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

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Regeneron Pharmaceuticals

Status and phase

Invitation-only
Phase 2

Conditions

Melanoma

Treatments

Drug: Fianlimab+cemiplimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06848088
2024-517729-20-00 (Registry Identifier)
R3767-ONC-2466

Details and patient eligibility

About

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).

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

With Disease Progression at Enrollment
Other group
Treatment:
Drug: Fianlimab+cemiplimab
No Progressive Disease at Enrollment
Other group
Treatment:
Drug: Fianlimab+cemiplimab

Trial contacts and locations

2

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Central trial contact

Clinical Trials Administrator

Data sourced from clinicaltrials.gov

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