Ignite Creation Date:
2024-05-06 @ 2:25 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02036086
Status:
UNKNOWN
Last Update Posted:
2022-10-27
First Post:
2013-11-28
Brief Title:
Study of Neo-adjuvant Use of Vemurafenib Plus Cobimetinib for BRAF Mutant Melanoma With Palpable Lymph Node Metastases
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
A Pilot Study of the Neo-adjuvant Use of Vemurafenib Plus Cobimetinib GDC-0973 in Patients With BRAF Mutant Melanoma With Palpable Lymph Node Metastases
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study will evaluate the clinical and pathological response to vemurafenib and cobimetinib in the neoadjuvant treatment of patients with histologically confirmed BRAF V600 mutation-positive Stage IIIB and C melanoma 20 patients will be treated with vemurafenib and cobimetinib for 2 months Then they will be assessed for surgery Patients will undergo surgery and subsequently resume taking vemurafenib and cobimetinib after recovery from surgery Patients will undergo radiation therapy if appropriate then continue vemurafenib and cobimetinib The maximum treatment period is 12 months After 12 months of treatment patients will be followed for disease recurrence and survival during for a total of 5 years
Detailed Description:
At Screening Assessments will include CT or MRI of the brain CT of chest abdomen and pelvis dermatology assessment head and neck exam pelvic and anal exam ophthalmology exam electrocardiogram ECG echocardiogram ECHO or multigated acquisition MUGA scan a history and physical exam A core biopsy will be performed within 14 days of study entry
During Treatment The maximum treatment period is 12 months Patients will be assessed monthly while on treatment Assessments performed will include vital signs assessment and physical exam dermatology exam ophthalmology exam echocardiogram ECHO or multigated acquisition MUGA scan electrocardiogram ECG safety blood tests pelvic and anal exam
Follow-up after treatment Patients will be followed for 5 years Radiology exams will be done to assess for disease Other assessments performed include vital signs assessment and physical exam dermatology exam include echogram ECHO or multigated acquisition MUGA scans
During Treatment The maximum treatment period is 12 months Patients will be assessed monthly while on treatment Assessments performed will include vital signs assessment and physical exam dermatology exam ophthalmology exam echocardiogram ECHO or multigated acquisition MUGA scan electrocardiogram ECG safety blood tests pelvic and anal exam
Follow-up after treatment Patients will be followed for 5 years Radiology exams will be done to assess for disease Other assessments performed include vital signs assessment and physical exam dermatology exam include echogram ECHO or multigated acquisition MUGA scans
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