EIK1001 + Pembrolizumab for Skin Cancer

Recruiting at 11 trial locations

Overseen By Surya Vangala

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Eikon Therapeutics

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: up to 2.5 years

740 Participants Needed

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.

Research Team

Etah Kurland

Principal Investigator

Eikon Therapeutics

Wale Akinseli

Principal Investigator

Eikon Therapeutics

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

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])

I agree to use birth control or abstain from sex during the study.

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.

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

Treatment Details

Interventions

• EIK1001
• Pembrolizumab

Trial Overview 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.

Participant Groups

Group I: Arm 3 Experimental Treatment 2 Interventions

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

Group II: Arm 2 Experimental Treatment 2 Interventions

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

Group III: Arm 1 Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Eikon Therapeutics

Lead Sponsor

Trials

8

Recruited

1,300+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University