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

NCT06697301 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: EIK1001-006KEYNOTE-G04MK-3475-G04
• Study Type: interventional
• Target: 740
• Locations: 20 countries
• Sites: 74

Brief Summary

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

Conditions

Advanced Melanoma

Keywords

Metastatic; Advanced

Outcome Measures

Primary Outcomes (4)

• Progression Free Survival (PFS)

  Progression-free survival (PFS) is defined as the time from the date of randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.

  up to 5 years

• Overall survival (OS)

  Overall survival (OS) defined as the time from randomization to death due to any cause.

  up to 5 years

• Objective Response (OR) (Dose Optimization Only)

  Objective Response (OR; defined as participants who demonstrate confirmed complete response \[CR\] or partial response \[PR\] by Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1 as assessed by the Investigator) (Dose Optimization Only).

  up to 5 years

• Adverse Events (AEs) (Dose Optimization Only)

  Adverse events (AEs), and discontinuation of study treatment due to an AE (Dose Optimization Only). An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  up to 2.5 years

Secondary Outcomes (9)

• Adverse Events (AEs) and Discontinuation of study treatment due to any AE.

  up to 2.5 years

• Objective Response (OR)

  up to 5 years

• Duration of Response (DOR).

  up to 5 years

• Progression Free Survival (PFS)

  up to 5 years

• Objective Response (OR)

  up to 5 years

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Participants in this arm will receive Placebo and Standard of Care (Pembrolizumab).

Drug: Pembrolizumab (KEYTRUDA® )

Arm 2

EXPERIMENTAL

Participants in this arm will receive EIK1001 (selected dose 1) + Standard of Care (Pembrolizumab).

Drug: EIK1001; Drug: Pembrolizumab (KEYTRUDA® )

Arm 3

EXPERIMENTAL

Participants in this arm will receive EIK1001 (selected dose 2) + Standard of Care (Pembrolizumab).

Drug: EIK1001; Drug: Pembrolizumab (KEYTRUDA® )

Interventions

EIK1001 DRUG

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

Arm 2; Arm 3

Pembrolizumab (KEYTRUDA® ) DRUG

Pembrolizumab is a PD-1 inhibitor.

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eikon Therapeutics: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (77)

Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

RECRUITING

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, 71913, United States

RECRUITING

Helios Clinical Research

Los Angeles, California, 90015, United States

RECRUITING

Providence Medical Foundation

Santa Rosa, California, 95403, United States

RECRUITING

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

RECRUITING

Bioresearch Partner

Hialeah, Florida, 33013, United States

RECRUITING

The Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

RECRUITING

MidAmerica Cancer Care

Kansas City, Missouri, 64132, United States

RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63108, United States

RECRUITING

Gabrail Cancer Center Research LLC

Canton, Ohio, 44718, United States

RECRUITING

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

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Cancer Care Wollongong

Wollongong, New South Wales, 2500, Australia

RECRUITING

Icon Cancer Centre Chermside

Chermside, Queensland, 4032, Australia

RECRUITING

Southern Adelaide Local Health Network Incorporated Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

Eastern Health

Box Hill, Victoria, 3128, Australia

RECRUITING

Universitätsklinikum Graz

Graz, Styria, 8036, Austria

RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

Yvoir, Namur, B-5530, Belgium

RECRUITING

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

Kortrijk, West-Vlaanderen, 8500, Belgium

RECRUITING

Sunnybrook Research Ins<tute

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Masaryk Memorial Cancer Institute

Brno, Brno, 65653, Czechia

RECRUITING

University Hospital Hradec Kralove

Sokolov, Hradce Kralove, 50009, Czechia

RECRUITING

Aarhus Universitetshospital

Aarhus, Central Jutland, 8200, Denmark

RECRUITING

Aalborg University Hospital

Aalborg, Nord Jutland, 9000, Denmark

RECRUITING

Oulu University Hospital

Oulu, Oulu, 90230, Finland

RECRUITING

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

RECRUITING

Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

RECRUITING

Centre Hospitalier Lyon-Sud

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

RECRUITING

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, Isère, 38700, France

RECRUITING

Hôpital La Timone

Marseille, Marseille, 13385, France

RECRUITING

CHU Rouen

Rouen, Rouen, 76031, France

RECRUITING

Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Universitat Leipzig

Saxony, Leipzig, 04103, Germany

RECRUITING

Elbe Kliniken Stade-Buxtehude

Buxtehude, Lower Saxony, 21614, Germany

RECRUITING

Johannes Wesling Klinikum Minden

Minden, North Rhine-Westphalia, 32429, Germany

RECRUITING

University of Mainz Medical Center

Mainz, RLP, 55131, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

Soroka medical center

Beersheba, Be'er Sheva, 8410101, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, Petach Tikva, 4941492, Israel

