RecruitingPhase 2Phase 3NCT06697301

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

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)

Sponsor

Eikon Therapeutics

Enrollment

740 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Melanoma

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new experimental drug (EIK1001) combined with the immunotherapy pembrolizumab versus pembrolizumab alone as the first treatment for advanced melanoma (skin cancer that has spread or cannot be surgically removed). **You may be eligible if...** - You are 18 years or older - You have advanced (unresectable stage 3 or stage 4) melanoma confirmed by biopsy - You are eligible for standard treatment with pembrolizumab - You have at least one measurable tumor on imaging - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have previously received immunotherapy for melanoma - You have active autoimmune disease - You have significant organ problems that would prevent safe treatment - You have active brain metastases requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEIK1001

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

DRUGPembrolizumab (KEYTRUDA® )

Pembrolizumab is a PD-1 inhibitor.

Locations(77)

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

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

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

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, Isère, France

Hôpital La Timone

Marseille, Marseille, France

CHU Rouen

Rouen, Rouen, France

Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, Germany

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 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

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

Humanitas Gavazzeni Bergamo

Bergamo, Province of Bergamo, 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

Uniwersyteckie Centrum Kliniczne

Gdansk, Gdańsk, Poland

Prezychodnia Lekarska KOMED Roman Karaszewski

Konin, Konin, Poland

Mazowiecki Szpital Wojewódzki, Siedlckie Centrum Onkologii

Siedlce, Siedlce, Poland

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

Cape Town Oncology Trials

Cape Town, Western Cape, South Africa

TASK Eden

George Central, Western Cape, South Africa

Hospital Universitari Dexeus

Barcelona, Barcelona, Spain

Vall d' Hebron Institute of Oncology

Barcelona, Barcelona, 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

Hospital 12 de Octubre

Usera, Madrid, 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

Guy's and St Thomas' NHS Foundation Trust

London, England, United Kingdom

Sarah Cannon Research Institute London

London, England, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06697301

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