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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
Study 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.Check my eligibility
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).See study design
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 belowSelect...
My last cancer treatment did not include BRAF/MEK inhibitors.
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I can take care of myself but might not be able to do heavy physical work.
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My organs and bone marrow are functioning normally.
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I have a tumor that can be easily biopsied.
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My melanoma cannot be surgically removed and is at an advanced stage.
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My side effects from previous treatments are mild or gone.
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My cancer did not respond or I couldn't tolerate treatments targeting PD1/PD-L1 or, if applicable, BRAF and MEK inhibitors.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) and recommended Phase 2 Dose (RP2D)
Overall Response Rate (ORR)
Secondary outcome measures
Median Progression-free Survival (PFS)
Overall Survival (OS)
Side effects data
From 2023 Phase 3 trial • 231 Patients • NCT0182811270%
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%
Rash
11%
Electrocardiogram Qt Prolonged
11%
Dyspnoea
10%
Arthralgia
10%
Nasopharyngitis
10%
Musculoskeletal Pain
9%
Pruritus
9%
Dizziness
9%
Hypokalaemia
8%
Musculoskeletal Chest Pain
7%
Hyperglycaemia
7%
Insomnia
6%
Amylase Increased
6%
Neck Pain
5%
Alopecia
5%
Dry Skin
5%
Anaemia
5%
Malaise
5%
Pain In Extremity
4%
Pleural Effusion
4%
General Physical Health Deterioration
4%
Pneumonia
4%
Stomatitis
4%
Productive Cough
3%
Neutropenia
3%
Respiratory Failure
3%
Paraesthesia
3%
Oedema Peripheral
3%
Pericardial Effusion
3%
Myalgia
2%
Dehydration
2%
Leukopenia
2%
White Blood Cell Count Decreased
2%
Respiratory Tract Infection
2%
Epilepsy
2%
Atrial Fibrillation
2%
Muscular Weakness
1%
Pericarditis
1%
Visual Field Defect
1%
Neuropathy Peripheral
1%
Petit Mal Epilepsy
1%
Lower Respiratory Tract Infection
1%
Gastrointestinal Obstruction
1%
Gastrointestinal Perforation
1%
Lung Infiltration
1%
Cerebrovascular Accident
1%
Loss Of Consciousness
1%
Urinary Bladder Rupture
1%
Lenticular Opacities
1%
Dysphagia
1%
Electrocardiogram T Wave Inversion
1%
Faecaloma
1%
Jaundice
1%
Hyponatraemia
1%
Mobility Decreased
1%
Aphasia
1%
Biliary Tract Infection
1%
Brain Mass
1%
Typhoid Fever
1%
Surgery
1%
Neutrophil Count Decreased
1%
Chest Pain
1%
Cognitive Disorder
1%
Coordination Abnormal
1%
Depressed Level Of Consciousness
1%
Hypoxia
1%
Interstitial Lung Disease
1%
Respiratory Distress
1%
Deep Vein Thrombosis
1%
Seizure
1%
Atrial Flutter
1%
Myocardial Ischaemia
1%
Pathological Fracture
1%
Metastases To Central Nervous System
1%
Tumour Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ceritinib
Chemotherapy
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
~1550
Ceritinib
2013
Completed Phase 3
~1030
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,455 Total Patients Enrolled
43 Trials studying Melanoma
3,191 Patients Enrolled for Melanoma
Novartis PharmaceuticalsIndustry Sponsor
2,863 Previous Clinical Trials
4,199,308 Total Patients Enrolled
51 Trials studying Melanoma
30,877 Patients Enrolled for Melanoma
Zeynep Eroglu, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
3 Previous Clinical Trials
60 Total Patients Enrolled
3 Trials studying Melanoma
60 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My last cancer treatment did not include BRAF/MEK inhibitors.I have stable brain metastases not needing steroids, or no brain metastases.I agree to use effective birth control during and for 90 days after the study.I have had cancer before, but it's under control and I'm not currently on cancer treatment.I am on medication that cannot be stopped for the study, including those affecting heart rhythm or requiring careful monitoring.I am not allergic to trametinib, ceritinib, or their ingredients.I have serious heart issues or had a recent heart event.I do not have any severe health or mental conditions that could affect my participation in the study.I have had lung conditions that affected my daily activities or needed treatment.I have a digestive issue that affects how I absorb medication or I can't swallow pills.I have had radiation treatment before.I can take care of myself but might not be able to do heavy physical work.My organs and bone marrow are functioning normally.You have a tumor that can be measured using specific guidelines called RECIST 1.1.I have a tumor that can be easily biopsied.My melanoma cannot be surgically removed and is at an advanced stage.My side effects from previous treatments are mild or gone.My cancer did not respond or I couldn't tolerate treatments targeting PD1/PD-L1 or, if applicable, BRAF and MEK inhibitors.
Research Study Groups:
This trial has the following groups:- Group 1: Trametinib + Ceritinib Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions are typically addressed with Ceritinib?
"Ceritinib may be used to address metastatic melanoma, unresectable malignant skin cancer and medical directives of an advanced nature."
Answered by AI
How many participants is this medical experiment recruiting?
"Unfortunately, this trial has concluded its recruitment process. Initially posted on June 27th 2018 and last edited November 10th 2022, it no longer requires more participants. However, there are 753 different studies for melanoma and 101 trials for Ceritinib actively recruiting new members."
Answered by AI
Are subjects being accepted into this research experiment at present?
"According to the clinicaltrials.gov portal, this particular trial has ceased recruiting participants; it was posted on June 27th 2018 and last updated November 10th 2022. However, 854 other trials are still attempting to enlist patients at present."
Answered by AI
Can you provide additional information about the experimental studies carried out with Ceritinib?
"To date, there are 8 Phase 3 trials and a total of 101 studies examining the efficacy of Ceritinib. The majority of these clinical investigations occur in Tampa, Florida but 6603 other sites around the world have also joined this research effort."
Answered by AI
Has Ceritinib been given the greenlight by the FDA?
"Based on the limited data available, our team at Power evaluated Ceritinib to be a safety rating of 1. As this is phase one trial, there are few studies outlining its efficacy or overall safety."
Answered by AI
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