← Back to Search

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

Select...

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.

Select...

My melanoma is at stage III or IV and has a specific BRAF mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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%

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 Treatment4 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.

Group II: Arm I (continuous dosing)Experimental Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Dabrafenib Mesylate

2014

Completed Phase 2

~10

Positron Emission Tomography

2008

Completed Phase 2

~2240

Trametinib Dimethyl Sulfoxide

2014

Completed Phase 2

~10

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,873 Total Patients Enrolled

557 Trials studying Melanoma

192,953 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

Frequently Asked Questions

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

What is the cap for participants in this experiment?

"Unfortunately, this research has stopped enrolling participants. It was first posted on July 22nd 2014 and last edited November 8th 2022. If you are researching other options, there are currently 816 studies looking to include cutaneous melanoma patients and 95 trials recruiting individuals taking dabrafenib mesylate."

Answered by AI

Are there any additional studies that have utilized Dabrafenib Mesylate?

"First studied in 2012 at the University of Chicago Medical Center, dabrafenib mesylate has since seen 138 clinical trials to completion. Currently, 95 live trials are underway - a large portion of which based in Toledo and Tennessee."

Answered by AI

Has Dabrafenib Mesylate been granted the green light by governmental regulatory agencies?

"The preliminary clinical data for Dabrafenib Mesylate suggests it is a safe medication and has been given a score of 2. However, as this evaluation process was based on Phase 2 trial results, there is no evidence yet to support its efficacy."

Answered by AI

Are researchers currently taking in new participants for this clinical trial?

"Unfortunately, this particular trial is not open to new participants. It was originally posted on July 22nd 2014 and last modified November 8th 2022. However, there are currently 816 clinical trials for cutaneous melanoma and 95 studies specifically related to Dabrafenib Mesylate that are actively accepting patients."

Answered by AI

How many research centers are administering this investigation?

"100 trial locations exist, including Toledo Clinic Cancer Centers-Toledo in Toledo, Ballad Health Cancer Care - Kingsport in Kingsport and Ocean Medical Center in Brick."

Answered by AI

Recent research and studies

Nature MedicineJournal

Continuous Versus Intermittent BRAF and MEK Inhibition in Patients with Braf-mutated Melanoma: A Randomized Phase 2 Trial

Algazi, Alain P., Megan Othus, Adil I. Daud, Roger S. Lo, Janice M. Mehnert, Thach-Giao Truong, Robert Conry, et al.. 2020. “Continuous Versus Intermittent BRAF and MEK Inhibition in Patients with Braf-mutated Melanoma: A Randomized Phase 2 Trial”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-020-1060-8.

Cancer CellJournal

Anti-pd-1/l1 Lead-in Before MAPK Inhibitor Combination Maximizes Antitumor Immunity and Efficacy

Wang, Yujue, Sixue Liu, Zhentao Yang, Alain P. Algazi, Shirley H. Lomeli, Yan Wang, Megan Othus, et al.. 2021. “Anti-pd-1/l1 Lead-in Before MAPK Inhibitor Combination Maximizes Antitumor Immunity and Efficacy”. Cancer Cell. Elsevier BV. doi:10.1016/j.ccell.2021.07.023.

clinicaltrials.govStudy

Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAF Mutant Melanoma That Cannot Be Removed by Surgery

2014. "Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAF Mutant Melanoma That Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02196181.

All > Skin Cancer