Enrolling by invitation

Long-term Effects of Fianlimab and Cemiplimab in Advanced Melanoma

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What is being tested

Fianlimab+cemiplimab

Drug
Who is being recruted

Melanoma+9

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
See all eligibility criteria
How is the trial designed

Other Study

Phase 2
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorRegeneron Pharmaceuticals
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 14, 2025

Actual date on which the first participant was enrolled.

This study focuses on understanding the long-term safety and effectiveness of two experimental drugs, fianlimab and cemiplimab, in individuals with advanced melanoma, a serious form of skin cancer. Participants in this study have previously been treated with these drugs in an earlier study. The research aims to gather information on how these drugs impact the health of patients over a longer period, which can help improve future treatment strategies and provide better care for melanoma patients. During this study, participants will not receive any new doses of fianlimab or cemiplimab. Instead, their health will be closely monitored to observe the status of their cancer and gather data on their overall well-being. The study will also collect details about any other treatments participants might have received after the previous study. This approach helps researchers evaluate the lasting effects of the drugs without introducing new interventions, ensuring a focus on long-term health outcomes.

Official TitleExtended Follow-up of Patients With Melanoma Treated With Fianlimab Plus Cemiplimab in Expansion Cohorts From Study R3767-ONC-1613
NCT06848088
Principal SponsorRegeneron Pharmaceuticals
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Group II

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Suspended

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, United StatesOpen The Angeles Clinic and Research Institute - West Los Angeles Office in Google Maps
Suspended

California Pacific Medical Center

San Francisco, United States
Suspended

University of Colorado Anschutz Medical Campus

Aurora, United States
Suspended

Henry Ford Hospital

Detroit, United States
Enrolling by invitation8 Study Centers