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Enrolling by Invitation

NCT Number: NCT06848088

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Vincent's University Hospital, Dublin, Ireland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Treatment and study plan

Fianlimab+cemiplimab

Drug

No study drug administered in this observational study.

Other names: REGN3767, REGN2810, Libtayo®

Primary outcomes

  1. 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

Secondary outcomes

  1. Progressive-Free Survival (PFS)

    Time frame: Up to 4 years

  2. Objective Response Rate (ORR)

    Time frame: Up to 4 years

  3. Duration of Response (DOR)

    Time frame: Up to 4 years

  4. Disease Control Rate (DCR)

    Time frame: Up to 4 years

  5. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 4 years

  6. Severity of SAEs

    Time frame: Up to 4 years

  7. Incidence of treatment-related AEs

    Time frame: Up to 4 years

  8. Severity of treatment-related AEs

    Time frame: Up to 4 years

  9. 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

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 26, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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