EIK1001 + Pembrolizumab for Skin Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Eikon Therapeutics

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.

Eligibility Criteria

Adults over 18 with advanced melanoma, eligible for Pembrolizumab therapy, can join this trial. They should have a life expectancy of at least 3 months and measurable disease by CT/MRI. Participants need known BRAF V600 mutation status, completed radiotherapy 2 weeks prior, good performance status (ECOG 0-1), and proper organ/marrow function. Women must test negative for pregnancy and agree to use contraception.

Inclusion Criteria

I am 18 years old or older.

Have a life expectancy of at least 3 months

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])

+9 more

Exclusion Criteria

I had a severe reaction to previous anti PD-1 therapy.

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

My melanoma originates from the eye.

+17 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EIK1001 and Pembrolizumab or Placebo and Pembrolizumab as first-line therapy for advanced melanoma

up to 2.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 5 years

Participant Groups

The trial is testing the safety and effectiveness of EIK1001 combined with Pembrolizumab versus a placebo plus Pembrolizumab in treating patients with advanced melanoma as their first line of therapy.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 3Experimental Treatment2 Interventions

Participants in this arm will receive EIK1001 (selected dose 2) + Standard of Care (Pembrolizumab).

Group II: Arm 2Experimental Treatment2 Interventions

Participants in this arm will receive EIK1001 (selected dose 1) + Standard of Care (Pembrolizumab).

Group III: Arm 1Active Control1 Intervention

Participants in this arm will receive Placebo and Standard of Care (Pembrolizumab).