RECRUITING

Ella Lemelbaum Institute for Immuno-Oncology and Melanoma

Ramat Gan, Ramat Gan, 5262100, Israel

RECRUITING

Tel Aviv Medical Center

Tel Aviv, Tel Aviv, 6423906, Israel

RECRUITING

Humanitas Gavazzeni Bergamo

Bergamo, Province of Bergamo, 24125, Italy

RECRUITING

Christchurch Public Hospital

Christchurch, Christchurch, 8011, New Zealand

RECRUITING

Auckland City Hospital

Auckland, New Zealand, 1023, New Zealand

RECRUITING

Nordland Hospital Trust

Bodø, Bodø, N-8005, Norway

RECRUITING

Oslo University Hospital - The Norwegian Radium Hospital

Oslo, Oslo County, 0310, Norway

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, Gdańsk, 80-952, Poland

RECRUITING

Prezychodnia Lekarska KOMED Roman Karaszewski

Konin, Konin, 62-500, Poland

RECRUITING

Mazowiecki Szpital Wojewódzki, Siedlckie Centrum Onkologii

Siedlce, Siedlce, 08-110, Poland

RECRUITING

Hospital da Luz Lisboa

Lisbon, Lisbon District, 1500-650, Portugal

RECRUITING

Military Medical Academy- Department of Oncology

Belgrade, Belgrade, 11000, Serbia

RECRUITING

Cancercare Port Elizabeth - Langenhoven Drive Oncology Centre

Port Elizabeth, Eastern Cape, 6045, South Africa

RECRUITING

University of Pretoria, Steve Biko Academic Hospital

Pretoria, Gauteng, 0002, South Africa

RECRUITING

The Medical Oncology Centre of Rosebank

Saxonwold, Gauteng, 2196, South Africa

RECRUITING

Cape Town Oncology Trials

Cape Town, Western Cape, 7570, South Africa

RECRUITING

TASK Eden

George Central, Western Cape, 6530, South Africa

RECRUITING

Hospital Universitari Dexeus

Barcelona, Barcelona, 08028, Spain

RECRUITING

Vall d' Hebron Institute of Oncology

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Galicia, 27003, Spain

RECRUITING

Institut Català d'Oncologia Girona (ICO Girona)

Girona, Girona, 17007, Spain

RECRUITING

University Hospital of Jerez

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

RECRUITING

GenesisCare Madrid - Hospital San Francisco de Asís

Madrid, Madrid, 28002, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Hospital 12 de Octubre

Usera, Madrid, 28031, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain

RECRUITING

IVO - Fundacion Instituto Valenciano de Oncologia

Valencia, Valencia, 46009, Spain

RECRUITING

INCLIVA Instituto de Investigación Sanitaria

Valencia, Valencia, 46010, Spain

RECRUITING

Gävle Sjukhus

Gävle, Gävleborg County, 801 88, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Södermanland County, 17176, Sweden

RECRUITING

Universitätsspital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Kantonsspital Graubünden

Chur, Chur, 7000, Switzerland

RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, England, SE1 9RT, United Kingdom

RECRUITING

Sarah Cannon Research Institute London

London, England, W1G6AD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Etah Kurland

  Eikon Therapeutics

  STUDY DIRECTOR

• Muaz Sadeia

  Eikon Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Krishna Kaza

CONTACT

+1 (516) 675-6163; Kazak@eikontx.com

Juliette Beaulieu

CONTACT

415-940-4170; beaulieuj@eikontx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: May 22, 2025
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2040
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

CH (2); SE (1); AU (4); CA (1); CZ (2); NO (2); FI (3); IT (1); BE (5); DE (8); IL (4); PT (1); ES (11); DK (2); US (11); PL (3); ZA (5); NZ (2); GB (2); FR (4)