Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716) (NCT03553836)
Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arizona Cancer Center ( Site 0121) — Tucson, Arizona
Age range: 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (159 Sites)
Showing the first 25 of 159 sites.
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Melanoma
- Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy — San Francisco, California
- An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942) — Tucson, Arizona
- Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. — CABA, Buenos Aires
- Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients — Santa Monica, California
- NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma — Boston, Massachusetts
- A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma — Orlando, Florida
Explore by condition: All Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.