Ignite Creation Date:
2024-05-06 @ 1:14 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01767454
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2013-01-10
Brief Title:
Study of Dabrafenib - Trametinib in Combination With Ipilimumab for V600EK Mutation Positive Metastatic or Unresectable Melanoma
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Phase 1 Study of the BRAF Inhibitor Dabrafenib - MEK Inhibitor Trametinib in Combination With Ipilimumab for Unresectable or Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2017-11
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 is an open-label multi-center dose-finding Phase 1 study that will enroll subjects at least 18 years old with unresectable or metastatic melanoma and BRAF V600 mutations The primary objective of the study is to describe the safety for the doublet therapy dabrafenib and ipilimumab and the triplet therapy dabrafenibtrametinib and ipilimumab Preliminary efficacy data will also be collected Subjects will be assigned to receive either the doublet combination dabrafenib and ipilimumab or the triplet combination dabrafenib trametinib and ipilimumab Subjects will be enrolled to dose-finding cohorts in the doublet combination dabrafenib ipilimumab in a sequential 33 fashion Following establishment of a dose for the doublet combination an expansion cohort will be opened At the same time enrollment to dose finding cohorts for the triplet combination dabrafenib trametinib ipilimumab will begin in a sequential 66 fashion Enrollment into triplet cohorts will take priority when both the doublet expansion arm and the triplet dose-finding arm are open for enrollment at the same time Approximately 9-24 subjects will be enrolled to the dose finding portion of the study Approximately 30 subjects will be enrolled to doublet expansion cohort and 30 subjects will be enrolled in the triplet expansion cohort A two-week run-in period without ipilimumab will be followed by 4 intravenous doses of ipilimumab at the recommended dose and schedule Oral daily dosing of dabrafenib or dabrafenib trametinib will continue from the two-week run-in through combination with ipilimumab and post-ipilimumab until no longer of clinical benefit in the opinion of the treating physician or until unacceptable AE or death
Detailed Description:
None
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