The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
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.
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.
Parallel
EIK1001
DrugEIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.
Pembrolizumab (KEYTRUDA® )
DrugPembrolizumab is a PD-1 inhibitor.
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.
Overall survival (OS)
Overall survival (OS) defined as the time from randomization to death due to any cause.
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).
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.
Adverse Events (AEs) and Discontinuation of study treatment due to any AE.
Adverse events (AEs), and discontinuation of study treatment due to any AE. 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.
Objective Response (OR)
Objective response (OR) is defined as the participants who demonstrate confirmed response (CR) or partial response (PR) according to RECIST 1.1 by BICR.
Duration of Response (DOR).
Duration of Response (DOR) is defined as the time from the first documented evidence of complete response (CR) or partial response (PR) until disease progression or death due to any cause, whichever occurs first according to RECIST 1.1 by BICR.
Progression Free Survival (PFS)
Progression Free Survival (PFS) according to RECIST 1.1 by Investigator.
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Eikon Therapeutics
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
