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

NCT07475572 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: AVT32-DRL-TPK-02
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

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

  AUC0-3w (Cycle 1)

  Cycle 1 (each cycle is 21 days)

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

  AUCtau,ss (Cycle 6)

  Cycle 6 (each cycle is 21 days)

Study Arms (2)

AVT32-DRL_PB

EXPERIMENTAL

AVT32-DRL\_PB will be administered during double blind period and open label period

Biological: AVT32-DRL_PB

Keytruda

ACTIVE COMPARATOR

Keytruda will be administered during double blind period

Biological: Keytruda

Interventions

AVT32-DRL_PB BIOLOGICAL

AVT32-DRL\_PB at a dose 200 mg administered intravenously every 3 weeks.

AVT32-DRL_PB

Keytruda BIOLOGICAL

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

Keytruda

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alvotech Swiss AG: lead
• Dr. Reddy's Laboratories Limited: collaborator

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Clinical Development Lead

CONTACT

+41 78 659 8989; alvotech.clinical@alvotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 16, 2026
• Study Start (Estimated): June 19, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 14, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share