Ignite Creation Date:
2024-05-06 @ 2:37 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02083484
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2018-01-26
First Post:
2014-03-07
Brief Title:
Program for Pembrolizumab MK-3475 in Participants With Metastatic Melanoma Who Have Failed Standard of Care Therapy Including Ipilimumab MK-3475-030
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Expanded Access of MK-3475 in Metastatic Melanoma Patients With Limited to No Treatment Options
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an expanded access program EAP for participants who have progressed after prior systemic therapy including ipilimumab and V-raf murine sarcoma viral oncogene homolog B1 BRAF inhibitor or mitogen-activated protein kinase MEK enzyme inhibitor when indicated Participants cannot be eligible for or have participated in any pembrolizumab MK-3475 clinical trial with the exception of a participant enrolled in the pembrolizumab protocol MK-3475-006 who received treatment on the ipilimumab treatment arm and progressed such participants will be eligible to participate in the EAP regardless of prior treatment with a BRAFMEK inhibitor as long as all other eligibility criteria for MK-3475-030 are met
Detailed Description:
Pembrolizumab has been approved by the US Food and Drug Administration for the treatment of patients with unresectable metastatic melanoma and disease progression following ipilimumab and if BRAF V600 mutation positive a BRAF inhibitor The Expanded Access Program EAP for this medicine in the US is closed The EAP will continue outside the US
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None