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

RecruitingPhase 1Ages 18 Years - anyAllAlvotech Swiss AG
NCT07475572 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion 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 Exclusion Criteria: * 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.
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What it tests

  • AVT32-DRL_PB
  • Keytruda
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Where

1 site
Site number 07010
Kiev, Ukraine
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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