A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma

Part of paid clinical trials in Long Beach, California.

Sponsor
Amgen
Study ID
NCT05907122
Phase
PHASE3
Status
Completed

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 minutes, every 4 weeks (Q4W) for a total of 12 months.
  • FDA-licensed Nivolumab — DRUG
    FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
  • EU-authorized Nivolumab — DRUG
    FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.

Study Details

The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.

Key Dates

Start date
Jul 26, 2023
Status verified
Mar 2026
Primary completion
Mar 26, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
256 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: FDA-licensed Nivolumab
    Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.
  • Active Comparator: EU-authorized Nivolumab
    Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion.

Primary Outcome Measure

Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d) [ Time Frame: Day 1 (Postdose) through Day 28 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Cancer and Blood Specialty clinicLong BeachCalifornia90806-
St. Vincent Frontier Cancer Center - OncologyBillingsMontana59102-6746-

Related coverage on Hipa.ai

Find similar trials in Long Beach, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Cancer and Blood Specialty clinic· Long Beach, CASt. Vincent Frontier Cancer Center - Oncology· Billings, MT

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