Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab: Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Placebo: Administered as an IV infusion every 3 weeks (Q3W)
Study summary
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.
Eligibility
Primary outcome measure(s)
- Recurrence-free Survival (RFS) — Up to ~32.7 months
RFS was defined as the time from randomization to any of the following events: recurrence of melanoma at any site (local, in-transit or regional lymph nodes or distant recurrence) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per protocol, final analysis for this primary outcome measure was performed using the initial pembrolizumab or placebo treatment with a protocol-specified analysis data cut-off date of June-21-2021.
Trial sites (159)
| 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.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Merck Sharp & Dohme LLC trials in Israel
Other trials for the same condition
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 Israel