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

NCT06054555 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 633

Last updated 2026-01-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

ABP 206

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

DRUG

Nivolumab

Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-02
Primary Completion
2028-01-25
Completion
2028-01-25
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bosnia and Herzegovina
  • Canada
  • Chile
  • Croatia
  • Czechia
  • Estonia
  • France
  • Georgia
  • Germany
  • Italy
  • Jordan
  • Lebanon
  • Lithuania
  • Malaysia
  • Mexico
  • Moldova
  • Netherlands
  • Philippines
  • Portugal
  • Romania
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06054555 on ClinicalTrials.gov