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A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma - Trial NCT06054555

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.

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NCT06054555
Phase 3
Recruiting
drug
Trial Details
ClinicalTrials.govNCT06054555
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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

Study Focus

Melanoma

ABP 206

Interventional

drug

Sponsor & Location

Amgen

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 3

Nov 02, 2023

Jan 25, 2027

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 skin
Melanoma in situ, unspecified
Melanoma in situ
Melanoma and other malignant neoplasms of skin
Malignant neoplasm: Malignant melanoma of skin, unspecified

Data Source

ClinicalTrials.gov

NCT06054555

Non-Device Trial