Comparing a proposed Keytruda biosimilar with Keytruda after melanoma surgery
Compares AVT32-DRL_PB with Keytruda in adults whose melanoma was fully removed.
Plain-language title generated from the registry record
Registry title: Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma
Key facts
- Where
- Bucharest, Cluj-Napoca, and Craiova, RomaniaSee the 4 sites
- Phase
- Phase 1
Where in Romania
- Futuremeds S.R.L.Bucharest, RomaniaTaking people
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu BucurestiBucharest, RomaniaTaking people
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-NapocaCluj-Napoca, RomaniaTaking people
- Centrul De Oncologie SF Nectarie S.R.L.Craiova, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alvotech Swiss AG
- Trial code
- NCT07475572EU 2025-525093-11-00
- Record updated
- 24 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Participants (male/female) ≥18 years of age at the time of signing the ICF; Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment; Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma.
Exclusion: Have had a solid organ transplant or bone marrow (stem cell) transplant that used donor stem cells (allogenic); Has received prior systemic anticancer therapy for melanoma including investigational agents; Participants with a history of mucosal or uveal melanoma, even if diagnosis and treatment were completed >5 years ago.