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EIK1001 and Pembrolizumab for Advanced Melanoma

This study is for people with advanced melanoma that cannot be removed by surgery (unresectable Stage 3) or has spread to other parts of the body (Stage 4 metastatic melanoma). It's testing a new combination of treatments: EIK1001, which is a Toll-like receptor 7/8 (TLR 7/8) dual agonist, with pembrolizumab (KEYTRUDA®), a standard treatment that helps your immune system fight cancer. Researchers want to see if adding EIK1001 to pembrolizumab is safe and effective as a first treatment. The study will measure how long people live without their cancer getting worse (Progression Free Survival), how long they live overall (Overall Survival), and if their tumors shrink (Objective Response). You must be at least 18 years old and eligible for standard pembrolizumab treatment to join. The study plans to enroll 740 participants, but its current recruitment status is unclear.

Study design
This is a multi-center, randomized, double-blind study, meaning participants are assigned to treatment groups by chance, and neither you nor your doctor will know which treatment you are receiving. It compares EIK1001 plus pembrolizumab to a placebo (an inactive substance) plus pembrolizumab. The study is adaptive, with dose optimization and expansion parts, and plans to enroll 740 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Progression Free Survival, Overall Survival, and Objective Response for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06697301

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Eikon Therapeutics
~740 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:EIK1001Pembrolizumab (KEYTRUDA® )

At a glance

Recruiting sites
107 of 107 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over up to 5 years
+3 more outcomes measured

Conditions

Advanced Melanoma

Explore related trials

MelanomaBRAF Gene

Where it's being run

107 sites across 93 states
Madrid4
California2
Missouri2
Victoria2
Baden-Wurttemberg2
Schleswig-Holstein2
Lisbon District2
Gauteng2

Study leadership

  • Etah Kurland · STUDY_DIRECTOR · Eikon Therapeutics
  • Muaz Sadeia · STUDY_DIRECTOR · Eikon Therapeutics

Who to contact

Krishna Kaza
[email protected]
+1 (516) 675-6163
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression Free Survival (PFS)up to 5 years

    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.

  • Overall survival (OS)up to 5 years

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

  • Objective Response (OR) (Dose Optimization Only)up to 5 years

    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).

  • Adverse Events (AEs) (Dose Optimization Only)up to 2.5 years

    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.