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NCT Number: NCT07475572

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 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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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site number 07010

Kiev, Ukraine

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AVT32-DRL_PB

Biological

AVT32-DRL_PB at a dose 200 mg administered intravenously every 3 weeks.

Keytruda

Biological

Keytruda at a dose 200 mg administered intravenously every 3 weeks.

Primary outcomes

  1. To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)

    Time frame: Cycle 1 (each cycle is 21 days)

    AUC0-3w (Cycle 1)

  2. To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)

    Time frame: Cycle 6 (each cycle is 21 days)

    AUCtau,ss (Cycle 6)

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Development Lead

CONTACT

[email protected]

+41 78 659 8989

Sponsors and collaborators

Lead sponsor

Alvotech Swiss AG

Industry

Collaborators

  • Dr. Reddy's Laboratories Limited

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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