RECRUITING

Safety and Efficacy of EIK1001-006 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.

Official Title

A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants With Advanced Melanoma.

Quick Facts

Study Start:2025-04

Study Completion:2040-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06697301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 \> 2 years, post-hysterectomy/oophorectomy, or surgically sterilized). * Agree to use an approved adequate contraceptive method throughout the study (Visit 1 to 120 days after the last dose of study therapy; applies to sexually active male participants with a partner who is WOCBP). * Be willing and able to provide written, informed consent for the study.	* Has melanoma of ocular origin. * 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. * Prior to the 1St dose of EIK1001 or placebo, the prospective participant has received systemic therapy for advanced melanoma. * Note: 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. * Experienced a ≥ Grade 3 AE while receiving prior anti PD 1 therapy. * Has had major surgery (\< 3 weeks prior to the first dose). * Has received a live-virus vaccination within 30 days of the first dose of study treatment. * Has a known history of prior malignancy, unless the participant has undergone potentially curative therapy with no evidence of disease recurrence for 5 years. * Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate if they are clinically stable for at least 4 weeks with no evidence of new or enlarging brain metastases. There must be no need for immunosuppressive doses of glucocorticoids for at least 2 weeks prior to study treatment administration. * There is a mean resting QTcF \> 470 ms on triplicate electrocardiograms. * There is active autoimmune disease that has required systemic treatment in the past 2 years. The following autoimmune conditions are permitted: Type 1 diabetes, hypothyroidism (on hormone replacement), or- vitiligo, psoriasis and alopecia as long as no systemic treatment is required. * There is either chronic treatment with systemic steroids, other immunosuppressive medication, or either of these has been administered within 14 days of start of study treatment. * Note: Participants with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections are eligible. Steroid replacement for adrenal insufficiency is also permitted. * There is a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/ interstitial lung disease. * There are any active infections requiring therapy. * There is uncontrolled human immunodeficiency virus (HIV) infection. HIV-infected participants with well-controlled HIV may enroll. * There is a positive test result for hepatitis B virus (HBV) or HCV indicating presence of virus (it is expected that all participants will have been serologically tested for hepatitis B in advance of this study, with HBsAG, anti-HBc IgG, and anti-HBs as per ASCO 2020 Provisional Clinical Opinion \[PCO\] on universal Serologic testing for hepatitis B at the onset of anticancer therapy; screening should also include an anti-HCV test prior to start of cancer treatment: * There is a history or clinical evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study or interfere with the participant's participation for the full duration of the study * Known psychiatric or substance abuse disorder that would interfere with cooperation with study requirements. * There is a known history of regular illicit drug use and/or recent history (within the last year) of substance abuse (including alcohol). * Participant is pregnant, breastfeeding, or planning to conceive or father children within the projected duration of the study. * Participant is currently receiving medications known to be strong inhibitors or inducers of CYP3A4 and CYP1A2.

Inclusion Criteria

Exclusion Criteria

* 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 \> 2 years, post-hysterectomy/oophorectomy, or surgically sterilized).
* Agree to use an approved adequate contraceptive method throughout the study (Visit 1 to 120 days after the last dose of study therapy; applies to sexually active male participants with a partner who is WOCBP).
* Be willing and able to provide written, informed consent for the study.

* Has melanoma of ocular origin.
* 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.
* Prior to the 1St dose of EIK1001 or placebo, the prospective participant has received systemic therapy for advanced melanoma.
* Note: 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.
* Experienced a ≥ Grade 3 AE while receiving prior anti PD 1 therapy.
* Has had major surgery (\< 3 weeks prior to the first dose).
* Has received a live-virus vaccination within 30 days of the first dose of study treatment.
* Has a known history of prior malignancy, unless the participant has undergone potentially curative therapy with no evidence of disease recurrence for 5 years.
* Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate if they are clinically stable for at least 4 weeks with no evidence of new or enlarging brain metastases. There must be no need for immunosuppressive doses of glucocorticoids for at least 2 weeks prior to study treatment administration.
* There is a mean resting QTcF \> 470 ms on triplicate electrocardiograms.
* There is active autoimmune disease that has required systemic treatment in the past 2 years. The following autoimmune conditions are permitted: Type 1 diabetes, hypothyroidism (on hormone replacement), or- vitiligo, psoriasis and alopecia as long as no systemic treatment is required.
* There is either chronic treatment with systemic steroids, other immunosuppressive medication, or either of these has been administered within 14 days of start of study treatment.
* Note: Participants with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections are eligible. Steroid replacement for adrenal insufficiency is also permitted.
* There is a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/ interstitial lung disease.
* There are any active infections requiring therapy.
* There is uncontrolled human immunodeficiency virus (HIV) infection. HIV-infected participants with well-controlled HIV may enroll.
* There is a positive test result for hepatitis B virus (HBV) or HCV indicating presence of virus (it is expected that all participants will have been serologically tested for hepatitis B in advance of this study, with HBsAG, anti-HBc IgG, and anti-HBs as per ASCO 2020 Provisional Clinical Opinion \[PCO\] on universal Serologic testing for hepatitis B at the onset of anticancer therapy; screening should also include an anti-HCV test prior to start of cancer treatment:
* There is a history or clinical evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study or interfere with the participant's participation for the full duration of the study
* Known psychiatric or substance abuse disorder that would interfere with cooperation with study requirements.
* There is a known history of regular illicit drug use and/or recent history (within the last year) of substance abuse (including alcohol).
* Participant is pregnant, breastfeeding, or planning to conceive or father children within the projected duration of the study.
* Participant is currently receiving medications known to be strong inhibitors or inducers of CYP3A4 and CYP1A2.

Contacts and Locations

Study Contact

Krishna Kaza

CONTACT

516-675-6163

Kazak@eikontx.com

Surya Vangala

CONTACT

341-777-0445

vangalas@eikontx.com

Principal Investigator

Etah Kurland

STUDY_DIRECTOR

Eikon Therapeutics

Wale Akinseli

STUDY_DIRECTOR

Eikon Therapeutics

Study Locations (Sites)

Ironwood Cancer & Research Centers

Chandler, Arizona, 85224

United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909

United States

University of Pittsburgh Medical Center(UPMC)-Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Collaborators and Investigators

Sponsor: Eikon Therapeutics

Etah Kurland, STUDY_DIRECTOR, Eikon Therapeutics
Wale Akinseli, STUDY_DIRECTOR, Eikon Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04

Study Completion Date2040-12

Study Record Updates

Study Start Date2025-04

Study Completion Date2040-12

Terms related to this study

Keywords Provided by Researchers

Metastatic
Advanced

Additional Relevant MeSH Terms

Advanced Melanoma