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Kinase Inhibitor

Dabrafenib + Trametinib for Melanoma

Phase 2
Waitlist Available
Led By Alain P Algazi
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have BRAF V600E or BRAF V600K mutation identified by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory using acceptable analytic techniques
No other prior malignancy is allowed except for specified exceptions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing the effectiveness of two drugs, dabrafenib and trametinib, in treating patients with stage III-IV melanoma that contains a BRAF mutation.

Who is the study for?
This trial is for adults with stage III-IV melanoma that can't be surgically removed and have a specific BRAF mutation. They must take pills, have no serious gut issues, controlled brain metastases if present, meet blood criteria, not be pregnant/nursing, and agree to use contraception. Prior cancer treatments should be completed within specified time frames.Check my eligibility
What is being tested?
The study tests how well dabrafenib and trametinib treat advanced melanoma with a BRAF mutation when surgery isn't an option. These drugs block enzymes that tumor cells need to grow. The trial includes imaging tests like CT scans or PET/CT scans for monitoring.See study design
What are the potential side effects?
Dabrafenib and trametinib may cause side effects such as fever, fatigue, skin rash, high blood pressure, bleeding problems, eye problems (like blurred vision), heart issues (like fast heartbeat), liver problems (like yellowing of the skin), or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a BRAF V600E or V600K mutation, confirmed by a certified lab.
Select...
I have not had any other cancer types, with certain exceptions.
Select...
I can swallow pills and do not have stomach or intestine problems.
Select...
I am willing to have biopsies and blood tests for my skin or superficial cancer lesions.
Select...
I am 18 years old or older.
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My melanoma is at stage III or IV and has a specific BRAF mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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)
Secondary outcome measures
Overall survival
Rates of fever
Response rates
Other outcome measures
Change in biomarkers associated with PFS of archived tissue
Interaction between baseline biomarkers and treatment arm
Molecular events leading to reactivation of the MAPK pathway

Side effects data

From 2018 Phase 2 trial • 9 Patients • NCT02281760
100%
Chills
100%
Rash
100%
Hyperthermia
100%
Anaemia
83%
Dehydration
67%
Fatigue
67%
Blood urea increased
67%
Lipase increased
67%
Headache
50%
Nausea
50%
Blood creatinine increased
50%
Blood cholesterol increased
50%
Hyponatraemia
50%
Diarrhoea
50%
Back pain
50%
Pain in extremity
50%
Amylase increased
50%
Blood creatine phosphokinase increased
33%
Dyspepsia
33%
Aspartate aminotransferase increased
33%
Blood pressure increased
33%
Myalgia
33%
Red blood cells urine
33%
Alanine aminotransferase increased
33%
Hypotension
33%
Labile hypertension
33%
Hypertension
33%
Hypertriglyceridaemia
33%
Blood alkaline phosphatase increased
33%
Ataxia
33%
Abdominal pain
33%
Urinary tract infection
33%
Cough
33%
Malaise
33%
Vomiting
33%
Disturbance in attention
17%
Arthralgia
17%
Syncope
17%
Vertigo
17%
Arthritis
17%
Penile pain
17%
Gamma-glutamyltransferase increased
17%
Memory impairment
17%
Gingival recession
17%
Paronychia
17%
Viral infection
17%
Prothrombin time prolonged
17%
Leukopenia
17%
Erythema nodosum
17%
Hypernatraemia
17%
Sweating fever
17%
Hyperglycaemia
17%
Lip dry
17%
Lymphadenopathy
17%
Acute kidney injury
17%
Pharyngitis
17%
Urosepsis
17%
Nasal congestion
17%
Hypomagnesaemia
17%
Blood thyroid stimulating hormone decreased
17%
Cystatin C increased
17%
Anorexia nervosa
17%
Skin sensitisation
17%
Joint effusion
17%
Confusional state
17%
Proteinuria
17%
Dyspnoea
17%
Hyperuricaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Therapy With Dabrafenib and Trametinib in Patients With ECD

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (intermittent dosing)Experimental Treatment7 Interventions
Patients receive dabrafenib PO BID and trametinib PO QD on days 1-7 and 29-56 of each cycle. Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT or CT scans in week 1 of cycle 2 and at off treatment follow up prior to progression. Additionally, patients undergo blood sample collection, ECHO or MUGA on study.
Group II: Arm I (continuous dosing)Experimental Treatment7 Interventions
Patients receive dabrafenib PO BID and trametinib PO QD on days 1-56 of each cycle. Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT or CT scans in week 1 of cycle 2 and at off treatment follow up prior to progression. Additionally, patients undergo blood sample collection, ECHO or MUGA on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multigated Acquisition Scan
2015
Completed Phase 2
~50
Echocardiography
2013
Completed Phase 4
~11670
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Dabrafenib Mesylate
2014
Completed Phase 2
~10
Positron Emission Tomography
2008
Completed Phase 2
~2210
Trametinib Dimethyl Sulfoxide
2014
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,083 Total Patients Enrolled
559 Trials studying Melanoma
195,162 Patients Enrolled for Melanoma
Alain P AlgaziPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Dabrafenib Mesylate (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02196181 — Phase 2
Melanoma Research Study Groups: Arm I (continuous dosing), Arm II (intermittent dosing)
Melanoma Clinical Trial 2023: Dabrafenib Mesylate Highlights & Side Effects. Trial Name: NCT02196181 — Phase 2
Dabrafenib Mesylate (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02196181 — Phase 2
~14 spots leftby Dec 2024
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