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NCT06054555Recruiting

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

A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma
AmgenPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Melanoma
Drug/Device/Intervention
ABP 206
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Amgen
Location
Fort Wayne,Springfield,Fredericton,Tbilisi,Tbilisi,Tbilisi,Tbilisi,Vilnius,Sevilla,El Palmar,Málaga,Sevilla,Valencia, Canada,Georgia,Lithuania,Spain,United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Nov 02, 2023
End date
Jan 25, 2027
Enrollment
620 participants
Primary outcome

Objective response by Week 49,Objective response at Week 17,Progression-free survival (PFS),Overall survival (OS),Duration of response (DOR)

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.

ICD-10 classifications
Malignant melanoma of skinMelanoma in situ, unspecifiedMelanoma in situMelanoma and other malignant neoplasms of skinMalignant neoplasm: Malignant melanoma of skin, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06054555
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06054555 through Pure Global AI's free database. This Phase 3 trial is sponsored by Amgen and is currently Recruiting. The study focuses on Melanoma. Target enrollment is 620 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.