NCT06848088

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

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

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Fianlimab+cemiplimab	No study drug administered in this observational study.

Timeline

• Start date: 2025-04-14
• Primary completion: 2029-10-10
• Completion: 2029-10-10
• First posted: 2025-02-26
• Last updated: 2026-01-12

Locations

8 sites across 2 countries: United States, Ireland

Regulatory

• FDA-regulated drug study