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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Eikon Therapeutics
Study ID
NCT06697301
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Advanced Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EIK1001 — DRUG
    EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.
  • Pembrolizumab (KEYTRUDA® ) — DRUG
    Pembrolizumab is a PD-1 inhibitor.

Study Details

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

Key Dates

Start date
May 22, 2025
Status verified
May 2026
Primary completion
Dec 31, 2035
Completion
Dec 31, 2040

Study Design

Enrollment
740 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1
    Participants in this arm will receive Placebo and Standard of Care (Pembrolizumab).
  • Experimental: Arm 2
    Participants in this arm will receive EIK1001 (selected dose 1) + Standard of Care (Pembrolizumab).
  • Experimental: Arm 3
    Participants in this arm will receive EIK1001 (selected dose 2) + Standard of Care (Pembrolizumab).

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: up to 5 years ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Ironwood Cancer & Research CentersChandlerArizona85224
Tiffany Wales
[email protected]
480-256-1372
Amikar Sehdev, MD (PRINCIPAL_INVESTIGATOR)
Genesis Cancer and Blood InstituteHot SpringsArkansas71913
Laura Sellers
[email protected]
5016247700
Robert Muldoon (PRINCIPAL_INVESTIGATOR)
Helios Clinical ResearchLos AngelesCalifornia90015
Sabrina Mora
[email protected]
562-735-3226
Leslie Posadas
[email protected]
Pamela Miel (PRINCIPAL_INVESTIGATOR)
Providence Medical FoundationSanta RosaCalifornia95403
Linda Gozar
[email protected]
+1 714-992-3000
David Park (PRINCIPAL_INVESTIGATOR)
Natalie Valle (SUB_INVESTIGATOR)
UCHealth Memorial Hospital CentralColorado SpringsColorado80909
Ashley Miller
[email protected]
719-365-5062
Stacey ParkerBrueggemann, MD (PRINCIPAL_INVESTIGATOR)
Bioresearch PartnerHialeahFlorida33013
Tahimi Campa
[email protected]
833-489-4968
Mabel Cruz
[email protected]
833-489-4968
Luis Rangel (PRINCIPAL_INVESTIGATOR)
The Center for Cancer and Blood DisordersBethesdaMaryland20817
Taylor Stutzman
[email protected]
301-571-2016
Victor Priego (PRINCIPAL_INVESTIGATOR)
MidAmerica Cancer CareKansas CityMissouri64132
Logan Marney
[email protected]
833-886-1725
Jaswinder Singh (PRINCIPAL_INVESTIGATOR)
Washington University School of Medicine in St. LouisSt LouisMissouri63108
Kelsey Etter
[email protected]
314-273-0656
George Ansstas (PRINCIPAL_INVESTIGATOR)
Nicole Chrisman (SUB_INVESTIGATOR)
Gabrail Cancer Center Research LLCCantonOhio44718
Carrie Smith
[email protected]
330-417-8231
Nashat Gabrail (PRINCIPAL_INVESTIGATOR)
Carmen Baldwin (SUB_INVESTIGATOR)
University of Pittsburgh Medical Center(UPMC)-Hillman Cancer CenterPittsburghPennsylvania15232
Danielle Bednarz
[email protected]
412 623-1191
Diwakar Davar, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chandler, AZ

By research site
Ironwood Cancer & Research Centers· Chandler, AZGenesis Cancer and Blood Institute· Hot Springs, ARHelios Clinical Research· Los Angeles, CAProvidence Medical Foundation· Santa Rosa, CAUCHealth Memorial Hospital Central· Colorado Springs, COBioresearch Partner· Hialeah, FL

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