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New hope for advanced melanoma: experimental combo enters late-stage trial

NCT ID NCT06697301

Disease control Sponsor: Eikon Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether adding an experimental drug (EIK1001) to standard immunotherapy (pembrolizumab) helps people with advanced melanoma live longer without their cancer growing. About 740 adults with stage 3 or 4 melanoma that cannot be removed by surgery will receive either the combination or a placebo plus pembrolizumab. The main goals are to see if the new combo improves survival and slows cancer progression.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 740 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2040

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 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: To be eligible for inclusion in this study, participants must: * Be ≥ 18 years of age on the day of signing of informed consent. * Have a life expectancy of at least 3 months. * Have histologically or cytologically confirmed Stage 3 (unresectable) or Stage 4 metastatic melanoma per AJCC 8th ed. and be eligible for standard therapy with pembrolizumab. * Have at least 1 lesion with measurable disease at Baseline by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by assessment of local site Investigator/radiologist. * Have known BRAF V600 mutation status or consent to BRAF V600 mutation testing per local institutional standards during the screening period * Have completed prior radiotherapy at least 2 weeks prior to study treatment administration. * Have an ECOG Performance Status of 0 to 1. * Have adequate organ and marrow function as defined by normal CBC, coagulation, serum chemistry and liver function tests on specimens collected within 10 days of treatment start. * Have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication (applies to women of childbearing potential \[WOCBP\]). * Be willing to use either 2 adequate methods of contraception, 1 adequate method plus a hormonal method of contraception, or be willing to abstain from heterosexual activity throughout the study (Visit 1 to 120 days after the last dose of study therapy; applies to WOCBP who are not menopausal for \> 2 years, post-hysterectomy/oophorectomy, or surgically sterilized). * Agree to use an approved adequate contraceptive method throughout the study (Visit 1 to 120 days after the last dose of study therapy; applies to sexually active male participants with a partner who is WOCBP). * Be willing and able to provide written, informed consent for the study. Exclusion Criteria: A participant is excluded from the study if any of the following criteria apply: * Has melanoma of ocular origin. * Is currently enrolled in or has recently participated in a study of an IMP and received an IMP within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001 or placebo. * Prior to the 1St dose of EIK1001 or placebo, the prospective participant has received systemic therapy for advanced melanoma. * Note: prior adjuvant or neoadjuvant melanoma therapies (such as anti-PD-1 or anti CTLA 4 therapies or BRAF/MEK inhibitors) are permitted if all related AEs have either returned to Baseline or stabilized, with a minimum of 6 months between the last dose of prior therapy and documented disease progression. * Experienced a ≥ Grade 3 AE while receiving prior anti PD 1 therapy. * Has had major surgery (\< 3 weeks prior to the first dose). * Has received a live-virus vaccination within 30 days of the first dose of study treatment. * Has a known history of prior malignancy, unless the participant has undergone potentially curative therapy with no evidence of disease recurrence for 5 years. * Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate if they are clinically stable for at least 4 weeks with no evidence of new or enlarging brain metastases. There must be no need for immunosuppressive doses of glucocorticoids for at least 2 weeks prior to study treatment administration. * There is a mean resting QTcF \> 470 ms on triplicate electrocardiograms. * There is active autoimmune disease that has required systemic treatment in the past 2 years. The following autoimmune conditions are permitted: Type 1 diabetes, hypothyroidism (on hormone replacement), or- vitiligo, psoriasis and alopecia as long as no systemic treatment is required. * There is either chronic treatment with systemic steroids, other immunosuppressive medication, or either of these has been administered within 14 days of start of study treatment. * Note: Participants with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections are eligible. Steroid replacement for adrenal insufficiency is also permitted. * There is a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/ interstitial lung disease. * There are any active infections requiring therapy. * There is uncontrolled human immunodeficiency virus (HIV) infection. HIV-infected participants with well-controlled HIV may enroll. * There is a positive test result for hepatitis B virus (HBV) or HCV indicating presence of virus (it is expected that all participants will have been serologically tested for hepatitis B in advance of this study, with HBsAG, anti-HBc IgG, and anti-HBs as per ASCO 2020 Provisional Clinical Opinion \[PCO\] on universal Serologic testing for hepatitis B at the onset of anticancer therapy; screening should also include an anti-HCV test prior to start of cancer treatment: * There is a history or clinical evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study or interfere with the participant's participation for the full duration of the study * Known psychiatric or substance abuse disorder that would interfere with cooperation with study requirements. * There is a known history of regular illicit drug use and/or recent history (within the last year) of substance abuse (including alcohol). * Participant is pregnant, breastfeeding, or planning to conceive or father children within the projected duration of the study. * Participant is currently receiving medications known to be strong inhibitors or inducers of CYP3A4 and CYP1A2.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma metastatic melanoma Neoplasm Metastasis

