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NCT06246916Not yet recruiting

A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma
Regeneron PharmaceuticalsPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Melanoma
Drug/Device/Intervention
fianlimab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Regeneron Pharmaceuticals
Timeline & enrollment
Phase
Phase 3
Start date
Jun 07, 2024
End date
Apr 14, 2033
Enrollment
560 participants
Primary outcome

Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR)

Summary

This study is researching an experimental drug called fianlimab (also known as REGN3767),
 combined with another medication called cemiplimab (also known as REGN2810), called study
 drugs. The study is focused on patients with a type of skin cancer known as melanoma. The
 aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab
 is in treating melanoma, in comparison with the combination of two medications, relatlimab
 and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment
 of melanoma in adults and children.
 
 The study is looking at several other research questions, including:
 
 - What side effects may happen from taking the study drugs.
 
 - How much study drug is in the blood at different times.
 
 - Whether the body makes antibodies against the study drugs (which could make the drug
 less effective or could lead to side effects)

ICD-10 classifications
Malignant melanoma of skinMelanoma in situ, unspecifiedMelanoma in situMelanoma and other malignant neoplasms of skinMalignant neoplasm: Malignant melanoma of skin, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06246916
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06246916 through Pure Global AI's free database. This Phase 3 trial is sponsored by Regeneron Pharmaceuticals and is currently Not yet recruiting. The study focuses on Melanoma. Target enrollment is 560 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.