NCT07475572

A Randomized, Double-Blind, Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma

A Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytruda® as an Adjuvant Treatment in Participants With Stage IIB/C-III Melanoma Following Complete Resection

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, parallel-group, 2 treatment group, repeated dose study to compare the PK, efficacy, safety, and immunogenicity of AVT32-DRL\_PB (proposed Keytruda® biosimilar) versus Keytruda (pembrolizumab) when administered as monotherapy in participants with fully resected Stage IIB/C or Stage III melanoma requiring adjuvant treatment with pembrolizumab. Eligible participants will be randomized in a 1:1 ratio to the AVT32-DRL\_PB or Keytruda treatment group and stratified by sex (female versus male) and body weight category (≤75 kg versus \>75 kg). Study treatments will be administered every 3 weeks (Q3W) as an intravenous (IV) infusion over 30 minutes (1 administration Q3W is 1 treatment cycle). The administered pembrolizumab dose will be 200 mg Q3W for both treatment groups.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	AVT32-DRL_PB	AVT32-DRL\_PB at a dose 200 mg administered intravenously every 3 weeks.
BIOLOGICAL	Keytruda	Keytruda at a dose 200 mg administered intravenously every 3 weeks.

Timeline

• Start date: 2026-06-19
• Primary completion: 2027-10-01
• Completion: 2028-04-14
• First posted: 2026-03-16
• Last updated: 2026-03-16