← Back to Search

Kinase Inhibitor

Trametinib + Ceritinib for Melanoma

Phase 1

Waitlist Available

Led By Zeynep Eroglu, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Last line of treatment prior to study enrollment must not have been BRAF/MEK inhibitor therapy

Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Must not have

Potential participants with known hypersensitivity to any of the excipients of trametinib, ceritinib (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)

Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as: unstable angina within 6 months prior to screening; myocardial infarction within 6 months prior to screening; history of documented congestive heart failure (New York Heart Association functional classification III-IV); cardiac arrhythmias not controlled with medication; Corrected QT (QTcF) >470 ms at baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for melanoma that has progressed despite other treatments. The goal is to see if this new combination is more effective than current treatments and has fewer side effects.

Who is the study for?

This trial is for adults with advanced melanoma that can't be surgically removed and who have already tried certain therapies without success. They must be in relatively good health, able to use birth control, and have tumors measurable by standard criteria. People with severe allergies to the drugs' ingredients, uncontrolled brain metastases, recent heart issues, or those on conflicting medications are excluded.

What is being tested?

The study tests a combination of two drugs: Trametinib and Ceritinib. It aims to see if this combo is effective for patients whose melanoma has worsened despite previous treatments including PD1/PD-L1 inhibitors (and BRAF/MEK inhibitors if they have a specific mutation).

What are the potential side effects?

Possible side effects include allergic reactions to drug components, heart problems like irregular heartbeat or chest pain, lung issues such as pneumonitis, gastrointestinal disturbances affecting absorption of the drugs, and general risks associated with cancer treatments.

Eligibility Criteria

Inclusion Criteria

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

Select...

My last cancer treatment did not include BRAF/MEK inhibitors.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My organs and bone marrow are functioning normally.

Select...

I have a tumor that can be easily biopsied.

Select...

My melanoma cannot be surgically removed and is at an advanced stage.

Select...

My side effects from previous treatments are mild or gone.

Select...

My cancer did not respond or I couldn't tolerate treatments targeting PD1/PD-L1 or, if applicable, BRAF and MEK inhibitors.

Exclusion Criteria

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

Select...

I am not allergic to trametinib, ceritinib, or their ingredients.

Select...

I have serious heart issues or had a recent heart event.

Select...

I have had lung conditions that affected my daily activities or needed treatment.

Select...

I have a digestive issue that affects how I absorb medication or I can't swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD) and recommended Phase 2 Dose (RP2D)

Overall Response Rate (ORR)

Secondary study objectives

Median Progression-free Survival (PFS)

Overall Survival (OS)

Side effects data

From 2023 Phase 3 trial • 231 Patients • NCT01828112

70%

Diarrhoea

63%

Nausea

50%

Vomiting

43%

Alanine Aminotransferase Increased

42%

Decreased Appetite

37%

Aspartate Aminotransferase Increased

30%

Weight Decreased

27%

Fatigue

23%

Blood Alkaline Phosphatase Increased

23%

Gamma-Glutamyltransferase Increased

22%

Back Pain

22%

Asthenia

22%

Abdominal Pain

19%

Headache

19%

Constipation

19%

Blood Creatinine Increased

16%

Abdominal Pain Upper

15%

Pyrexia

14%

Cough

12%

Non-Cardiac Chest Pain

11%

Electrocardiogram Qt Prolonged

11%

Rash

11%

Dyspnoea

10%

Arthralgia

10%

Nasopharyngitis

10%

Musculoskeletal Pain

Dizziness

Pruritus

Hypokalaemia

Musculoskeletal Chest Pain

Hyperglycaemia

Insomnia

Amylase Increased

Neck Pain

Anaemia

Alopecia

Dry Skin

Malaise

Pain In Extremity

Pleural Effusion

General Physical Health Deterioration

Pneumonia

Stomatitis

Productive Cough

Neutropenia

Respiratory Failure

Paraesthesia

Oedema Peripheral

Pericardial Effusion

Myalgia

Dehydration

Leukopenia

White Blood Cell Count Decreased

Respiratory Tract Infection

Epilepsy

Atrial Fibrillation

Muscular Weakness

Deep Vein Thrombosis

Cerebrovascular Accident

Interstitial Lung Disease

Cognitive Disorder

Hypoxia

Pericarditis

Lower Respiratory Tract Infection

Petit Mal Epilepsy

Visual Field Defect

Neuropathy Peripheral

Gastrointestinal Obstruction

Gastrointestinal Perforation

Lung Infiltration

Loss Of Consciousness

Urinary Bladder Rupture

Lenticular Opacities

Dysphagia

Electrocardiogram T Wave Inversion

Faecaloma

Jaundice

Hyponatraemia

Mobility Decreased

Aphasia

Biliary Tract Infection

Brain Mass

Typhoid Fever

Surgery

Neutrophil Count Decreased

Chest Pain

Coordination Abnormal

Depressed Level Of Consciousness

Respiratory Distress

Seizure

Atrial Flutter

Myocardial Ischaemia

Pathological Fracture

Metastases To Central Nervous System

Tumour Flare

100%

80%

60%

40%

20%

Study treatment Arm

Ceritinib

Chemotherapy

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: Trametinib + Ceritinib TreatmentExperimental Treatment2 Interventions

Study treatment will be given in cycles. Each cycle will be 4 weeks (28 days). Post-Treatment (follow-up) Period: Participants will return to the study site between 30-40 days after the last dose of trametinib + ceritinib for an end-of-treatment assessment. Additional follow-up will occur for related Adverse Events (AEs) that are not resolved by this time and related Serious Adverse Events (SAEs) that occur after the time of this visit. Participants will be followed for survival every 3 months for the first year following end of treatment, and then every 6 months for up to 5 years after end of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib

2014

Completed Phase 2

~1630

Ceritinib

2013

Completed Phase 3

~1030