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MAPK Pathway Inhibitor

MAPK Inhibitors + Pembrolizumab for Melanoma

Phase 2
Waitlist Available
Led By Ryan J Sullivan, 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
Age greater than or equal to 18 years.
Participants must have normal organ and marrow function as defined below:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing the combination of these drugs to see if it is more effective in treating unresectable or metastatic melanoma than pembrolizumab alone.

Who is the study for?
Adults with confirmed metastatic or unresectable melanoma, measurable disease, known BRAFV600 mutation status, and willing to undergo biopsies can join. They may have had certain prior treatments but not specific recent therapies or surgeries. Those with major organ function issues, active infections like HIV/Hepatitis B/C, autoimmune diseases requiring treatment in the past 2 years, a history of certain lung conditions, live vaccines within 30 days before the trial start date, pregnancy or other serious illnesses are excluded.Check my eligibility
What is being tested?
The study is testing a combination of Pembrolizumab (Keytruda), Trametinib (Mekinist), and Dabrafenib (Tafinlar) as potential treatments for advanced melanoma. The goal is to see if this drug mix can help control the disease better than current standard options.See study design
What are the potential side effects?
Possible side effects include immune system reactions that might affect organs; skin rash; liver enzyme changes; fever; fatigue; nausea and diarrhea from Trametinib/Dabrafenib; and infusion-related reactions from Pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My organ and bone marrow functions are normal.
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I am willing to have multiple biopsies of my tumor.
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I have previously been treated with ipilimumab, anti-PD1, or high-dose IL-2.
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My melanoma cannot be removed by surgery and has spread.
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I have a tumor that can be measured with a scan.
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I know my cancer's BRAFV600 mutation status.
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I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Rate of Clinical Benefit
Secondary outcome measures
Overall Survival at 1 Year
Progression Free Survival (PFS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: BRAFV600 wild typeExperimental Treatment2 Interventions
Pembrolizumab administered intravenously every three weeks Trametinib taken every twelve hours orally
Group II: BRAFV600 mutantExperimental Treatment3 Interventions
Pembrolizumab administered intravenously every three weeks Dabrafenib taken every twelve hours orally Trametinib taken every twelve hours orally
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Dabrafenib
2011
Completed Phase 3
~4120
Trametinib
2014
Completed Phase 2
~1600

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,819 Total Patients Enrolled
22 Trials studying Melanoma
1,083 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,684 Total Patients Enrolled
120 Trials studying Melanoma
21,626 Patients Enrolled for Melanoma
Ryan J Sullivan, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
106 Total Patients Enrolled
2 Trials studying Melanoma
106 Patients Enrolled for Melanoma

Media Library

Dabrafenib (MAPK Pathway Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03149029 — Phase 2
Melanoma Research Study Groups: BRAFV600 mutant, BRAFV600 wild type
Melanoma Clinical Trial 2023: Dabrafenib Highlights & Side Effects. Trial Name: NCT03149029 — Phase 2
Dabrafenib (MAPK Pathway Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03149029 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you detail the other research initiatives related to Pembrolizumab?

"At present, there are 1,045 trials for Pembrolizumab live on a global scale. Out of these studies, 128 are in the third phase and Rochester, Minnesota houses many of them. Additionally, 41,395 locations have been identified as running clinical studies with this drug."

Answered by AI

What is the upper boundary for participant numbers in this clinical experiment?

"This clinical trial has since ended its recruitment process, with the initial post being published on November 27th 2017 and last updated August 30th 2022. For those looking for other studies to join, there are 765 trials searching for patients dealing with melanoma and 1,045 trials actively recruiting participants interested in Pembrolizumab."

Answered by AI

Does the research team have open enrollment for participants?

"Currently, no more participants are being sought for this trial. Initially posted on November 27th 2017 and most recently edited August 30th 2022, the study is now closed. However, there remain 765 clinical trials that recruit patients with melanoma and 1045 studies recruiting those eligible to receive Pembrolizumab treatment."

Answered by AI

Are there any adverse effects to utilizing Pembrolizumab?

"Our assessment of Pembrolizumab's safety is a 2 as it is currently undergoing Phase 2 trials, which indicate the presence of some data on its safety but not yet any evidence concerning its efficacy."

Answered by AI

What maladies is Pembrolizumab regularly employed to ameliorate?

"Pembrolizumab is the primary drug of choice for treating malignant neoplasms. This medication can also be effective at managing unresectable melanoma, microsatellite instability high, and chemotherapy-induced illness progression."

Answered by AI
~2 spots leftby Mar 2025