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

NCT06848088 | Enrolling By Invitation Phase 2 FDA Drug

• 2 other identifiers: R3767-ONC-24662024-517729-20-00
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 8

Brief Summary

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).

Conditions

Melanoma

Keywords

Advanced Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613

  Up to 4 years

Secondary Outcomes (9)

• Progressive-Free Survival (PFS)

  Up to 4 years

• Objective Response Rate (ORR)

  Up to 4 years

• Duration of Response (DOR)

  Up to 4 years

• Disease Control Rate (DCR)

  Up to 4 years

• Incidence of Serious Adverse Events (SAEs)

  Up to 4 years

Study Arms (2)

With Disease Progression at Enrollment

OTHER

Drug: Fianlimab+cemiplimab

No Progressive Disease at Enrollment

OTHER

Drug: Fianlimab+cemiplimab

Interventions

Fianlimab+cemiplimab DRUG

No study drug administered in this observational study.

Also known as: REGN3767, REGN2810, Libtayo®

No Progressive Disease at Enrollment; With Disease Progression at Enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (8)

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, 90025, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49546, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

South Texas Oncology And Hematology

San Antonio, Texas, 78229, United States

Location

St. Vincent's University Hospital

Dublin, D04 T6F4, Ireland

Location

MeSH Terms

Conditions

Melanoma

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 26, 2025
• Study Start: April 14, 2025
• Primary Completion (Estimated): October 10, 2029
• Study Completion (Estimated): October 10, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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
• 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

Locations

IE (1); US (7)