EIK1001 + Pembrolizumab for Skin Cancer

Recruiting at 79 trial locations

Overseen By Juliette Beaulieu

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Eikon Therapeutics

Must be taking: Pembrolizumab

Must not be taking: CYP3A4 inhibitors, CYP1A2 inducers

Disqualifiers: Ocular melanoma, Active CNS metastases, Autoimmune disease, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with advanced melanoma, a serious type of skin cancer. It aims to determine if adding an experimental drug, EIK1001, to the standard therapy, Pembrolizumab, can improve outcomes. Participants will be divided into groups: some will receive Pembrolizumab with a placebo, while others will receive Pembrolizumab with varying doses of EIK1001. The study seeks participants with advanced melanoma that cannot be surgically removed or has metastasized, and who are eligible for Pembrolizumab treatment. Those who have previously undergone melanoma treatments and whose condition has stabilized or worsened may be suitable for this trial. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in melanoma treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take medications that strongly affect certain liver enzymes (CYP3A4 and CYP1A2). If you're on such medications, you may need to stop them before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining EIK1001 with pembrolizumab is generally safe for patients. In studies involving various cancers, this combination produced mostly mild and manageable side effects. Specifically, one study found that 64% of lung cancer patients responded well to this treatment, indicating its effectiveness and lack of unexpected safety issues.

Pembrolizumab is already a common treatment for advanced melanoma, with a well-established safety profile. Based on these findings, the combination of EIK1001 and pembrolizumab appears safe, with side effects that are mostly manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about EIK1001 because it offers a novel approach to skin cancer treatment by potentially enhancing the effectiveness of Pembrolizumab, a common immunotherapy. Unlike traditional treatments that rely solely on Pembrolizumab to boost the immune system, EIK1001 is designed to target a different pathway, which could improve the immune response and lead to better outcomes. This combination might provide a more powerful attack against cancer cells, offering hope for improved efficacy and potentially fewer side effects compared to standard therapies.

What evidence suggests that this trial's treatments could be effective for advanced melanoma?

Research has shown that combining EIK1001 with pembrolizumab may effectively treat cancer. In this trial, participants in different arms will receive either EIK1001 at selected doses combined with pembrolizumab or a placebo with pembrolizumab. Studies have demonstrated that the combination of EIK1001 and pembrolizumab helped 64% of patients by shrinking or eliminating their tumors. EIK1001 is designed to strengthen the immune system, potentially enhancing its ability to fight tumors. It has been well-tolerated, with manageable side effects, across various types of cancer. Although most results come from other cancers, they suggest it could also work for advanced melanoma. ^{1 2 3 4 5}

Who Is on the Research Team?

Muaz Sadeia

Principal Investigator

Eikon Therapeutics

Etah Kurland

Principal Investigator

Eikon Therapeutics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS9604

TeLuRide-006: An adaptive phase 2/3 study of EIK1001, a ... While encouraging results have been observed with combinations of ICIs, no α-controlled, statistically significant OS benefit of combinations ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06697301

NCT06697301 | Safety and Efficacy of EIK1001 in Combo ... This is a Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and ...

3. onclive.com onclive.com/view/frontline-eik1001-plus-chemoimmunotherapy-stimulates-antitumor-activity-in-advanced-nsclc

Frontline EIK1001 Plus Chemoimmunotherapy Stimulates ... EIK1001 plus pembrolizumab and chemo showed a 64% ORR and manageable safety in first-line stage IV NSCLC, per phase 2 TeLuRide-005 data.

4. eikontx.com eikontx.com/news/eikon-therapeutics-to-present-new-phase-2-data-on-eik1001-in-first-line-non-small-cell-lung-cancer-at-esmo-2025/

Eikon Therapeutics to Present New Phase 2 Data ... “EIK1001 represents a unique approach to stimulating the immune system, and we are encouraged by its potential to improve outcomes for patients ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2521

Safety and preliminary efficacy of EIK1001 in combination ... Overall, EIK1001 was well-tolerated with a manageable safety profile and showed encouraging preliminary efficacy across several tumor types in combination with ...