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New drug cocktail targets Hard-to-Treat melanoma

NCT ID NCT03501368

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a combination of two oral drugs, trametinib and ceritinib, in 27 people with advanced melanoma that had stopped responding to prior treatments. The main goals were to find a safe dose and see if the combination could shrink tumors. The study is complete, but results are not yet widely available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trametinib and ceritinib (oral drugs)
What this could lead to
If it works, this combination could offer a new treatment option for people with advanced melanoma that no longer responds to standard therapies.
What could go wrong
This is a very early, small phase 1 trial focused on safety and dosing, not on proving effectiveness. The combination may cause significant side effects and may not shrink tumors in most patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

27 people

The number who actually took part.

Started

Jun 2018

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of advanced/unresectable melanoma (AJCC v.8 Stage 3C/D/4) * Measurable disease, defined as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Must have at least one tumor site accessible for a biopsy * Documented disease refractory to at least one PD1/PD-L1 (+/- CTLA-4) inhibitor treatment, or intolerance to these drugs and if BRAFV600-mutant melanoma, refractory disease to at least one BRAF and MEK inhibitor (defined as progression while on treatment), or intolerance to these drugs * Last line of treatment prior to study enrollment must not have been BRAF/MEK inhibitor therapy * Prior treatment-related toxicity resolved to ≤ Grade 2 or baseline * Prior radiation allowed * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 90 days after completion of trametinib + ceritinib administration. * Participants must have normal organ and marrow function. Exclusion Criteria: * Potential participants with known hypersensitivity to any of the excipients of trametinib, ceritinib (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate). * An untreated or uncontrolled brain metastases or evidence of leptomeningeal disease. Patients with asymptomatic brain metastases or previously treated brain metastases that are stable (i.e., not requiring corticosteroids) at the time of study start will be eligible. * Previous malignancy is not an exclusion provided that the other malignancy is considered under control, patient is not on concomitant anti-cancer drug therapy, and target lesions from melanoma are clearly defined for response assessment. * Other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results. * Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as: 1. unstable angina within 6 months prior to screening; 2. myocardial infarction within 6 months prior to screening; 3. history of documented congestive heart failure (New York Heart Association functional classification III-IV); 4. cardiac arrhythmias not controlled with medication; 5. Corrected QT (QTcF) \>470 ms at baseline * A history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention). (Note, this does NOT include immune-mediated pneumonitis) * Impaired gastrointestinal (GI) function or GI disease that may alter absorption of study drugs or inability to swallow * Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to start of treatment with study drugs and for the duration of participation: 1. Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes 2. Strong inhibitors or strong inducers of CYP3A4/5, and Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, and/or CYP2C9 3. Therapeutic doses of warfarin sodium (Coumadin) or any other coumadin-derived anti-coagulant. Anticoagulants not derived from warfarin are allowed (e.g., dabigatran, rivaroxaban, apixaban). 4. Unstable or increasing doses of corticosteroids in the 5 days before first dose of study treatment. 5. Enzyme-inducing anticonvulsive agents

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

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