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

NCT ID: NCT06848088

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-14

Study Completion Date

2029-10-10

Brief Summary

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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).

Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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With Disease Progression at Enrollment

Group Type OTHER

Fianlimab+cemiplimab

Intervention Type DRUG

No study drug administered in this observational study.

No Progressive Disease at Enrollment

Group Type OTHER

Fianlimab+cemiplimab

Intervention Type DRUG

No study drug administered in this observational study.

Interventions

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Fianlimab+cemiplimab

No study drug administered in this observational study.

Intervention Type DRUG

Other Intervention Names

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REGN3767 REGN2810 Libtayo®

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, United States

Site Status

California Pacific Medical Center

San Francisco, California, United States

Site Status

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

South Texas Oncology And Hematology

San Antonio, Texas, United States

Site Status

St. Vincent's University Hospital

Dublin, , Ireland

Site Status

Countries

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United States Ireland

Other Identifiers

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2024-517729-20-00

Identifier Type: CTIS

Identifier Source: secondary_id

R3767-ONC-2466

Identifier Type: -

Identifier Source: org_study_id

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