Recruiting

Phase 2

Phase 3

EIK1001-006 & PembroSafety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.

Sponsor:

Eikon Therapeutics

Code:

NCT06697301

Conditions

Advanced Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EIK1001

Pembrolizumab (KEYTRUDA® )

Study Details

Brief summary:

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

Conditions

Advanced Melanoma

Study ID

NCT06697301

Start date

May 22, 2025

Status verified date

May, 2026

Completion date

Dec, 2040

Anticipated

Primary completion date

Dec, 2035

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

740 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

EIK1001

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

Pembrolizumab (KEYTRUDA® )

Pembrolizumab is a PD-1 inhibitor.

Primary outcome measure

Progression Free Survival (PFS) [ Time Frame: up to 5 years ]
Overall survival (OS) [ Time Frame: up to 5 years ]
Objective Response (OR) (Dose Optimization Only) [ Time Frame: up to 5 years ]
Adverse Events (AEs) (Dose Optimization Only) [ Time Frame: up to 2.5 years ]

Central Contacts and Locations

Central contacts

Krishna Kaza, Director Clinical Study Management

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

Locations

Ironwood Cancer & Research Centers

Recruiting

Chandler, Arizona, United States, 85224

Contacts

Tiffany Wales

480-256-1372 TIffany.Walas@ironwoodcrc.com

Principal Investigator:

Amikar Sehdev, MD

Genesis Cancer and Blood Institute

Recruiting

Hot Springs, Arkansas, United States, 71913

Contacts

Laura Sellers

5016247700 Laura.Sellers@aoncology.com

Principal Investigator:

Robert Muldoon

Helios Clinical Research

Recruiting

Los Angeles, California, United States, 90015

Contacts

Sabrina Mora

562-735-3226 Sabrinamora@theoncologyinstitute.com

Leslie Posadas

leslieposadas@theoncologyinstitute.com

Principal Investigator:

Pamela Miel

Providence Medical Foundation

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Linda Gozar

+1 714-992-3000 Linda.Gozar@stjoe.org

Principal Investigator:

David Park

UCHealth Memorial Hospital Central

Recruiting

Colorado Springs, Colorado, United States, 80909

Contacts

Ashley Miller

719-365-5062 ashley.miller5@uchealth.org

Principal Investigator:

Stacey ParkerBrueggemann, MD

Christiana Care

Recruiting

Newark, Delaware, United States, 19713

Contacts

Jennifer Knotts

302- 623-4889 JKnotts@christianacare.org

Julie Falango

Julie.falango@christianacare.org

Principal Investigator:

Jamal Misleh

Bioresearch Partner

Recruiting

Hialeah, Florida, United States, 33013

Contacts

Tahimi Campa

833-489-4968 tdelacampa@bioresearchpartner.com

Mabel Cruz

833-489-4968 mcruz@bioresearchpartner.com

Principal Investigator:

Luis Rangel

Florida Clinical Trials Group - Tamarac

Recruiting

Tamarac, Florida, United States, 33321

Contacts

Maria Abreu

(772) 297-3057 abreum@floridactg.com

Mairan Rivera

772-297-3057 riveram@floridactg.com

Principal Investigator:

Chintan Gandhi

The Center for Cancer and Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Taylor Stutzman

301-571-2016 taylor.stutzman@aoncology.com

Principal Investigator:

Victor Priego

MidAmerica Cancer Care

Recruiting

Kansas City, Missouri, United States, 64132

Contacts

Logan Marney

833-886-1725 Logan.Marney@aoncology.com

Principal Investigator:

Jaswinder Singh

Washington University School of Medicine in St. Louis

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Kelsey Etter

314-273-0656 etter@wustl.edu

Principal Investigator:

George Ansstas

Gabrail Cancer Center Research LLC

Recruiting

Canton, Ohio, United States, 44718

Contacts

Carrie Smith

330-417-8231 csmith@gabrailcancercenter.com

Principal Investigator:

Nashat Gabrail

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

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Danielle Bednarz

412 623-1191 bednarzdl@upmc.edu

Principal Investigator:

Diwakar Davar, MD

Patientcare Clinical Research

Recruiting

Sugar Land, Texas, United States, 77479

Contacts

Muhammad Muzammil

1 (732) 358-3048 muzammil@patientcareclinicalresearch.com

Principal Investigator:

Amir Rasheed

Sunnybrook Research Ins<tute

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Stephanie Lewaniak

+1 416-480-5000 stephanie.lewaniak@sunnybrook.ca

Carolyn Lim

+1 416-480-5000 carolyn.lim@sunnybrook.ca

Principal Investigator:

Rossanna Pezo

More Information

Sponsor

Eikon Therapeutics

Last update posted

Oct 6, 2026

Last verified

May, 2026

Keywords

Metastatic
Advanced

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Eikon Therapeutics on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.