Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05767879
Status:
RECRUITING
Last Update Posted:
2023-03-14
First Post:
2022-08-16
Brief Title:
NeoAdjuvant BRAFMEK Inhibition in pN1c Melanoma
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Open Label Phase 2 Study Neo-Adjuvant BRAFMEK Inhibition Followed by Surgery and Adjuvant BRAFMEK Inhibition in In-transit Melanoma Metastases NASAM
Status:
RECRUITING
Status Verified Date:
2023-03
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:
Phase 2 open-label single arm intervention study administering encorafenibbinimetinib in neo-adjuvant setting followed by surgery and subsequent adjuvant encorafenibbinimetinib in in-transit melanoma patients without lymph node and distant metastases
Detailed Description:
Phase 2 open-label single arm intervention study administering encorafenibbinimetinib in neo-adjuvant setting followed by surgery and subsequent adjuvant encorafenibbinimetinib in patients diagnosed solely with in-transit metastatic melanoma
Primary objective is to determine the efficacy of neo-adjuvant encorafenibbinimetinib as measured by pathological response rate partial- complete- and no response In the biopsy at week 0 the viability will be judged and will be graded according to the amount of tumor necrosis 50 tumor necrosis with 50 viable tumor cells 50 necrosis with 50 viable tumor cells and 100 necrosis without viable tumor cells Partial response is defined as a decrease of at least 50 of the viable tumor cells and complete response as 100 decrease of tumor cells whereas no response is defined as more than 50 of viable tumor cells present
Secondary objectives are to assess efficacy of adjuvant BRAFMEK inhibition measured as local recurrence free survival LRFS distant metastases-free survival DFMS recurrence free survival local andor distant recurrence RFS and overall survival OS Additionally the toxicity of the administered regimen will be assessed by analyzing the frequency- and type of adverse events and occurrences of therapy interruption dose reduction and or therapy cessation Moreover an exploration of drug measurements and ctDNA in blood and additional research of biopsies resections will be done
Primary objective is to determine the efficacy of neo-adjuvant encorafenibbinimetinib as measured by pathological response rate partial- complete- and no response In the biopsy at week 0 the viability will be judged and will be graded according to the amount of tumor necrosis 50 tumor necrosis with 50 viable tumor cells 50 necrosis with 50 viable tumor cells and 100 necrosis without viable tumor cells Partial response is defined as a decrease of at least 50 of the viable tumor cells and complete response as 100 decrease of tumor cells whereas no response is defined as more than 50 of viable tumor cells present
Secondary objectives are to assess efficacy of adjuvant BRAFMEK inhibition measured as local recurrence free survival LRFS distant metastases-free survival DFMS recurrence free survival local andor distant recurrence RFS and overall survival OS Additionally the toxicity of the administered regimen will be assessed by analyzing the frequency- and type of adverse events and occurrences of therapy interruption dose reduction and or therapy cessation Moreover an exploration of drug measurements and ctDNA in blood and additional research of biopsies resections will be done
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-002285-40 | EUDRACT_NUMBER | None | None |