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Kinase Inhibitor

Dabrafenib + Trametinib Before and After Surgery for Melanoma

Phase 2

Waitlist Available

Led By Rodabe N Amaria

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BRAF mutation-positive melanoma (V600E or V600K) based on report from a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Must not have

Presence of active gastrointestinal disease or other condition that will interfere significantly with drug metabolism

Subjects with known glucose 6 phosphate dehydrogenase (G6PD) deficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether giving dabrafenib and trametinib before and after surgery is effective in treating stage IIIB-C melanoma with a BRAF gene mutation.

Who is the study for?

This trial is for patients with stage IIIB-C melanoma that can be removed by surgery and have a BRAF V600 mutation. Participants must be fit for surgery, not on current cancer treatments, able to consent, and meet specific health criteria including blood counts. Women of childbearing potential and men must agree to use contraception.

What is being tested?

The study tests the effects of dabrafenib and trametinib before and after surgery in shrinking tumors and eliminating remaining cancer cells. It's a phase II trial where all participants receive both drugs; there are no comparison groups.

What are the potential side effects?

Dabrafenib and trametinib may cause side effects like fever, fatigue, skin rash, high blood pressure, bleeding problems, heart issues, eye problems, liver dysfunction or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My melanoma has a BRAF mutation (V600E or V600K).

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I am fully active or can carry out light work.

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My melanoma is stage IIIB/C and can be completely removed by surgery without affecting major vessels, nerves, or bones.

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I agree to use birth control methods.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have stomach or intestine problems that affect how drugs work in my body.

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I have a G6PD deficiency.

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I am not taking any medication that is not allowed in the study.

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My heart condition and rhythm are stable.

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My cancer has spread to my brain or bones.

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I have previously received BRAF or MEK inhibitors.

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I have had cancer before.

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I have a history of specific eye problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relapse-free survival (RFS)

Secondary study objectives

Complete pathologic response

Incidence of adverse events

Markers predictive of response collected by serial blood draws and biopsies

+1 more

Side effects data

From 2021 Phase 3 trial • 552 Patients • NCT03551626

68%

Pyrexia

32%

Headache

30%

Blood creatine phosphokinase increased

27%

Diarrhoea

26%

Fatigue

26%

Chills

24%

Asthenia

23%

Nausea

21%

Arthralgia

21%

Rash

15%

Vomiting

15%

Myalgia

14%

Alanine aminotransferase increased

14%

Cough

13%

Lipase increased

13%

Aspartate aminotransferase increased

12%

Influenza like illness

12%

Oedema peripheral

Pain in extremity

Neutropenia

Abdominal pain

Constipation

Muscle spasms

Back pain

Blood alkaline phosphatase increased

Decreased appetite

Hypophosphataemia

Dyspnoea

Erythema

Hypertension

Amylase increased

Hyperglycaemia

Dry skin

Dizziness

Abdominal pain upper

Pain

Pruritus

Oropharyngeal pain

Ejection fraction decreased

Atrial fibrillation

Erysipelas

Cellulitis

Basal cell carcinoma

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

Dabrafenib+Trametinib (On-treatment)

Dabrafenib+Trametinib (Post-treatment Follow-up)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (dabrafenib, trametinib, surgery)Experimental Treatment4 Interventions

Patients receive dabrafenib PO BID and trametinib PO QD for 8 weeks. After completion of 8 weeks of dabrafenib and trametinib, patients undergo surgery. Approximately 1 week after surgery, patients receive dabrafenib PO BID and trametinib PO QD for 44 additional weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib

2014

Completed Phase 2

~1630

Dabrafenib

2011

Completed Phase 3

~4120