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Kinase Inhibitor

Dabrafenib + Trametinib +/- Hydroxychloroquine for Melanoma

Phase 2
Waitlist Available
Led By Ravi Amaravadi
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have locally advanced unresectable stage IIIC or stage IV melanoma
Patient must have been treated with prior immune checkpoint inhibitor therapy (anti PD-1 antibody, anti-CTLA-4 antibody or a combination regimen including either or both agents) either in the adjuvant or metastatic setting. Patient may have received investigational agents in combination with standard therapy, as long as it was adhering to the timeframes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to progression or death (whichever occurs first), assessed at 1 year after completion of treatment
Awards & highlights

Study Summary

This trial is testing adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib to see if it is more effective in treating patients with stage IIIC or IV BRAF V600E/K melanoma.

Who is the study for?
This trial is for adults with advanced melanoma (stage IIIC or IV) that has a specific mutation (BRAF V600E/K). Participants must have previously tried immunotherapy, be able to take oral medication, and not be pregnant or breastfeeding. They should not have other serious medical conditions or infections, and cannot join if they've had certain heart issues or are on drugs that could interact poorly with the study medications.Check my eligibility
What is being tested?
The study tests whether adding hydroxychloroquine to standard treatment with dabrafenib and trametinib helps overcome resistance in melanoma. Patients will either receive this combination or just dabrafenib and trametinib without hydroxychloroquine to see which works better at controlling cancer growth.See study design
What are the potential side effects?
Possible side effects include digestive issues, vision changes, liver enzyme changes, skin reactions, heart problems like irregular heartbeat or low ejection fraction, muscle pain, fatigue, and increased risk of infection due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma is at an advanced stage and cannot be surgically removed.
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I have been treated with immune therapy for my cancer.
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I have another cancer type, but it won't affect this trial's treatment.
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My tumor has the BRAF V600E or V600K mutation.
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My cancer can be measured and was checked within the last 3 weeks.
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I've had BRAF and MEK inhibitors as part of my past treatment, stopped over 6 months ago, and didn't quit due to side effects.
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I stopped my immunotherapy or chemotherapy more than 4 weeks ago.
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I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.
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My hepatitis B virus load is undetectable with treatment.
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I have treated brain metastases, no recent gamma knife therapy, and no unstable spinal issues.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I can understand and am willing to sign the consent form, or I have someone who can do it for me.
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I am fully active or can carry out light work.
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I have brain metastases but don't need immediate treatment for them.
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I am using or willing to use effective birth control or abstain from sex during the study and for 4 months after.
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I stopped taking any targeted cancer pills at least 2 weeks ago.
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I can take pills and don't have major stomach or bowel issues affecting drug absorption.
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I have had chemotherapy or radiation therapy before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to progression or death (whichever occurs first), assessed at 1 year after completion of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to progression or death (whichever occurs first), assessed at 1 year after completion of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS) rate
Secondary outcome measures
Complete response rate
Incidence of adverse events
Overall response rate
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (dabrafenib, trametinib, hydroxychloroquine)Experimental Treatment3 Interventions
Patients receive dabrafenib mesylate PO BID, trametinib dimethyl sulfoxide PO QD, and hydroxychloroquine sulfate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (dabrafenib, trametinib, placebo)Active Control3 Interventions
Patients receive dabrafenib mesylate PO BID, trametinib dimethyl sulfoxide PO QD, and placebo PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib Dimethyl Sulfoxide
2014
Completed Phase 2
~10
Hydroxychloroquine Sulfate
2015
Completed Phase 4
~1080
Dabrafenib Mesylate
2014
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
115 Previous Clinical Trials
176,738 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,562 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Ravi AmaravadiPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Dabrafenib Mesylate (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04527549 — Phase 2
Cutaneous Melanoma Research Study Groups: Arm B (dabrafenib, trametinib, placebo), Arm A (dabrafenib, trametinib, hydroxychloroquine)
Cutaneous Melanoma Clinical Trial 2023: Dabrafenib Mesylate Highlights & Side Effects. Trial Name: NCT04527549 — Phase 2
Dabrafenib Mesylate (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04527549 — Phase 2

Frequently Asked Questions

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

Is this research endeavor currently open to enrollees?

"At the present time, this trial is not enrolling new participants. Initially posted on October 23rd 2020, it was last revised on October 12th 2022. Melanoma patients have 816 available clinical trials and those interested in Hydroxychloroquine Sulfate can select from 155 active studies."

Answered by AI

What potential risks come with utilizing Hydroxychloroquine Sulfate?

"Hydroxychloroquine Sulfate was deemed moderately safe with a score of 2, as it is currently in Phase 2 clinical trials where some data has been collected to support its safety profile but none for efficacy."

Answered by AI

What is the geographical distribution of this trial?

"This research has launched out of Broadlawns Medical Center in Des Moines, Iowa, Greater Regional Medical Center in Creston, Florida and UM Sylvester Comprehensive Cancer Center at Aventura in Aventura Ohio. It is also taking place across an additional 100 sites."

Answered by AI

To what illnesses is Hydroxychloroquine Sulfate typically administered?

"Hydroxychloroquine Sulfate is a viable therapeutic option for metastatic melanoma, unresectable melanoma and malaria."

Answered by AI

Has Hydroxychloroquine Sulfate been examined in any prior investigations?

"The University of Nebraska Medical Center first began researching Hydroxychloroquine Sulfate in 2007, with 232 studies completed since then. Currently 155 trials are being conducted around the world; Des Moines, Iowa is a major hub for these investigations."

Answered by AI

What is the cap on the enrollment of participants for this research?

"Currently, this clinical trial is not accepting new patients. Initially posted on October 23rd 2020, the study was most recently updated on October 12th 2022. For those looking for alternative trials, 816 studies are actively recruiting participants with melanoma while 155 are taking in volunteers to test Hydroxychloroquine Sulfate's efficacy."

Answered by AI
~32 spots leftby Nov 2025