A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery
Public ClinicalTrials.gov record NCT05608291. 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
A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs. * How much study drug is in the blood at different times. * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life.
Study identification
- NCT ID
- NCT05608291
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,564 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
- Jan 16, 2023 (Actual)
- Primary completion
- Jul 27, 2026 (Estimated)
- Completion
- Apr 3, 2030 (Estimated)
- Last update posted
- Jul 6, 2026
2023 – 2030
United States locations
- U.S. sites
- 28
- U.S. states
- 15
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92093 | — |
| UCSF Medical Center at Mission Bay | San Francisco | California | 94158 | — |
| John Wayne Cancer Institute (JWCI) | Santa Monica | California | 90404 | — |
| The Melanoma And Skin Cancer Institute | Englewood | Colorado | 80113 | — |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | 33176 | — |
| Orlando Health | Orlando | Florida | 32806 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | — |
| Columbia University | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Duke Cancer Institute, University Hospital | Durham | North Carolina | 27710 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| The Ohio State University James Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| St Lukes University Health Network | Easton | Pennsylvania | 18045 | — |
| University Of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Tennessee Oncology - Centennial Clinic Location | Nashville | Tennessee | 37203-1625 | — |
| Verdi Oncology | Nashville | Tennessee | 37203 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22903 | — |
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 183 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05608291, 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 Jul 6, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05608291 live on ClinicalTrials.gov.