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Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
NCT03553836 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Placebo
Study Locations (20)
California
- UCSD Moores Cancer Center ( Site 0133) — La Jolla
- The Angeles Clinic and Research Institute ( Site 0029) — Los Angeles
- UCLA Hematology & Oncology ( Site 0130) — Los Angeles
- John Wayne Cancer Institute ( Site 0026) — Santa Monica
Illinois
- Northwestern Medical Group ( Site 0135) — Chicago
- The University of Chicago Medical Center ( Site 0007) — Chicago
- Advocate Medical Group-Park Ridge ( Site 0025) — Park Ridge
Massachusetts
- Massachusetts General Hospital ( Site 0126) — Boston
- Beth Israel Deaconess Medical Center ( Site 0141) — Boston
- Dana Farber Cancer Institute ( Site 0124) — Boston
Florida
- Mayo Clinic Florida ( Site 0024) — Jacksonville
- Moffitt McKinley Outpatient Center ( Site 0131) — Tampa
Georgia
- Winship Cancer Institute of Emory University ( Site 0046) — Atlanta
- Northside Hospital ( Site 0115) — Atlanta
Arizona
- University of Arizona Cancer Center ( Site 0121) — Tucson
Colorado
- University of Colorado Cancer Center ( Site 0027) — Aurora
Connecticut
- Yale University ( Site 0035) — New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 976 participants |
| Start Date | 2018-09-12 |
| Est. Completion | 2033-10-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03553836
The ClinicalTrials.gov registry entry for NCT03553836 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 976 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03553836 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Illinois, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03553836 about?
NCT03553836 is a clinical study titled "Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)". 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 c...
What is the current status of trial NCT03553836?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 976 participants. The study started on 2018-09-12. Estimated completion is 2033-10-12.
What conditions does trial NCT03553836 study?
This clinical trial studies the following conditions: Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03553836?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03553836?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03553836 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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