Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
Public ClinicalTrials.gov record NCT03553836. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03553836
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 976 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 12, 2018 (Actual)
- Primary completion
- Jun 21, 2021 (Actual)
- Completion
- Oct 12, 2033 (Estimated)
- Last update posted
- Nov 29, 2024
2018 – 2033
United States locations
- U.S. sites
- 39
- U.S. states
- 23
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona Cancer Center ( Site 0121) | Tucson | Arizona | 85719 | — |
| UCSD Moores Cancer Center ( Site 0133) | La Jolla | California | 92037 | — |
| The Angeles Clinic and Research Institute ( Site 0029) | Los Angeles | California | 90025 | — |
| UCLA Hematology & Oncology ( Site 0130) | Los Angeles | California | 90095 | — |
| John Wayne Cancer Institute ( Site 0026) | Santa Monica | California | 90404 | — |
| University of Colorado Cancer Center ( Site 0027) | Aurora | Colorado | 80045 | — |
| Yale University ( Site 0035) | New Haven | Connecticut | 06511 | — |
| Mayo Clinic Florida ( Site 0024) | Jacksonville | Florida | 32224 | — |
| Moffitt McKinley Outpatient Center ( Site 0131) | Tampa | Florida | 33612 | — |
| Winship Cancer Institute of Emory University ( Site 0046) | Atlanta | Georgia | 30322-1013 | — |
| Northside Hospital ( Site 0115) | Atlanta | Georgia | 30341 | — |
| Northwestern Medical Group ( Site 0135) | Chicago | Illinois | 60611 | — |
| The University of Chicago Medical Center ( Site 0007) | Chicago | Illinois | 60637 | — |
| Advocate Medical Group-Park Ridge ( Site 0025) | Park Ridge | Illinois | 60068 | — |
| University of Iowa Hospital and Clinics ( Site 0001) | Iowa City | Iowa | 52242 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047) | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital ( Site 0126) | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center ( Site 0141) | Boston | Massachusetts | 02215 | — |
| Dana Farber Cancer Institute ( Site 0124) | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Institute ( Site 0111) | Detroit | Michigan | 48201 | — |
| Mayo Clinic [Rochester, MN] ( Site 0016) | Rochester | Minnesota | 55905 | — |
| Siteman Cancer Center ( Site 0143) | St Louis | Missouri | 63110 | — |
| Memorial Sloan Kettering ( Site 0006) | Harrison | New York | 10604 | — |
| Laura and Isaac Perlmutter Cancer Center ( Site 0137) | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center ( Site 0142) | New York | New York | 10022 | — |
| Mount Sinai Medical Center ( Site 0038) | New York | New York | 10029 | — |
| University of Rochester ( Site 0019) | Rochester | New York | 14642 | — |
| The Lindner Center for Research and Education at The Christ Hospital ( Site 0004) | Cincinnati | Ohio | 45219 | — |
| Stephenson Cancer Center ( Site 0042) | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health & Science University ( Site 0032) | Portland | Oregon | 97239 | — |
| Children's Hospital of Pittsburgh UPMC ( Site 0144) | Pittsburgh | Pennsylvania | 15224 | — |
| UPMC Hillman Cancer Centers ( Site 0043) | Pittsburgh | Pennsylvania | 15232 | — |
| West Cancer Center - East Campus ( Site 0022) | Germantown | Tennessee | 38138 | — |
| University of Tennessee Medical Center Knoxville ( Site 0116) | Knoxville | Tennessee | 37920 | — |
| University of Texas-MD Anderson Cancer Center ( Site 0134) | Houston | Texas | 77030 | — |
| Inova Schar Cancer Institute ( Site 0014) | Fairfax | Virginia | 22031 | — |
| VCU Massey Cancer Center ( Site 0008) | Richmond | Virginia | 23298 | — |
| Seattle Cancer Care Alliance ( Site 0044) | Seattle | Washington | 98109 | — |
| University of Wisconsin Hospital and Clinics ( Site 0030) | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 120 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03553836, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 29, 2024 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03553836 live on ClinicalTrials.gov.