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Kinase Inhibitor
Dabrafenib + Trametinib Before and After Surgery for Melanoma
Phase 2
Waitlist Available
Led By Rodabe N Amaria
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BRAF mutation-positive melanoma (V600E or V600K) based on report from a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing whether giving dabrafenib and trametinib before and after surgery is effective in treating stage IIIB-C melanoma with a BRAF gene mutation.
Who is the study for?
This trial is for patients with stage IIIB-C melanoma that can be removed by surgery and have a BRAF V600 mutation. Participants must be fit for surgery, not on current cancer treatments, able to consent, and meet specific health criteria including blood counts. Women of childbearing potential and men must agree to use contraception.Check my eligibility
What is being tested?
The study tests the effects of dabrafenib and trametinib before and after surgery in shrinking tumors and eliminating remaining cancer cells. It's a phase II trial where all participants receive both drugs; there are no comparison groups.See study design
What are the potential side effects?
Dabrafenib and trametinib may cause side effects like fever, fatigue, skin rash, high blood pressure, bleeding problems, heart issues, eye problems, liver dysfunction or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma has a BRAF mutation (V600E or V600K).
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I am fully active or can carry out light work.
Select...
My melanoma is stage IIIB/C and can be completely removed by surgery without affecting major vessels, nerves, or bones.
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I agree to use birth control methods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relapse-free survival (RFS)
Secondary outcome measures
Complete pathologic response
Incidence of adverse events
Markers predictive of response collected by serial blood draws and biopsies
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (dabrafenib, trametinib, surgery)Experimental Treatment4 Interventions
Patients receive dabrafenib PO BID and trametinib PO 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1550
Dabrafenib
2011
Completed Phase 3
~4120
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,095 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,723 Total Patients Enrolled
2 Trials studying Cutaneous Melanoma
5,053 Patients Enrolled for Cutaneous Melanoma
Rodabe N AmariaPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Cutaneous Melanoma
53 Patients Enrolled for Cutaneous Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have stomach or intestine problems that affect how drugs work in my body.I have not taken any cancer treatment or experimental drugs in the last 28 days.The surgical team has approved me as fit for surgery.I have a G6PD deficiency.I have had major surgery recently.My melanoma has a BRAF mutation (V600E or V600K).I am fully active or can carry out light work.My melanoma is stage IIIB/C and can be completely removed by surgery without affecting major vessels, nerves, or bones.Your blood test results need to meet certain standards.I am not taking any medication that is not allowed in the study.My heart condition and rhythm are stable.I am following the required birth control guidelines due to my potential to conceive.My diabetes or blood pressure is not well-controlled.I agree to use birth control methods.Patients must have a measurable tumor according to specific guidelines.The local pathologist and team will confirm the diagnosis and decide if the tumor can be surgically removed.My cancer has spread to my brain or bones.I have previously received BRAF or MEK inhibitors.I have had cancer before.I have a history of specific eye problems.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (dabrafenib, trametinib, surgery)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment rate of this medical trial?
"This research is no longer recruiting patients. Initially published on October 22nd, 2014 and most recently updated on October 6th 2022, this clinical trial has come to a close. Nevertheless, 816 studies are still accepting participants with skin cancer and 95 trials for Dabrafenib remain open for enrollment."
Answered by AI
Has Dabrafenib received authorization from the Food and Drug Administration?
"Dabrafenib's safety is suspected to be of a moderate level based on the data available from Phase 2 trials, and this was assigned a rating of two. Unfortunately, no evidence exists as yet for efficacy."
Answered by AI
What additional research has been conducted on the efficacy of Dabrafenib?
"Currently, 95 clinical trials are in progress exploring the potential of Dabrafenib; 6 of these reside in Phase 3. Although most research is conducted on Honolulu, Hawaii, a total 5805 locations around the world are conducting studies concerning this medication."
Answered by AI
Is participation in this experiment open to potential participants right now?
"Currently, this trial is not accepting patients. This research was first posted on October 22nd 2014 and its last revision occurred on October 6th 2022. For those seeking other studies related to skin cancer, 816 trials are actively enrolling while 95 of them involve Dabrafenib as an intervention."
Answered by AI
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