NCT05608291

A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

Active, enrolled Phase 3 Last updated 13 May 2025

What this trial tests

Phase 3 trial testing Fianlimab in Melanoma in 1,564 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 January 2023

Primary endpoint
16 May 2028

15 February 2030

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,564
Start date	16 January 2023
Primary completion	16 May 2028
Estimated completion	15 February 2030
Sites	211 locations across Italy, Ireland, Poland, Belgium, Mexico, United States, France, South Africa

Drugs / interventions tested

• Fianlimab — full drug profile →
• Cemiplimab (CEMIPLIMAB) — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →
• Placebo

Conditions studied

• Melanoma — all drugs for Melanoma →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

12 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab.

The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting.

The study is looking at several other research questions, including:

* What side effects may happen from receiving the study drugs.
* How much study drug is in the blood at different times.
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections.
* How administering the study drugs might improve quality of life.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. T cells in health and disease.
   Sun L, Su Y, Jiao A, Wang X, et al · · 2023 · cited 717× · PMID 37332039 · DOI 10.1038/s41392-023-01471-y
2. Harnessing the tumor microenvironment: targeted cancer therapies through modulation of epithelial-mesenchymal transition.
   Glaviano A, Lau HS, Carter LM, Lee EHC, et al · · 2025 · cited 90× · PMID 39806516 · DOI 10.1186/s13045-024-01634-6
3. Beyond CTLA-4 and PD-1 Inhibition: Novel Immune Checkpoint Molecules for Melanoma Treatment.
   Ziogas DC, Theocharopoulos C, Lialios PP, Foteinou D, et al · · 2023 · cited 58× · PMID 37345056 · DOI 10.3390/cancers15102718
4. Phase I Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced Melanoma.
   Hamid O, Lewis KD, Weise A, McKean M, et al · · 2024 · cited 29× · PMID 38900987 · DOI 10.1200/jco.23.02172
5. Deciphering T-cell exhaustion in the tumor microenvironment: paving the way for innovative solid tumor therapies.
   Nair R, Somasundaram V, Kuriakose A, Krishn SR, et al · · 2025 · cited 28× · PMID 40236693 · DOI 10.3389/fimmu.2025.1548234
6. LAG-3 : recent developments in combinational therapies in cancer.
   Chavanton A, Mialhe F, Abrey J, Baeza Garcia A, et al · · 2024 · cited 25× · PMID 38702996 · DOI 10.1111/cas.16205
7. Adjuvant therapy for stage II melanoma: the need for further studies.
   Lee R, Mandala M, Long GV, Eggermont AMM, et al · · 2023 · cited 22× · PMID 37301717 · DOI 10.1016/j.ejca.2023.05.003
8. Adjuvant immunotherapy for melanoma patients: progress and opportunities.
   Sussman TA, Ott PA. · · 2024 · cited 14× · PMID 38626633 · DOI 10.1016/j.esmoop.2024.102962