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A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma - Trial NCT06246916

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.

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NCT06246916
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06246916
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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

Study Focus

Melanoma

fianlimab

Interventional

drug

Sponsor & Location

Regeneron Pharmaceuticals

Timeline & Enrollment

Phase 3

Jun 07, 2024

Apr 14, 2033

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 Opdualagโ„ข 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 skin
Melanoma in situ, unspecified
Melanoma in situ
Melanoma and other malignant neoplasms of skin
Malignant neoplasm: Malignant melanoma of skin, unspecified

Data Source

ClinicalTrials.gov

NCT06246916

Non-Device Trial