A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
Public ClinicalTrials.gov record NCT06190951. 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 2 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV 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 cemiplimab alone. These types of immunotherapy study drugs are collectively known as immune checkpoint inhibitors. Immunotherapies are treatments that use the immune system to recognize and kill cancer cells. The study is focused on participants with a type of skin cancer known as melanoma. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to cemiplimab in participants with high-risk, resectable melanoma. Participants will receive treatment before surgery, undergo resection, and then will have the option to continue treatment after resection. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug(s). * How much study drug(s) is in the blood at different times. * Whether the body makes antibodies against the study drug(s) (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
- NCT06190951
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 151 participants
Conditions and interventions
Conditions
Interventions
- cemiplimab Drug
- Fixed Dose Combination (FDC) cemiplimab+fianlimab Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 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 18, 2024 (Actual)
- Primary completion
- Nov 2, 2026 (Estimated)
- Completion
- Dec 9, 2030 (Estimated)
- Last update posted
- Feb 10, 2026
2024 – 2030
United States locations
- U.S. sites
- 28
- U.S. states
- 15
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92093 | — |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90089 | — |
| Hoag Family Cancer Institute | Newport Beach | California | 92663 | — |
| California Pacific Medical Center Research Institute | San Francisco | California | 94115 | — |
| University of California San Francisco (UCSF) | San Francisco | California | 94143 | — |
| St John's Cancer Institute | Santa Monica | California | 90404 | — |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Yale University Cancer Center | New Haven | Connecticut | 06510 | — |
| Emory Healthcare, Emory Clinic | Atlanta | Georgia | 30322 | — |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute Brookline Avenue | Boston | Massachusetts | 02215 | — |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Northwell Health Cancer Institute | Lake Success | New York | 11042 | — |
| Duke Cancer Institute, University Hospital | Durham | North Carolina | 27710 | — |
| Seidman Cancer Center | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| The Ohio State University James Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| UT Southwestern/Simmons Comprehensive Cancer Center | Dallas | Texas | 75235 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
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 76 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06190951, 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 Feb 10, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06190951 live on ClinicalTrials.gov.