Clinical Trial

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

Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07475572
Lead Sponsor Alvotech Swiss AG
Collaborators: Dr. Reddy's Laboratories Limited
Conditions Melanoma
Enrollment 120 participants
Start Date 2026-06-19
Primary Completion 2027-10 (estimated)
Study Completion 2028-04-14 (estimated)
Updated on ClinicalTrials.gov 2026-03-16