MAPK Inhibitors + Pembrolizumab for Melanoma

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: BRAF inhibitors, MEK inhibitors

Disqualifiers: Symptomatic brain metastases, Active autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying a combination of drugs as a possible treatment for unresectable or metastatic melanoma. The drugs involved in this study are: * Pembrolizumab (Keytruda) * Trametinib (Mekinist) * Dabrafenib (Tafinlar)

Research Team

Ryan J Sullivan, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion Criteria

My organ and bone marrow functions are normal.

I have previously been treated with ipilimumab, anti-PD1, or high-dose IL-2.

I am willing to have multiple biopsies of my tumor.

Exclusion Criteria

I haven't had chemotherapy or radiation in the last 2 weeks and have recovered from any side effects.

I have a history of retinal vein blockage or detachment.

You are allergic to pembrolizumab or any of its ingredients.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab intravenously every three weeks, with dabrafenib and trametinib taken orally every twelve hours for BRAFV600 mutant, or trametinib alone for BRAFV600 wild type

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments for clinical benefit at 6 months

6 months

Long-term Follow-up

Overall survival and progression-free survival are assessed up to 62 months

Up to 62 months

Treatment Details

Interventions

• Dabrafenib
• Pembrolizumab
• Trametinib

Trial Overview 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.

Participant Groups

Group I: BRAFV600 wild type Experimental Treatment 2 Interventions

* Pembrolizumab administered intravenously every three weeks * Trametinib taken every twelve hours orally

Group II: BRAFV600 mutant Experimental Treatment 3 Interventions

* Pembrolizumab administered intravenously every three weeks * Dabrafenib taken every twelve hours orally * Trametinib taken every twelve hours orally

Dabrafenib is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Tafinlar for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation
• Adjuvant treatment of melanoma with a BRAF V600 mutation

Approved in United States as Tafinlar for:

• Unresectable or metastatic melanoma with a BRAF V600E mutation
• Adjuvant treatment of melanoma with a BRAF V600E or V600K mutation
• Metastatic non-small cell lung cancer with a BRAF V600E mutation

Approved in Canada as Tafinlar for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation
• Adjuvant treatment of melanoma with a BRAF V600 mutation

Approved in Japan as Tafinlar for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University