As listed by the trial registrant

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

Advanced melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    107 sites in 24 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A Paré

    RECRUITING

    Boulogne, Boulogne, 92104, France

  • Aalborg University Hospital

    RECRUITING

    Aalborg, Nord Jutland, 9000, Denmark

  • Aarhus Universitetshospital

    RECRUITING

    Aarhus, Central Jutland, 8200, Denmark

  • Abraham Oncology

    RECRUITING

    Richards Bay, KwaZulu-Natal, 3900, South Africa

  • Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

    RECRUITING

    Kortrijk, West-Vlaanderen, 8500, Belgium

  • Auckland City Hospital

    RECRUITING

    Auckland, New Zealand, 1023, New Zealand

  • Belfast City Hospital, Belfast Health and Social Care Trust

    RECRUITING

    Belfast, Belfast, BT9 7AB, United Kingdom

  • Bioresearch Partner

    RECRUITING

    Hialeah, Florida, 33013, United States

  • CHU Lille

    RECRUITING

    Polonovski, Lille Cedex, 59037, France

  • CHU Rouen

    RECRUITING

    Rouen, Rouen, 76031, France

  • Cancer Care Wollongong

    RECRUITING

    Wollongong, New South Wales, 2500, Australia

  • Cancercare Port Elizabeth - Langenhoven Drive Oncology Centre

    RECRUITING

    Port Elizabeth, Eastern Cape, 6045, South Africa

  • Cape Town Oncology Trials

    RECRUITING

    Cape Town, Western Cape, 7570, South Africa

  • Centre Hospitalier Lyon-Sud

    RECRUITING

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

  • Centre Hospitalier Universitaire (CHU) Nice

    RECRUITING

    Nice, PACA, 06200, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    RECRUITING

    La Tronche, Isère, 38700, France

  • Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

    RECRUITING

    Yvoir, Namur, B-5530, Belgium

  • Charite Department of Dermatology, Venereology and Allergology

    RECRUITING

    Berlin, State of Berlin, 10115, Germany

  • Christchurch Public Hospital

    RECRUITING

    Christchurch, Christchurch, 8011, New Zealand

  • Clinica Oncologia Delle Marche

    RECRUITING

    Ancona, The Marches, 60126, Italy

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, Brussels Capital, 1200, Belgium

  • Curo Oncology

    RECRUITING

    Pretoria, Pretoria, 0084, South Africa

    Contact Email: •••••@•••••

  • Drammen Hospital

    RECRUITING

    Drammen, Oslofjord, 3004, Norway

  • Eastern Health

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • Elbe Kliniken Stade-Buxtehude

