Ignite Creation Date:
2024-05-06 @ 3:13 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02231775
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2014-09-02
Brief Title:
Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Neoadjuvant and Adjuvant Dabrafenib and Trametinib in Patients With Clinical Stage III Melanoma Combi-Neo
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:
This is a single arm phase II trial focused on how dabrafenib and trametinib before and after surgery works in treating patients with stage IIIB-C melanoma that has a specific mutation in the BRAF gene Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving dabrafenib and trametinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving dabrafenib and trametinib after surgery may kill any remaining tumor cells
Detailed Description:
PRIMARY OBJECTIVE
I To compare relapse-free survival RFS between patients who develop a pathologic complete response pCR or do not achieve a pCR following dabrafenib and trametinib neoadjuvant combination therapy in patients with locally advanced BRAF V600 mutated melanoma
SECONDARY OBJECTIVES
I To compare overall survival of patients with pathologic complete response pCR and patients without pCR who are receiving dabrafenib and trametinib neoadjuvant therapy followed by adjuvant combination therapy
II To identify biomarkers predictive of response through collection of serial blood draws and biopsies in patients receiving neoadjuvant dabrafenib and trametinib combination therapy
III To evaluate the safety of dabrafenib and trametinib in combination in this patient population
EXPLORATORY OBJECTIVE
I To evaluate and perform further advanced imaging analysis on magnetic resonance imaging MRI computed tomography CT and positron emission tomography PET scanned if available images collected on patients enrolled onto this study
OUTLINE
Patients receive dabrafenib orally PO twice daily BID and trametinib PO once daily QD for 8 weeks After completion of 8 weeks of dabrafenib and trametinib patients undergo surgery Approximately 1 week after surgery patients receive dabrafenib PO BID and trametinib PO QD for 44 additional weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year
I To compare relapse-free survival RFS between patients who develop a pathologic complete response pCR or do not achieve a pCR following dabrafenib and trametinib neoadjuvant combination therapy in patients with locally advanced BRAF V600 mutated melanoma
SECONDARY OBJECTIVES
I To compare overall survival of patients with pathologic complete response pCR and patients without pCR who are receiving dabrafenib and trametinib neoadjuvant therapy followed by adjuvant combination therapy
II To identify biomarkers predictive of response through collection of serial blood draws and biopsies in patients receiving neoadjuvant dabrafenib and trametinib combination therapy
III To evaluate the safety of dabrafenib and trametinib in combination in this patient population
EXPLORATORY OBJECTIVE
I To evaluate and perform further advanced imaging analysis on magnetic resonance imaging MRI computed tomography CT and positron emission tomography PET scanned if available images collected on patients enrolled onto this study
OUTLINE
Patients receive dabrafenib orally PO twice daily BID and trametinib PO once daily QD for 8 weeks After completion of 8 weeks of dabrafenib and trametinib patients undergo surgery Approximately 1 week after surgery patients receive dabrafenib PO BID and trametinib PO QD for 44 additional weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-0409 | OTHER | M D Anderson Cancer Center | None |
| NCI-2014-01969 | REGISTRY | None | None |