> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-efficacy-of-eik1001-in-combo-with-pembro-versus-0e451399-dfd2-4047-bb65-213ca1e5713a > Record changed: 2026-11-04 # Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma. NCT06697301 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) Participants 740 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) Lead sponsor Eikon Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) Start date 2025-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) Number of sites 127 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) ## Title and summary **Summary** The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Short title** Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **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 (TeLuRide-006) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) ## Dates **Completion date** 2040-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **First posted** 2024-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Registry last updated** 2026-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Primary completion date** 2035-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Start date** 2025-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) ## Size and sites **Participants** 740 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Planned participants** 740 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Number of sites** 127 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Lead sponsor** Eikon Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) ## Identifiers **Registry ID** NCT06697301 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **ClinicalTrials.gov ID** NCT06697301 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) ## Outcomes ### Primary outcomes 1. Progression Free Survival (PFS) Timeframe: up to 5 years Progression-free survival (PFS) is defined as the time from the date of randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. 2. Overall survival (OS) Timeframe: up to 5 years Overall survival (OS) defined as the time from randomization to death due to any cause. 3. Objective Response (OR) (Dose Optimization Only) Timeframe: up to 5 years Objective Response (OR; defined as participants who demonstrate confirmed complete response \\\[CR\\\] or partial response \\\[PR\\\] by Response Evaluation Criteria in Solid Tumors \\\[RECIST\\\] version 1.1 as assessed by the Investigator) (Dose Optimization Only). 4. Adverse Events (AEs) (Dose Optimization Only) Timeframe: up to 2.5 years Adverse events (AEs), and discontinuation of study treatment due to an AE (Dose Optimization Only). An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. ### Secondary outcomes 1. Adverse Events (AEs) and Discontinuation of study treatment due to any AE. Timeframe: up to 2.5 years Adverse events (AEs), and discontinuation of study treatment due to any AE. An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 2. Objective Response (OR) Timeframe: up to 5 years Objective response (OR) is defined as the participants who demonstrate confirmed response (CR) or partial response (PR) according to RECIST 1.1 by BICR. 3. Duration of Response (DOR). Timeframe: up to 5 years Duration of Response (DOR) is defined as the time from the first documented evidence of complete response (CR) or partial response (PR) until disease progression or death due to any cause, whichever occurs first according to RECIST 1.1 by BICR. 4. Progression Free Survival (PFS) Timeframe: up to 5 years Progression Free Survival (PFS) according to RECIST 1.1 by Investigator. 5. Objective Response (OR) Timeframe: up to 5 years Objective Response (OR) according to RECIST 1.1 by Investigator. 6. Duration of Response (DOR) Timeframe: up to 5 years Duration of Response (DOR) according to RECIST 1.1 by Investigator 7. Duration of Response (DOR) (Dose Optimization Only). Timeframe: up to 5 years Duration of Response (DOR) per RECIST 1.1 by Investigator (Dose Optimization Only). 8. Progression-free survival (PFS) per RECIST 1.1 by Investigator (Dose Optimization Only). Timeframe: up to 5 years Progression-free survival (PFS) per RECIST 1.1 by Investigator (Dose Optimization Only). 9. Overall survival (OS) (Dose Optimization Only) Timeframe: up to 5 years Overall survival (OS) defined as the time from randomization to death due to any cause (Dose Optimization Only). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria To be eligible for inclusion in this study, participants must: - 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. ### Exclusion criteria A participant is excluded from the study if any of the following criteria apply: - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) ## Sites - Ironwood Cancer & Research CentersChandler, United StatesRecruiting - Genesis Cancer and Blood InstituteHot Springs, United StatesRecruiting - Helios Clinical ResearchLos Angeles, United StatesRecruiting - Providence Medical FoundationSanta Rosa, United StatesRecruiting - UCHealth Memorial Hospital CentralColorado Springs, United StatesRecruiting - Christiana CareNewark, United StatesRecruiting - Bioresearch PartnerHialeah, United StatesRecruiting - Florida Clinical Trials Group - TamaracTamarac, United StatesRecruiting - The Center for Cancer and Blood DisordersBethesda, United StatesRecruiting - MidAmerica Cancer CareKansas City, United StatesRecruiting - Washington University School of Medicine in St. LouisSt Louis, United StatesRecruiting - Gabrail Cancer Center Research LLCCanton, United StatesRecruiting - University of Pittsburgh Medical Center(UPMC)-Hillman Cancer CenterPittsburgh, United StatesRecruiting - Patientcare Clinical ResearchSugar Land, United StatesRecruiting - Cancer Care WollongongWollongong, AustraliaRecruiting - Icon Cancer Centre ChermsideChermside, AustraliaRecruiting - Southern Adelaide Local Health Network Incorporated Flinders Medical CentreBedford Park, AustraliaRecruiting - Eastern HealthBox Hill, AustraliaRecruiting - Peninsula and South Eastern Haematology and Oncology GroupFrankston, AustraliaRecruiting - Universitätsklinikum GrazGraz, AustriaRecruiting - Universitair Ziekenhuis AntwerpenEdegem, BelgiumRecruiting - Cliniques Universitaires Saint-LucBrussels, BelgiumRecruiting - Centre Hospitalier Universitaire Universite Catholique de Louvain - Site GodinneYvoir, BelgiumRecruiting - Universitair Ziekenhuis Leuven - Campus GasthuisbergLeuven, BelgiumRecruiting - Algemeen Ziekenhuis Groeninge - Campus KennedylaanKortrijk, BelgiumRecruiting And 102 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) ## References ### Other registry identifiers - KEYNOTE-G04 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06697301) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [Eikon Therapeutics](https://trialight.com/data/company/eikon-therapeutics-5efa5dce-6abb-40a6-980f-379653a8d862.md) ### Conditions (2) - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Primary condition - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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