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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

Must not have

Patients must not have received any anti-cancer drug within 28 days prior to registration, and must not have received any nitrosoureas or mitomycin C within 42 days prior to registration

Patients with known history or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR) are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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I have not had any other cancer types, with certain exceptions.

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I can swallow pills and do not have stomach or intestine problems.

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I am willing to have biopsies and blood tests for my skin or superficial cancer lesions.

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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.

Exclusion Criteria

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

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I haven't taken any cancer drugs in the last 28 days, nor nitrosoureas or mitomycin C in the last 42 days.

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I do not have a history of or current retinal vein occlusion or central serous retinopathy.

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I do not have serious heart conditions or recent heart attacks.

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I do not have hepatitis B or C.

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I have never had pneumonitis or interstitial lung disease.

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I have never taken BRAF or MEK inhibitors.

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

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

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Overall survival

Rates of fever

Response rates

Other study objectives

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%

Blood urea increased

67%

Lipase increased

67%

Fatigue

67%

Headache

50%

Back pain

50%

Nausea

50%

Diarrhoea

50%

Amylase increased

50%

Blood creatine phosphokinase increased

50%

Hyponatraemia

50%

Blood cholesterol increased

50%

Pain in extremity

50%

Blood creatinine increased

33%

Red blood cells urine

33%

Alanine aminotransferase increased

33%

Hypertriglyceridaemia

33%

Blood alkaline phosphatase increased

33%

Blood pressure increased

33%

Hypertension

33%

Disturbance in attention

33%

Labile hypertension

33%

Vomiting

33%

Dyspepsia

33%

Urinary tract infection

33%

Myalgia

33%

Cough

33%

Hypotension

33%

Aspartate aminotransferase increased

33%

Ataxia

33%

Malaise

33%

Abdominal pain

17%

Blood thyroid stimulating hormone decreased

17%

Pharyngitis

17%

Viral infection

17%

Erythema nodosum

17%

Arthritis

17%

Hypernatraemia

17%

Nasal congestion

17%

Anorexia nervosa

17%

Gamma-glutamyltransferase increased

17%

Sweating fever

17%

Penile pain

17%

Hypomagnesaemia

17%

Gingival recession

17%

Confusional state

17%

Cystatin C increased

17%

Syncope

17%

Lip dry

17%

Prothrombin time prolonged

17%

Hyperuricaemia

17%

Arthralgia

17%

Joint effusion

17%

Memory impairment

17%

Acute kidney injury

17%

Proteinuria

17%

Urosepsis

17%

Hyperglycaemia

17%

Dyspnoea

17%

Lymphadenopathy

17%

Skin sensitisation

17%

Paronychia

17%

Leukopenia

17%

Vertigo

100%

80%

60%

40%

20%

Study treatment Arm

Combination Therapy With Dabrafenib and Trametinib in Patients With ECD

Awards & Highlights

No Placebo-Only Group

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

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 3

~270

Trametinib Dimethyl Sulfoxide

2014

Completed Phase 2

~10