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Kinase Inhibitor
Trametinib for Melanoma
Phase 1
Waitlist Available
Led By Keith T. Flaherty, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 7 months
Awards & highlights
Study Summary
This trial is studying how well the combination of itacitinib, dabrafenib, and trametinib works in treating patients with BRAF-mutant melanoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose
Secondary outcome measures
Number of Participants With Progression-Free Survival at 6 Months
Objective Response Rate
Overall Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Trametinib + Dabrafenib + INCB039110Experimental Treatment3 Interventions
Dabrafenib is administered orally every 12 hours
Trametinib is administered orally once a day
INCB039110 is administered orally once a day
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
Find a Location
Who is running the clinical trial?
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,164 Total Patients Enrolled
11 Trials studying Melanoma
2,101 Patients Enrolled for Melanoma
Massachusetts General HospitalLead Sponsor
2,932 Previous Clinical Trials
13,198,494 Total Patients Enrolled
22 Trials studying Melanoma
1,098 Patients Enrolled for Melanoma
Keith T. Flaherty, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been treated with other cancer drugs before. Any side effects from these drugs must be mild (Grade 1 or less) according to a standard classification system. Hair loss and mild nerve damage (Grade 2 or less) are not included.You should be able to perform daily activities without much difficulty, with a Karnofsky score of 70% or higher.You have a confirmed diagnosis of a certain type of cancer with a specific genetic mutation (BRAF V600E/K). Your cancer has spread or cannot be removed by surgery, and you have already received and tolerated BRAF-targeted therapy or have not received it before. Other treatments have not worked or are not available.You have a specific type of melanoma with a genetic mutation called BRAF (V600E/K). It must be confirmed by a laboratory test. The melanoma has spread or cannot be surgically removed. You have previously been treated with a medication that targets BRAF or a combination of BRAF and another drug called MEK, and you either responded well to the treatment or didn't have any negative reactions.You need to be at least 18 years old to participate in this study.Your doctor thinks you will live for at least 3 more months.You are expected to live for at least 3 more months.You are pregnant or breastfeeding.You are taking medicine that is not allowed in this study.You are currently taking part in another study involving experimental drugs.You have taken JAK1 inhibitor medication before.You have a medical condition that is not being treated or controlled.You have had a lung disease called interstitial lung disease or pneumonitis in the past.You have a history of heart problems or are at risk for heart problems.If a non-FDA approved method was used for testing, the Overall Principal Investigator must approve the information about the test.You have at least one measurable tumor that can be accurately measured by a doctor using a ruler or imaging technology like CT scan or MRI. The tumor must be at least 20mm in its longest dimension or 10mm if measured with advanced imaging techniques.Your white blood cell count is at least 3,000 cells per microliter.You have enough white blood cells called neutrophils.You have had another type of cancer in the past 5 years, except in certain cases.
Research Study Groups:
This trial has the following groups:- Group 1: Trametinib + Dabrafenib + INCB039110
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.
Can Dabrafenib be sanctioned by the FDA?
"Due to the limited data regarding safety and efficacy, our experts at Power have rated Dabrafenib’s security a 1 on a scale of 1 to 3."
Answered by AI
What prior research has been conducted involving Dabrafenib?
"Presently, 117 research projects are ongoing for Dabrafenib with 7 of them being in the third phase. Although Honolulu, Hawaii is where most investigations take place, 6201 sites offer trials concerning this medication."
Answered by AI
How many participants are being selected for this trial?
"This medical experiment is no longer enrolling patients. Initially posted on May 29th, 2019 and last updated November 1st 2021, those seeking to join a clinical trial should consider the 753 trials for melanoma or 117 studies incorporating Dabrafenib that are still actively recruiting participants."
Answered by AI
Are there any openings for prospective participants to join this research project?
"This clinical trial, which was posted in May 2019 and last modified on November 1st 2021, is no longer seeking participants. However, 870 other studies are currently open to potential candidates."
Answered by AI
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