Ignite Creation Date:
2024-05-06 @ 1:12 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01754376
Status:
TERMINATED
Last Update Posted:
2017-04-12
First Post:
2012-12-16
Brief Title:
Combined BRAF-Targeted Therapy Immunotherapy for Melanoma
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
COMBAT 1 A Phase II Trial of Combined BRAF-Targeted Therapy and Immunotherapy for Melanoma
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
changes in available treatments for melanoma
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is a Phase II clinical trial of an investigational combination of drugs vemurafenib and aldesleukin to learn whether the combination works in treating a specific cancer While both vemurafenib and aldesleukin are approved by the FDA for the treatment of metastatic melanoma the FDA has not yet approved the combination of vemurafenib and aldesleukin
Researchers have found that a large number of melanoma cells have mutations in the BRAF gene It has been shown that vemurafenib blocks the effects of these mutations in the BRAF gene and as a result may help to prevent cancer growth
Aldesleukin also referred to as IL-2 is an immunotherapy drug administered via IV infusion that increases the growth of key cells within the immune system that are responsible for targeting cancer cells Activating more of these key cells called T-lymphocytes and natural-killer cells leads to increased cancer cell death
The BRAF gene is located on a larger pathway called the MAPK pathway Studies have shown that when a BRAF inhibitor like vemurafenib is used to block the MAPK pathway melanocytes or cancer cells express more proteins on their surfaces making them easier for T-lymphocytes and natural killer cells to recognize and kill them This suggests that combining BRAF-targeted therapy with aldesleukin which activates more of these white blood cells can lead to an increase in the death of cancer cells
In this research study the investigators are looking to see whether the combination of vemurafenib a BRAF-inhibitor combined with aldesleukinan immunotherapy drug work together to produce a better health outcome in people with metastatic melanoma
Researchers have found that a large number of melanoma cells have mutations in the BRAF gene It has been shown that vemurafenib blocks the effects of these mutations in the BRAF gene and as a result may help to prevent cancer growth
Aldesleukin also referred to as IL-2 is an immunotherapy drug administered via IV infusion that increases the growth of key cells within the immune system that are responsible for targeting cancer cells Activating more of these key cells called T-lymphocytes and natural-killer cells leads to increased cancer cell death
The BRAF gene is located on a larger pathway called the MAPK pathway Studies have shown that when a BRAF inhibitor like vemurafenib is used to block the MAPK pathway melanocytes or cancer cells express more proteins on their surfaces making them easier for T-lymphocytes and natural killer cells to recognize and kill them This suggests that combining BRAF-targeted therapy with aldesleukin which activates more of these white blood cells can lead to an increase in the death of cancer cells
In this research study the investigators are looking to see whether the combination of vemurafenib a BRAF-inhibitor combined with aldesleukinan immunotherapy drug work together to produce a better health outcome in people with metastatic melanoma
Detailed Description:
Subjects will take oral vemurafenib twice a day for 2 weeks Following this lead-in period subjects will receive aldesleukin via IV infusion on Day 15 of the study One course of aldesleukin is 12 weeks long subjects will receive aldesleukin via IV infusion every 8 hours for the first five days Subjects will be hospitalized for the 5 days that they are receiving aldesleukin
Week 1 of aldesleukin will be days 15-19 M-F of the 12 week cycle Following Week 1 of therapy subjects will be discharged from the hospital and only take vemurafenib at home for the following week Subjects will then come in for one more week of aldesleukin during days 29-33 of the 12 week cycle This is referred to as Week 2 of aldesleukin
Subjects will continue to take vemurafenib twice daily during the course of aldesleukin Their cancer will be evaluated at screening and at Week 12 following the beginning of the first aldesleukin course with a CT scan After the first cycle tumors will be evaluated every 8 weeks for the first year then every 12 weeks for years 2 and 3 every 6 months for year 5 and annually thereafter
If scans show that the subjects cancer has improved after the first course of aldesleukin subjects may be allowed to continue on to a second course In the event of a second course of aldesleukin subjects will remain on vemurafenib throughout the second course
Week 1 of aldesleukin will be days 15-19 M-F of the 12 week cycle Following Week 1 of therapy subjects will be discharged from the hospital and only take vemurafenib at home for the following week Subjects will then come in for one more week of aldesleukin during days 29-33 of the 12 week cycle This is referred to as Week 2 of aldesleukin
Subjects will continue to take vemurafenib twice daily during the course of aldesleukin Their cancer will be evaluated at screening and at Week 12 following the beginning of the first aldesleukin course with a CT scan After the first cycle tumors will be evaluated every 8 weeks for the first year then every 12 weeks for years 2 and 3 every 6 months for year 5 and annually thereafter
If scans show that the subjects cancer has improved after the first course of aldesleukin subjects may be allowed to continue on to a second course In the event of a second course of aldesleukin subjects will remain on vemurafenib throughout the second course
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