Trial intelligence / Profile preview

ABP 206 vs Nivolumab in metastatic melanoma

NCT06054555Phase 3

Key facts

Status: Active, not recruiting
Start: Nov 2023
Primary completion: Jan 2028
Countries: 31
Sponsor: Amgen
Modality: Intravenous therapy

Drugs: ABP 206
Conditions: melanoma

Overview

Phase 3, randomised, double-blind trial of ABP 206 in melanoma (2 arms), sponsored by Amgen. Primary endpoints: Objective Response Rate at 49 weeks, Progression-Free Survival at 105 weeks and 2 more. Started Nov 2023; status: active, not recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

ABP 206
Experimental biosimilar to nivolumab
Nivolumab
Active comparator (reference product OPDIVO)

Who it enrols

Treatment-naïve adults with unresectable or metastatic melanoma (excluding ocular melanoma), ECOG 0-1, with measurable disease per RECIST 1.1 and available tumor tissue for biomarker analysis. No prior systemic therapy for advanced disease or prior immune checkpoint inhibitors.

Endpoints

Primary

Objective Response Rate49 weeks
Progression-Free Survival105 weeks
Overall Survival105 weeks
Duration of Response105 weeks

Secondary

Treatment-Emergent Adverse Events105 weeks
Treatment-Emergent Serious Adverse Events105 weeks
Adverse Events of Interest105 weeks
Anti-Drug Antibodies105 weeks
Trough Serum Concentration105 weeks

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