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New cocktail of drugs shows promise for Tough-to-Treat melanoma

NCT ID NCT04417621

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial is testing several combinations of experimental drugs (LXH254, LTT462, trametinib, ribociclib) in 134 people with advanced melanoma that has a BRAF or NRAS mutation and has stopped responding to prior treatment. The main goal is to see if these combinations can shrink tumors. The study is active but no longer recruiting new participants.

What this could mean

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

Active substance
LXH254, LTT462, trametinib, ribociclib (oral drugs)
What this could lead to
If successful, this could provide new treatment options for people with advanced melanoma that has stopped responding to other therapies.
What could go wrong
This is an early-phase trial with only 134 participants, so results may not apply to everyone. Drug combinations can cause serious side effects, and the cancer may still progress.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

134 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

12 to 120 years

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: Male or female must be ≥ 12 years For adolescents only (12-17 years): body weight \> 40kg Histologically confirmed unresectable or metastatic cutaneous melanoma Previously treated for unresectable or metastatic melanoma: * Participants with NRAS mutation: * Participants must have received prior systemic therapy for unresectable or metastatic melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally directed anti-neoplastic agents. * A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed. Additional agents administered with CPI are permitted. * To rule out pseudo-progression, participants must have documented confirmed progressive disease as per RECIST v1.1 while on/after treatment with checkpoint inhibitor therapy. Confirmation is not required for patients who remained on treatment for \>6 months. * Participants with BRAFV600 mutant disease: * Participants must have received prior systemic therapy for unresectable or metastatic melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally directed anti-neoplastic agents. Additionally, participants must have received targeted therapy with a RAFi as a single agent or in combination with a MEKi (+/- CPI allowed) as the last prior therapy. * A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed. Additional agents with CPI are permitted. * A maximum of one line of targeted therapy is allowed, and it must be the most recent line of therapy. * Participants must have documented progressive disease as per RECIST v1.1 while on/after treatment with targeted therapy. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes: * ≤ 4 weeks for radiation therapy or ≤ 2 weeks for limited field radiation for palliation prior to the first dose of study treatment. * ≤ 2 weeks for small molecule therapeutics. * ≤ 4 weeks for any immunotherapy treatment including immune checkpoint inhibitors. * ≤ 4 weeks for chemotherapy agents, locally directed anti-neoplastic agents, or other investigational agents. * ≤ 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosourea and mitomycin c. Participants participating in additional parallel investigational drug or medical device studies. All primary central nervous system (CNS) tumors or symptomatic CNS metastases that are neurologically unstable History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes). Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. Other protocol-defined exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma

As listed by the trial registrant

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

Melanoma

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901, United States

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Mayo Rochester

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering

    New York, New York, 10017, United States

  • NYU Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1426ANZ, Argentina

  • Novartis Investigative Site

    North Sydney, New South Wales, 2060, Australia

  • Novartis Investigative Site

    Wooloongabba, Queensland, 4102, Australia

  • Novartis Investigative Site

    Subiaco, Western Australia, 6008, Australia

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Wilrijk, 2610, Belgium

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Marseille, 13885, France

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Villejuif, 94800, France

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    Tübingen, 72076, Germany

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Maastricht, Limburg, 6229 HX, Netherlands

  • Novartis Investigative Site

    Oslo, 0310, Norway

  • Novartis Investigative Site

    Lausanne, 1011, Switzerland

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    Manchester, M20 2BX, United Kingdom

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • Univ of TX MD Anderson Cancer Cntr

    Houston, Texas, 77030, United States

  • University of Pittsburgh Med Center

    Pittsburgh, Pennsylvania, 15213, United States

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