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)

Status: Recruiting
Location: See all (75) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Arkansas
Genesis Cancer and Blood Institute
RECRUITING
Hot Springs
Arizona
Ironwood Cancer & Research Centers
RECRUITING
Chandler
California
Helios Clinical Research
RECRUITING
Los Angeles
Providence Medical Foundation
RECRUITING
Santa Rosa
Colorado
UCHealth Memorial Hospital Central
RECRUITING
Colorado Springs
Florida
Bioresearch Partner
RECRUITING
Hialeah
Maryland
The Center for Cancer and Blood Disorders
RECRUITING
Bethesda
Missouri
MidAmerica Cancer Care
RECRUITING
Kansas City
Washington University School of Medicine in St. Louis
RECRUITING
St Louis
Ohio
Gabrail Cancer Center Research LLC
RECRUITING
Canton
Pennsylvania
University of Pittsburgh Medical Center(UPMC)-Hillman Cancer Center
RECRUITING
Pittsburgh
Other Locations
Australia
Southern Adelaide Local Health Network Incorporated Flinders Medical Centre
RECRUITING
Bedford Park
Eastern Health
RECRUITING
Box Hill
Icon Cancer Centre Chermside
RECRUITING
Chermside
Cancer Care Wollongong
RECRUITING
Wollongong
Austria
Universitätsklinikum Graz
RECRUITING
Graz
Belgium
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
Universitair Ziekenhuis Antwerpen
RECRUITING
Edegem
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
RECRUITING
Kortrijk
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
RECRUITING
Leuven
Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne
RECRUITING
Yvoir
Canada
Sunnybrook Research Ins<tute
RECRUITING
Toronto
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus Universitetshospital
RECRUITING
Aarhus
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Oulu University Hospital
RECRUITING
Oulu
Tampere University Hospital
RECRUITING
Tampere
France
Centre Hospitalier Universitaire Grenoble Alpes
RECRUITING
La Tronche
Hôpital La Timone
RECRUITING
Marseille
Centre Hospitalier Lyon-Sud
RECRUITING
Pierre-bénite
CHU Rouen
RECRUITING
Rouen
Germany
Elbe Kliniken Stade-Buxtehude
RECRUITING
Buxtehude
Universitätsklinikum Schleswig-Holstein - Campus Kiel
RECRUITING
Kiel
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
RECRUITING
Lübeck
University of Mainz Medical Center
RECRUITING
Mainz
Universitätsmedizin Mannheim
RECRUITING
Mannheim
Johannes Wesling Klinikum Minden
RECRUITING
Minden
Universitat Leipzig
RECRUITING
Saxony
Universitätsklinikum Tübingen
RECRUITING
Tübingen
Israel
Soroka medical center
RECRUITING
Beersheba
Rabin Medical Center
RECRUITING
Petah Tikva
Ella Lemelbaum Institute for Immuno-Oncology and Melanoma
RECRUITING
Ramat Gan
Tel Aviv Medical Center
RECRUITING
Tel Aviv
Italy
Humanitas Gavazzeni Bergamo
RECRUITING
Bergamo
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Christchurch Public Hospital
RECRUITING
Christchurch
Norway
Nordland Hospital Trust
RECRUITING
Bodø
Oslo University Hospital - The Norwegian Radium Hospital
RECRUITING
Oslo
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Prezychodnia Lekarska KOMED Roman Karaszewski
RECRUITING
Konin
Mazowiecki Szpital Wojewódzki, Siedlckie Centrum Onkologii
RECRUITING
Siedlce
Portugal
Hospital da Luz Lisboa
RECRUITING
Lisbon
Serbia
Military Medical Academy- Department of Oncology
RECRUITING
Belgrade
South Africa
Cape Town Oncology Trials
RECRUITING
Cape Town
TASK Eden
RECRUITING
George Central
Cancercare Port Elizabeth - Langenhoven Drive Oncology Centre
RECRUITING
Port Elizabeth
University of Pretoria, Steve Biko Academic Hospital
RECRUITING
Pretoria
The Medical Oncology Centre of Rosebank
RECRUITING
Saxonwold
Spain
Hospital Universitari Dexeus
RECRUITING
Barcelona
Vall d' Hebron Institute of Oncology
RECRUITING
Barcelona
Institut Català d'Oncologia Girona (ICO Girona)
RECRUITING
Girona
University Hospital of Jerez
RECRUITING
Jerez De La Frontera (cádiz)
Hospital Universitario Lucus Augusti
RECRUITING
Lugo
GenesisCare Madrid - Hospital San Francisco de Asís
RECRUITING
Madrid
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital 12 de Octubre
RECRUITING
Usera
INCLIVA Instituto de Investigación Sanitaria
RECRUITING
Valencia
IVO - Fundacion Instituto Valenciano de Oncologia
RECRUITING
Valencia
Sweden
Gävle Sjukhus
RECRUITING
Gävle
Karolinska University Hospital
RECRUITING
Stockholm
Switzerland
Kantonsspital Graubünden
RECRUITING
Chur
Universitätsspital Zürich
RECRUITING
Zurich
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
Sarah Cannon Research Institute London
RECRUITING
London
Contact Information
Primary
Krishna Kaza
Kazak@eikontx.com
+1 (516) 675-6163
Backup
Juliette Beaulieu
beaulieuj@eikontx.com
415-940-4170
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2040-12
Participants
Target number of participants: 740
Treatments
Active_comparator: Arm 1
Participants in this arm will receive Placebo and Standard of Care (Pembrolizumab).
Experimental: Arm 2
Participants in this arm will receive EIK1001 (selected dose 1) + Standard of Care (Pembrolizumab).
Experimental: Arm 3
Participants in this arm will receive EIK1001 (selected dose 2) + Standard of Care (Pembrolizumab).
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Eikon Therapeutics

This content was sourced from clinicaltrials.gov

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