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RECRUITING

NCT06697301

PHASE2/PHASE3

Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.

Sponsor: Eikon Therapeutics

View on ClinicalTrials.gov

Summary

The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.

Official title: A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants With Advanced Melanoma (TeLuRide-006)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

740

Start Date

2025-05-22

Completion Date

2040-12

Last Updated

2026-05-08

Healthy Volunteers

Conditions

Advanced Melanoma

Interventions

DRUG

EIK1001

EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.

DRUG

Pembrolizumab (KEYTRUDA® )

Pembrolizumab is a PD-1 inhibitor.

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.

Locations (107)

Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, United States

Helios Clinical Research

Los Angeles, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Bioresearch Partner

Hialeah, Florida, United States

The Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

MidAmerica Cancer Care

Kansas City, Missouri, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Gabrail Cancer Center Research LLC

Canton, Ohio, United States

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

Pittsburgh, Pennsylvania, United States

Cancer Care Wollongong

Wollongong, New South Wales, Australia

Icon Cancer Centre Chermside

Chermside, Queensland, Australia

Southern Adelaide Local Health Network Incorporated Flinders Medical Centre

Bedford Park, South Australia, Australia

Eastern Health

Box Hill, Victoria, Australia

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Universitätsklinikum Graz

Graz, Styria, Austria

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

Yvoir, Namur, Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Vlaams Brabant, Belgium

Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

Kortrijk, West-Vlaanderen, Belgium

Vitaz Primary Location

Sint-Niklaas, Belgium

Sunnybrook Research Ins<tute

Toronto, Ontario, Canada

Masaryk Memorial Cancer Institute

Brno, Brno, Czechia

University Hospital Hradec Kralove

Sokolov, Hradce Kralove, Czechia

Aarhus Universitetshospital

Aarhus, Central Jutland, Denmark

Aalborg University Hospital

Aalborg, Nord Jutland, Denmark

Oulu University Hospital

Oulu, Oulu, Finland

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Centre Hospitalier Lyon-Sud

Pierre-Bénite, Auvergne-Rhône-Alpes, France

A Paré

Boulogne, Boulogne, France

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, Isère, France

CHU Lille

Polonovski, Lille Cedex, France

Hôpital La Timone

Marseille, Marseille, France

Centre Hospitalier Universitaire (CHU) Nice

Nice, PACA, France

Hôpital Bichat AP-HP Université Paris Cité

Paris, Paris, France

ICO Saint Herblain

Saint-Herblain, Pays de la Loire Region, France

CHU Rouen

Rouen, Rouen, France

Hospital Saint Andre

Bordeaux, France

Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen (UKT)

Tübingen, Baden-Wurttemberg, Germany

Klinik für Dermatologie, Venerologie und Allergologie

Würzburg, Bavaria, Germany

Universitätsklinik Hamburg Eppendorf

Martinsried, Free and Hanseatic City of Hamburg, Germany

Universitat Leipzig

Saxony, Leipzig, Germany

Elbe Kliniken Stade-Buxtehude

Buxtehude, Lower Saxony, Germany

Johannes Wesling Klinikum Minden

Minden, North Rhine-Westphalia, Germany

University of Mainz Medical Center

Mainz, RLP, Germany

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schleswig-Holstein, Germany

Charite Department of Dermatology, Venereology and Allergology

Berlin, State of Berlin, Germany

Fachklinik Hornheide

Münster, Germany

National Institute of Oncology

Budapest, Budapest, Hungary

University of Pécs

Pécs, Hungary

Soroka medical center

Beersheba, Be'er Sheva, Israel

Rabin Medical Center

Petah Tikva, Petach Tikva, Israel

Ella Lemelbaum Institute for Immuno-Oncology and Melanoma

Ramat Gan, Ramat Gan, Israel

Tel Aviv Medical Center

Tel Aviv, Tel Aviv, Israel

IRCCS Ospedale San Raffaele

Milan, Milano, Italy

Humanitas Gavazzeni Bergamo

Bergamo, Province of Bergamo, Italy

Clinica Oncologia Delle Marche

Ancona, The Marches, Italy

UOC Immunoterapia Oncologica

Siena, Tuscany, Italy

Christchurch Public Hospital

Christchurch, Christchurch, New Zealand

Auckland City Hospital

Auckland, New Zealand, New Zealand

Nordland Hospital Trust

Bodø, Bodø, Norway

Oslo University Hospital - The Norwegian Radium Hospital

Oslo, Oslo, Norway

Drammen Hospital

Drammen, Oslofjord, Norway

Uniwersyteckie Centrum Kliniczne

Gdansk, Gdańsk, Poland

Prezychodnia Lekarska KOMED Roman Karaszewski

Konin, Konin, Poland

Mazowiecki Szpital Wojewódzki, Siedlckie Centrum Onkologii

Siedlce, Siedlce, Poland

Maria Sklodowska-Curie National Cancer Research Institute

Warsaw, Warsaw, Poland

IPO Lisboa

Lisbon, Lisbon District, Portugal

Hospital da Luz Lisboa

Lisbon, Lisbon District, Portugal

Military Medical Academy- Department of Oncology

Belgrade, Belgrade, Serbia

Cancercare Port Elizabeth - Langenhoven Drive Oncology Centre

Port Elizabeth, Eastern Cape, South Africa

University of Pretoria, Steve Biko Academic Hospital

Pretoria, Gauteng, South Africa

The Medical Oncology Centre of Rosebank

Saxonwold, Gauteng, South Africa

Abraham Oncology

Richards Bay, KwaZulu-Natal, South Africa

Curo Oncology

Pretoria, Pretoria, South Africa

Cape Town Oncology Trials

Cape Town, Western Cape, South Africa

TASK Eden

George Central, Western Cape, South Africa

Kyungpook National University Chilgok Hospital

Buk-Gu, Daegu, South Korea

Seoul National University Hospital

Jongno-gu, Seoul, South Korea

H. Germans Trias I Pujol (ICO-Badalona)

Badalona, Badalona, Spain

Hospital Universitari Dexeus

Barcelona, Barcelona, Spain

Vall d' Hebron Institute of Oncology

Barcelona, Barcelona, Spain

San Pedro de Alcántara Hospital

Cáceres, Cáceres, Spain

Hospital Universitario Lucus Augusti

Lugo, Galicia, Spain

Institut Català d'Oncologia Girona (ICO Girona)

Girona, Girona, Spain

University Hospital of Jerez

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

GenesisCare Madrid - Hospital San Francisco de Asís

Madrid, Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

HM CIOCC

Madrid, Madrid, Spain

Hospital 12 de Octubre

Usera, Madrid, Spain

Hospital Regional Universitario

Málaga, Malaga, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

IVO - Fundacion Instituto Valenciano de Oncologia

Valencia, Valencia, Spain

INCLIVA Instituto de Investigación Sanitaria

Valencia, Valencia, Spain

Gävle Sjukhus

Gävle, Gävleborg County, Sweden

Karolinska University Hospital

Stockholm, Södermanland County, Sweden

Universitätsspital Zürich

Zurich, Canton of Zurich, Switzerland

Kantonsspital Graubünden

Chur, Chur, Switzerland

Belfast City Hospital, Belfast Health and Social Care Trust

Belfast, Belfast, United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, England, United Kingdom

Sarah Cannon Research Institute London

London, England, United Kingdom

University Hospital Southampton

Southampton, Hampshire, United Kingdom

Clinical Research Directory

Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (107)