Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
NCT05352672Phase 3Active, not recruiting
- Lead sponsor
- Regeneron Pharmaceuticals (Industry)
- Enrollment
- 1,546 (actual)
- Start date
- 14 Jul 2022
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 16 Sep 2031
- Last update posted
- 22 Apr 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 4
Interventions
- Fianlimab Drug
- Cemiplimab Drug
- Pembrolizumab Drug
- Placebo Drug
Conditions and primary outcome
- Melanoma
Primary outcome
Progression-free survival (PFS) (Approximately 27 months)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
1 on PubMedNext-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy.
Journal of immunology research · 2026
PubMed 41811823 (opens in a new tab)DOI 10.1155/jimr/7864229 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT05352672 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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