Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06246916
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-01-30
Brief Title:
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None