Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04221438
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-19
First Post:
2020-01-06
Brief Title:
Testing Treatment With Encorafenib and Binimetinib Before Surgery for Melanoma With Lymph Node Involvement
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Neoadjuvant Study of Encorafenib With Binimetinib in Patients With Resectable Locoregional Metastases From Cutaneous or Unknown Primary Melanoma Stages III N1BCD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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 phase II trial studies how well encorafenib and binimetinib work before surgery in treating patients with BRAF V600-mutated stage IIIB-D melanoma that has spread to the lymph nodes Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth This trial also studies how well 18F-FLT positron emission tomography PETcomputed tomography CT works in predicting the response of melanoma to encorafenib and binimetinib 18F-FLT is an imaging agent sometimes called a tracer PET and CT are types of imaging scans Using 18F-FLT PETCT together with encorafenib and binimetinib may provide more information on melanoma over time
Detailed Description:
PRIMARY CLINICAL OBJECTIVE
I To evaluate the pathologic complete response pCR rate of neoadjuvant treatment with encorafenib and binimetinib
SECONDARY CLINICAL OBJECTIVES
I To determine response rate RR Response Evaluation Criteria in Solid Tumors RECIST disease-free survival DFS and overall survival OS
II To describe correlation of pCR with RR DFS and OS III To assess safety and toxicity
CORRELATIVE SCIENCE OBJECTIVES
I To evaluate CD8 positive T cell infiltration and Ki-67 status in tumor or tumor bed pre during and post neoadjuvant treatment and the change in CD8 tumor infiltrating lymphocyte TIL with neoadjuvant treatment and correlate with clinical response
II To compare local review for pathologic response with central pathology review
III To assess the correlation between change in fluorothymidine F-18 18F-FLT PETCT uptake and change in Ki-67
IMAGING OBJECTIVES
I To compare the change in 18F-FLT PETCT uptake from baseline to post-neoadjuvant therapy among patients with and without pathologic complete response
II To compare post-neoadjuvant 18F-FLT PETCT uptake among patients with and without pathologic complete response
III To estimate an optimal threshold for prediction of pathologic complete response using i change in 18F-FLT PETCT uptake and ii post-neoadjuvant 18F-FLT PETCT uptake
IV To assess the correlation between change in 18F-FLT PETCT uptake and change in Ki-67
OUTLINE
NEOADJUVANT TREATMENT Patients receive 18F-FLT intravenously IV and undergo a PETCT scan approximately 60 minutes later Within 2 weeks patients receive encorafenib orally PO once daily QD and binimetinib PO twice daily BID on days 1-28 Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity Patients then receive 18F-FLT IV and undergo a second PETCT scan approximately 60 minutes later
SURGICAL RESECTION Within 2 weeks of completing therapy with encorafenib and binimetinib patients undergo surgery
ADJUVANT TREATMENT Within 2-7 days after surgery patients resume treatment with encorafenib PO QD and binimetinib PO BID on days 1-28 Treatment repeats every 28 days for up to 11 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year then every 6 months for 3 years
I To evaluate the pathologic complete response pCR rate of neoadjuvant treatment with encorafenib and binimetinib
SECONDARY CLINICAL OBJECTIVES
I To determine response rate RR Response Evaluation Criteria in Solid Tumors RECIST disease-free survival DFS and overall survival OS
II To describe correlation of pCR with RR DFS and OS III To assess safety and toxicity
CORRELATIVE SCIENCE OBJECTIVES
I To evaluate CD8 positive T cell infiltration and Ki-67 status in tumor or tumor bed pre during and post neoadjuvant treatment and the change in CD8 tumor infiltrating lymphocyte TIL with neoadjuvant treatment and correlate with clinical response
II To compare local review for pathologic response with central pathology review
III To assess the correlation between change in fluorothymidine F-18 18F-FLT PETCT uptake and change in Ki-67
IMAGING OBJECTIVES
I To compare the change in 18F-FLT PETCT uptake from baseline to post-neoadjuvant therapy among patients with and without pathologic complete response
II To compare post-neoadjuvant 18F-FLT PETCT uptake among patients with and without pathologic complete response
III To estimate an optimal threshold for prediction of pathologic complete response using i change in 18F-FLT PETCT uptake and ii post-neoadjuvant 18F-FLT PETCT uptake
IV To assess the correlation between change in 18F-FLT PETCT uptake and change in Ki-67
OUTLINE
NEOADJUVANT TREATMENT Patients receive 18F-FLT intravenously IV and undergo a PETCT scan approximately 60 minutes later Within 2 weeks patients receive encorafenib orally PO once daily QD and binimetinib PO twice daily BID on days 1-28 Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity Patients then receive 18F-FLT IV and undergo a second PETCT scan approximately 60 minutes later
SURGICAL RESECTION Within 2 weeks of completing therapy with encorafenib and binimetinib patients undergo surgery
ADJUVANT TREATMENT Within 2-7 days after surgery patients resume treatment with encorafenib PO QD and binimetinib PO BID on days 1-28 Treatment repeats every 28 days for up to 11 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year then every 6 months for 3 years
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 |
|---|---|---|---|
| NCI-2019-07407 | REGISTRY | None | None |
| EA6183 | OTHER | None | None |
| EA6183 | OTHER | None | None |
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |