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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06848088

Enrollment

Registered

2025-02-26

Start date

2025-04-14

Completion date

2029-10-10

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Advanced Skin Cancer

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).

Interventions

DRUGFianlimab+cemiplimab

No study drug administered in this observational study.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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/

Design outcomes

Primary

Measure	Time frame
Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613	Up to 4 years

Secondary

Measure	Time frame
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
Severity of SAEs	Up to 4 years
Incidence of treatment-related AEs	Up to 4 years
Severity of treatment-related AEs	Up to 4 years
Incidence of anti-cancer therapies received since end of treatment with fianlimab and cemiplimab in study R3767-ONC-1613	Up to 4 years

Countries

Ireland, United States

Contacts

STUDY_DIRECTORClinical Trial Management

Regeneron Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026