Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2021-05-12
Brief Title:
Safety and Efficacy Study of Pembrolizumab MK-3475 Combined With Lenvatinib MK-7902E7080 as First-line Intervention in Adults With Advanced Melanoma MK-7902-003E7080-G000-312LEAP-003-China Extension Study
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab MK-3475 and Lenvatinib E7080MK-7902 Versus Pembrolizumab Alone as First-line Intervention in Participants With Advanced Melanoma LEAP-003
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
The purpose of the China Extension study is to assess the safety and efficacy of pembrolizumab MK-3475 combined with lenvatinib MK-7902E7080 compared to pembrolizumab alone with placebo for lenvatinib as first-line treatment in Chinese participants with no prior systemic therapy for their advanced melanoma
Detailed Description:
As of 03-Apr-2023 active participants investigator and sponsor personnel or delegates involved in the treatment administration or clinical evaluation of the participants will be unblinded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LEAP-003 | OTHER | Merck | None |
| MK-7902-003 | OTHER | None | None |
| E7080-G000-312 | OTHER | None | None |