A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment

July 10, 2026 updated by: Regeneron Pharmaceuticals

Extended Follow-up of Patients With Melanoma Treated With Fianlimab Plus Cemiplimab in Expansion Cohorts From Study R3767-ONC-1613

This study is researching the long-term effects of a combination of experimental drugs called fianlimab and cemiplimab. The study is being conducted in patients with advanced skin cancer (melanoma) who had previously been treated with fianlimab and cemiplimab in the study called R3767-ONC-1613 (NCT03005782).

The aim of the current study is to see how safe and effective the study drugs are in a long-term follow-up. No study drug will be given during this study. Cancer status will be monitored, in addition to routine care. The study is also collecting information about general health status, and other treatments that may have been received since participation in study R3767-ONC-1613 (NCT03005782).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, D04 T6F4
        • St. Vincent's University Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic and Research Institute - West Los Angeles Office
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University Of Kansas Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49546
        • Cancer & Hematology Centers of Western Michigan
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of New Jersey
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Oncology And Hematology
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Care Specialist, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

1. Participants with melanoma who enrolled in cohorts 6, 15, or 16 of study R3767-ONC- 1613 (NCT03005782)

Key Exclusion Criteria:

None

Note: Other protocol-defined Inclusion/ Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: With Disease Progression at Enrollment
Drug: Fianlimab+cemiplimab
No study drug administered in this observational study.
Other Names:
  • REGN2810
  • REGN3767
  • Libtayo®
Other: No Progressive Disease at Enrollment
Drug: Fianlimab+cemiplimab
No study drug administered in this observational study.
Other Names:
  • REGN2810
  • REGN3767
  • Libtayo®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613
Time Frame: Up to 4 years
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Response (DOR)
Time Frame: Up to 4 years
Up to 4 years
Objective Response Rate (ORR)
Time Frame: Up to 4 years
Up to 4 years
Progressive-Free Survival (PFS)
Time Frame: Up to 4 years
Up to 4 years
Disease Control Rate (DCR)
Time Frame: Up to 4 years
Up to 4 years
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 4 years
Up to 4 years
Severity of SAEs
Time Frame: Up to 4 years
Up to 4 years
Incidence of treatment-related AEs
Time Frame: Up to 4 years
Up to 4 years
Severity of treatment-related AEs
Time Frame: Up to 4 years
Up to 4 years
Incidence of anti-cancer therapies received since end of treatment with fianlimab and cemiplimab in study R3767-ONC-1613
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2025

Primary Completion (Estimated)

October 10, 2029

Study Completion (Estimated)

October 10, 2029

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R3767-ONC-2466
  • 2024-517729-20-00 (Ctis: EUCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe