OncoMatch/Clinical Trials/NCT06697301
Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.
Is NCT06697301 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including EIK1001 and Pembrolizumab (KEYTRUDA® ) for advanced melanoma.
Treatment: EIK1001 · Pembrolizumab (KEYTRUDA® ) — The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Allowed: BRAF V600 mutation
Have known BRAF V600 mutation status or consent to BRAF V600 mutation testing per local institutional standards during the screening period
Disease stage
Required: Stage 3 (UNRESECTABLE), IV (AJCC 8th ed.)
Metastatic disease required
histologically or cytologically confirmed Stage 3 (unresectable) or Stage 4 metastatic melanoma per AJCC 8th ed.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: 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
Prior to the 1St dose of EIK1001 or placebo, the prospective participant has received systemic therapy for advanced melanoma.
Lab requirements
Blood counts
adequate CBC, coagulation on specimens collected within 10 days of treatment start
Kidney function
adequate serum chemistry on specimens collected within 10 days of treatment start
Liver function
adequate liver function tests on specimens collected within 10 days of treatment start
Cardiac function
mean resting QTcF > 470 ms on triplicate electrocardiograms [excluded]
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. There is a mean resting QTcF > 470 ms on triplicate electrocardiograms.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ironwood Cancer & Research Centers · Chandler, Arizona
- Genesis Cancer and Blood Institute · Hot Springs, Arkansas
- Helios Clinical Research · Los Angeles, California
- Providence Medical Foundation · Santa Rosa, California
- UCHealth Memorial Hospital Central · Colorado Springs, Colorado
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
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