    RECRUITING

    Buxtehude, Lower Saxony, 21614, Germany

  • Ella Lemelbaum Institute for Immuno-Oncology and Melanoma

    RECRUITING

    Ramat Gan, Ramat Gan, 5262100, Israel

  • Fachklinik Hornheide

    RECRUITING

    Münster, 48157, Germany

  • Gabrail Cancer Center Research LLC

    RECRUITING

    Canton, Ohio, 44718, United States

  • Genesis Cancer and Blood Institute

    RECRUITING

    Hot Springs, Arkansas, 71913, United States

  • GenesisCare Madrid - Hospital San Francisco de Asís

    RECRUITING

    Madrid, Madrid, 28002, Spain

  • Guy's and St Thomas' NHS Foundation Trust

    RECRUITING

    London, England, SE1 9RT, United Kingdom

  • Gävle Sjukhus

    RECRUITING

    Gävle, Gävleborg County, 801 88, Sweden

  • H. Germans Trias I Pujol (ICO-Badalona)

    RECRUITING

    Badalona, Badalona, 08916, Spain

  • HM CIOCC

    RECRUITING

    Madrid, Madrid, 28050, Spain

  • Helios Clinical Research

    RECRUITING

    Los Angeles, California, 90015, United States

  • Helsinki University Hospital

    RECRUITING

    Helsinki, Uusimaa, 00029, Finland

  • Hospital 12 de Octubre

    RECRUITING

    Usera, Madrid, 28031, Spain

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, Madrid, 28007, Spain

  • Hospital Regional Universitario

    RECRUITING

    Málaga, Malaga, 29011, Spain

    Contact Email: •••••@•••••

  • Hospital Saint Andre

    RECRUITING

    Bordeaux, 33075, France

  • Hospital Universitari Dexeus

    RECRUITING

    Barcelona, Barcelona, 08028, Spain

  • Hospital Universitario Lucus Augusti

    RECRUITING

    Lugo, Galicia, 27003, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Málaga, 29010, Spain

  • Hospital da Luz Lisboa

    RECRUITING

    Lisbon, Lisbon District, 1500-650, Portugal

  • Humanitas Gavazzeni Bergamo

    RECRUITING

    Bergamo, Province of Bergamo, 24125, Italy

  • Hôpital Bichat AP-HP Université Paris Cité

    RECRUITING

    Paris, Paris, 75018, France

  • Hôpital La Timone

    RECRUITING

    Marseille, Marseille, 13385, France

  • ICO Saint Herblain

    RECRUITING

    Saint-Herblain, Pays de la Loire Region, 44800, France

  • INCLIVA Instituto de Investigación Sanitaria

    RECRUITING

    Valencia, Valencia, 46010, Spain

  • IPO Lisboa

    RECRUITING

    Lisbon, Lisbon District, 1099-023, Portugal

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Milano, 20132, Italy

  • IVO - Fundacion Instituto Valenciano de Oncologia

    RECRUITING

    Valencia, Valencia, 46009, Spain

  • Icon Cancer Centre Chermside

    RECRUITING

    Chermside, Queensland, 4032, Australia

  • Institut Català d'Oncologia Girona (ICO Girona)

    RECRUITING

    Girona, Girona, 17007, Spain

  • Ironwood Cancer & Research Centers

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Johannes Wesling Klinikum Minden

    RECRUITING

    Minden, North Rhine-Westphalia, 32429, Germany

  • Kantonsspital Graubünden

    RECRUITING

    Chur, Chur, 7000, Switzerland

  • Karolinska University Hospital

    RECRUITING

    Stockholm, Södermanland County, 17176, Sweden

  • Klinik für Dermatologie, Venerologie und Allergologie

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Buk-Gu, Daegu, 41404, South Korea

