Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma

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 tre

Trial Details

NCT ID

NCT07475572

Phase

PHASE1

Sponsor

Alvotech Swiss AG

Status

RECRUITING

Cancer Type

Melanoma

Interventions

• AVT32-DRL_PB
• Keytruda

Locations (sample)

• Kiev, Ukraine|50.45466,30.5238

Key Eligibility Criteria

• 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

For full eligibility, visit ClinicalTrials.gov.

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