NCT06697301 · Eikon Therapeutics
Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.
What this study is about
The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
View original scientific description
The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
Interventions
DRUG
EIK1001
EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.
DRUG
Pembrolizumab (KEYTRUDA® )
Pembrolizumab is a PD-1 inhibitor.
Primary outcome measures
Progression Free Survival (PFS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chandler, Arizona
- Hot Springs, Arkansas
- Los Angeles, California
- Santa Rosa, California
- Colorado Springs, Colorado
- Hialeah, Florida
- Bethesda, Maryland
- Kansas City, Missouri
- St Louis, Missouri
- Canton, Ohio
- Pittsburgh, Pennsylvania
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations