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

March 11, 2026 updated by: Alvotech Swiss AG

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AVT32-DRL_PB
AVT32-DRL_PB will be administered during double blind period and open label period
Biological: AVT32-DRL_PB
AVT32-DRL_PB at a dose 200 mg administered intravenously every 3 weeks.
Active Comparator: Keytruda
Keytruda will be administered during double blind period
Biological: Keytruda
Keytruda at a dose 200 mg administered intravenously every 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
Time Frame: Cycle 1 (each cycle is 21 days)
AUC0-3w (Cycle 1)
Cycle 1 (each cycle is 21 days)
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
Time Frame: Cycle 6 (each cycle is 21 days)
AUCtau,ss (Cycle 6)
Cycle 6 (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvotech Swiss AG

Collaborators

Dr. Reddy's Laboratories Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 19, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

April 14, 2028

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVT32-DRL-TPK-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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