A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

Part of paid clinical trials in Long Beach, California.

Sponsor
Amgen
Study ID
NCT06054555
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • ABP 206 — DRUG
    ABP 206 will be given intravenously over a period of 30 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.
  • Nivolumab — DRUG
    Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.

Study Details

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

Key Dates

Start date
Nov 2, 2023
Status verified
Jan 2026
Primary completion
Jan 25, 2028
Completion
Jan 25, 2028

Study Design

Enrollment
633 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ABP 206
    Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
  • Active Comparator: Nivolumab
    Subjects will receive Dose A of Nivolumab via IV infusion.

Primary Outcome Measure

Objective response by Week 49 [ Time Frame: Week 49 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Cancer and Blood Specialty clinicLong BeachCalifornia90806-
Fort Wayne Medical Oncology and Hematology - Office of Clinical ResearchFort WayneIndiana46825-
Our Lady of the Lake Physicians Group-Medical Oncology-Woman's PavilionBaton RougeLouisiana70809-
Oncology Hematology AssociatesSpringfieldMissouri65807-5287-
Hematology-Oncology Associates of Central New York, P.C. (HOA) - East Syracuse - CCOPEast SyracuseNew York13057-

Find similar trials in Long Beach, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Cancer and Blood Specialty clinic· Long Beach, CAFort Wayne Medical Oncology and Hematology - Office of Clinical Research· Fort Wayne, INOur Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion· Baton Rouge, LAOncology Hematology Associates· Springfield, MOHematology-Oncology Associates of Central New York, P.C. (HOA) - East Syracuse - CCOP· East Syracuse, NY

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