  • Maria Sklodowska-Curie National Cancer Research Institute

    RECRUITING

    Warsaw, Warsaw, 02-781, Poland

  • Masaryk Memorial Cancer Institute

    RECRUITING

    Brno, Brno, 65653, Czechia

  • Mazowiecki Szpital Wojewódzki, Siedlckie Centrum Onkologii

    RECRUITING

    Siedlce, Siedlce, 08-110, Poland

  • MidAmerica Cancer Care

    RECRUITING

    Kansas City, Missouri, 64132, United States

  • Military Medical Academy- Department of Oncology

    RECRUITING

    Belgrade, Belgrade, 11000, Serbia

  • National Institute of Oncology

    RECRUITING

    Budapest, Budapest, 1122, Hungary

  • Nordland Hospital Trust

    RECRUITING

    Bodø, Bodø, N-8005, Norway

  • Oslo University Hospital - The Norwegian Radium Hospital

    RECRUITING

    Oslo, Oslo, 0310, Norway

  • Oulu University Hospital

    RECRUITING

    Oulu, Oulu, 90230, Finland

  • Peninsula and South Eastern Haematology and Oncology Group

    RECRUITING

    Frankston, Victoria, 3199, Australia

  • Prezychodnia Lekarska KOMED Roman Karaszewski

    RECRUITING

    Konin, Konin, 62-500, Poland

  • Providence Medical Foundation

    RECRUITING

    Santa Rosa, California, 95403, United States

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, Petach Tikva, 4941492, Israel

  • San Pedro de Alcántara Hospital

    RECRUITING

    Cáceres, Cáceres, 10003, Spain

  • Sarah Cannon Research Institute London

    RECRUITING

    London, England, W1G6AD, United Kingdom

  • Seoul National University Hospital

    RECRUITING

    Jongno-gu, Seoul, 03080, South Korea

  • Soroka medical center

    RECRUITING

    Beersheba, Be'er Sheva, 8410101, Israel

  • Southern Adelaide Local Health Network Incorporated Flinders Medical Centre

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Sunnybrook Research Ins<tute

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • TASK Eden

    RECRUITING

    George Central, Western Cape, 6530, South Africa

  • Tampere University Hospital

    RECRUITING

    Tampere, Pirkanmaa, 33521, Finland

  • Tel Aviv Medical Center

    RECRUITING

    Tel Aviv, Tel Aviv, 6423906, Israel

  • The Center for Cancer and Blood Disorders

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • The Medical Oncology Centre of Rosebank

    RECRUITING

    Saxonwold, Gauteng, 2196, South Africa

  • UCHealth Memorial Hospital Central

    RECRUITING

    Colorado Springs, Colorado, 80909, United States

  • UOC Immunoterapia Oncologica

    RECRUITING

    Siena, Tuscany, 53100, Italy

  • Universitaetsklinikum Tuebingen (UKT)

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    RECRUITING

    Leuven, Vlaams Brabant, 3000, Belgium

  • Universitat Leipzig

    RECRUITING

    Saxony, Leipzig, 04103, Germany

  • University Hospital Hradec Kralove

    RECRUITING

    Sokolov, Hradce Kralove, 50009, Czechia

  • University Hospital Southampton

    RECRUITING

    Southampton, Hampshire, SO32 2DA, United Kingdom

  • University Hospital of Jerez

    RECRUITING

    Jerez de La Frontera (Cádiz), Jerez de La Frontera (Cádiz), 11407, Spain

  • University of Mainz Medical Center

    RECRUITING

    Mainz, RLP, 55131, Germany

  • University of Pittsburgh Medical Center(UPMC)-Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Pretoria, Steve Biko Academic Hospital

    RECRUITING

    Pretoria, Gauteng, 0002, South Africa

  • University of Pécs

    RECRUITING

    Pécs, 7632, Hungary

  • Universitätsklinik Hamburg Eppendorf

    RECRUITING

    Martinsried, Free and Hanseatic City of Hamburg, 20246, Germany

  • Universitätsklinikum Graz

    RECRUITING

    Graz, Styria, 8036, Austria

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    RECRUITING

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    RECRUITING

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitätsmedizin Mannheim

    RECRUITING

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • Universitätsspital Zürich

    RECRUITING

    Zurich, Canton of Zurich, 8091, Switzerland

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, Gdańsk, 80-952, Poland

  • Vall d' Hebron Institute of Oncology

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Vitaz Primary Location

    RECRUITING

    Sint-Niklaas, 9100, Belgium

  • Washington University School of Medicine in St. Louis

    RECRUITING

    St Louis, Missouri, 63108, United States

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