Trial intelligence / Profile preview

Fianlimab + Cemiplimab vs Pembrolizumab in Advanced Melanoma

NCT05352672Phase 3

Key facts

Status: Active, not recruiting
Start: Jul 2022
Primary completion: Mar 2026
Countries: 24
Sponsor: Regeneron Pharmaceuticals
Modality: Immune Checkpoint Inhibitors

Drugs: fianlimab
Conditions: melanoma

Overview

Phase 3, randomised, double-blind trial of fianlimab in melanoma (4 arms), sponsored by Regeneron Pharmaceuticals. Primary endpoint: Progression-Free Survival at 27 months. Started Jul 2022; status: active, not recruiting.

Design

4 arms

Study design: RandomizedDouble-blind

fianlimab+cemiplimab dose 1
Fianlimab + Cemiplimab dose 1 via IV infusion
fianlimab+cemiplimab dose 2
Fianlimab + Cemiplimab dose 2 via IV infusion
pembrolizumab+placebo
Pembrolizumab + Placebo via IV infusion
cemiplimab+placebo
Cemiplimab + Placebo via IV infusion

Who it enrols

Patients >=12 years with previously untreated unresectable Stage III or IV melanoma, measurable disease, good performance status, and no active autoimmune disease or uncontrolled infections.

Endpoints

Primary

Progression-Free Survival27 months

Secondary

Overall Survival96 months
Objective Response Rate27 months
Disease Control Rate27 months
Duration of Response27 months
Adverse Events6 years
Pharmacokinetics6 years
Anti-Drug Antibodies6 years
Patient-Reported Outcomes6 years

Results

Not all primary endpoints met

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