Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Thera… (NCT06697301) | Clinical Trial Compass
RecruitingPhase 2/3
Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.
United States740 participantsStarted 2025-05-22
Plain-language summary
The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
Who can participate
Age range18 Years
SexALL
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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 \…