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New combo shows promise for Tough-to-Treat skin cancer

NCT ID NCT06346067

Disease control Sponsor: Erasca, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new two-drug combination (naporafenib + trametinib) in people with advanced NRAS-mutant melanoma that has already been treated. The goal is to see if the combo works better than standard treatments at slowing cancer growth and extending life. About 78 adults with this specific genetic type of skin cancer will take part.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

78 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Dec 2028

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

18 to 99 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.

Key Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Age ≥ 18 years 3. Histologically or cytologically confirmed unresectable or metastatic cutaneous (includes acral) melanoma. 4. Documentation of an NRAS mutation (tumor tissue or blood) prior to first dose of study drug(s) as determined locally with an analytically validated assay in a certified testing laboratory. 5. Archival tumor tissue collected within 5 years prior to enrollment must be confirmed to be available at the time of Screening, which may be submitted before or after enrollment for exploratory biomarker analysis. 6. Must have received an anti-PD-1/L1 based regimen (monotherapy or combination). Patient must have documented disease progression either while receiving therapy or within 12 weeks of last dose of the most recent anti-PD-1/L1 based regimen; the patient is eligible if they have received other therapies between the most recent anti-PD-1/L1 based regimen and enrollment. 7. ECOG performance status 0, 1 or 2 8. Presence of at least 1 measurable lesion according to RECIST v1.1 9. Able to swallow oral medication. Key Exclusion Criteria: 1. Patients with uveal or mucosal melanoma 2. Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor 3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug(s) (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection) 4. 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 syndrome) 5. LVEF \<50% 6. Symptomatic CNS metastases that are neurologically unstable. Patients with controlled CNS metastases are eligible. 7. Patients receiving treatment with herbal medicine known to cause liver toxicity, which cannot be discontinued 7 days prior to first dose of study drug(s) and for the duration of the study. 8. Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma metastatic melanoma

As listed by the trial registrant

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

Advanced or metastatic NRAS-mutant melanoma

Contacts and locations

Locations

  • APHP - Hopital Saint Louis

    Paris, 9001, France

  • Alfred Hospital

    Melbourne, 3004, Australia

  • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de la Timone

    Marseille, 13005, France

  • Azienda Sanitaria Universitaria del Friuli Centrale

    Udine, 33100, Italy

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • CHRU de Lille - Hôpital Claude Huriez

    Lille, 59000, France

  • CHU Dijon Bourgogne - Hopital Francois Mitterand (Hopital du Bocage)

    Dijon, 21079, France

  • CLCC Institute Gustave Roussy

    Villejuif, 94805, France

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Centre Hospitalier Lyon-Sud

    Lyon, 69310, France

  • Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre

    Bordeaux, 33075, France

  • Centre Hospitalier du Mans

    Le Mans, 72000, France

  • Christie Hospital

    Manchester, M20 4GJ, United Kingdom

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Fakultni nemocnice Hradec Kralove

    Nový Hradec Králové, 50005, Czechia

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Hollywood Private Hospital

    Nedlands, Western Australia, 6009, Australia

  • Hospital Ambroise Pairs

    Paris, 75010, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)

    Barcelona, 08035, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, 33011, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • IRCCS Istituto Nazionale Tumori Regina Elena

    Roma, 00144, Italy

  • Isala Ziekenhuis

    Amsterdam, 8025, Netherlands

  • Istituto Dermopatico dell Immacolata IDI-IRCCS

    Roma, 00167, Italy

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario Sa

    Milan, 20132, Italy

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZC, Netherlands

  • Masarykuv Onkologicky Ustav-MOU

    Brno, 65653, Czechia

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 70121, United States

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic - Florida

    Jacksonville, Florida, 70121, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A3J1, Canada

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Ochsner Clinic Foundation

    Jefferson, Louisiana, 70121, United States

  • Peter MacCallum Cancer Institute

    Melbourne, Victoria, 3000, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3J 3R4, Canada

  • Radboud University

    Nijmegen, 6525 GA, Netherlands

  • Royal Devon and Exeter Hospital

    Exeter, EX25DW, United Kingdom

  • Royal Preston Hospital

    Preston, Lancashire, PR29H, United Kingdom

  • SCRI Oncology Partners (formerly Tennessee Oncology)

    Nashville, Tennessee, 37203, United States

  • Sanatorium Profesora Arenbergera

    Prague, 1502, Czechia

  • Sarah Cannon Research Institute - HCA Healthcare

    City of London, London, W1G 6AD, United Kingdom

  • Tasman Health Care

    Southport, Queensland, 4215, Australia

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • Texas Oncology- Austin Midtown

    Austin, Texas, 78705, United States

  • The Melanoma and Skin Care Institute

    Englewood, Colorado, 80113, United States

  • The Royal Marsden NHS Foundation Trust

    London, SM2 5PT, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • The University of Utah - Huntsman Cancer Institute (HCI)

    Salt Lake City, Utah, 84112, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66205, United States

  • University of Miami Sylvester Cancer

    Miami, Florida, 33136, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502-1871, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States