michigan | |
| Mayo Clinic [Rochester, MN] ( Site 0016) | Rochester | Minnesota | |
| Siteman Cancer Center ( Site 0143) | St Louis | Missouri | |
| Memorial Sloan Kettering ( Site 0006) | Harrison | New York | |
| Laura and Isaac Perlmutter Cancer Center ( Site 0137) | New York | New York | |
| Memorial Sloan Kettering Cancer Center ( Site 0142) | New York | New York | |
| Mount Sinai Medical Center ( Site 0038) | New York | New York | |
| University of Rochester ( Site 0019) | Rochester | New York | |
| The Lindner Center for Research and Education at The Christ Hospital ( Site 0004) | Cincinnati | Ohio | |
| Stephenson Cancer Center ( Site 0042) | Oklahoma City | Oklahoma | |
| Oregon Health & Science University ( Site 0032) | Portland | Oregon | |
| Children's Hospital of Pittsburgh UPMC ( Site 0144) | Pittsburgh | Pennsylvania | |
| UPMC Hillman Cancer Centers ( Site 0043) | Pittsburgh | Pennsylvania | |
| West Cancer Center - East Campus ( Site 0022) | Germantown | Tennessee | |
| University of Tennessee Medical Center Knoxville ( Site 0116) | Knoxville | Tennessee | |
| University of Texas-MD Anderson Cancer Center ( Site 0134) | Houston | Texas | |
| Inova Schar Cancer Institute ( Site 0014) | Fairfax | Virginia | |
| VCU Massey Cancer Center ( Site 0008) | Richmond | Virginia | |
| Seattle Cancer Care Alliance ( Site 0044) | Seattle | Washington | |
| University of Wisconsin Hospital and Clinics ( Site 0030) | Madison | Wisconsin | |
| Melanoma Institute Australia ( Site 0856) | North Sydney | New South Wales |
+ 119 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03553836 on ClinicalTrials.gov ↗ ← All trials in the UK