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Taking peoplePhase 1

Comparing a proposed Keytruda biosimilar with Keytruda after melanoma surgery

Compares AVT32-DRL_PB with Keytruda in adults whose melanoma was fully removed.

Key facts

Who runs it
Alvotech Swiss AG
Where
Badalona, Barcelona, Cáceres, L'Hospitalet de Llobregat, Madrid, Málaga, Pozuelo de Alarcón, and Sevilla, SpainSee the 8 sitesAlso in 2 other countries, 5 sites
Registry title
Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma
Status
Recruiting
Phase
Phase 1
People taking part
120 people, planned
Started
10 Aug 2026
Expected to end
14 Apr 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • AVT32-DRL_PB
  • Keytruda
Record updated
24 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose melanoma skin cancer was fully removed by surgery and who need pembrolizumab afterwards. It compares a proposed biosimilar of Keytruda with Keytruda itself.

Age
18 years or older.
Sex
Men and women can join.
Disease stage
Stage IIB, IIC or III melanoma of the skin, confirmed by tissue examination, with the tumour fully removed by surgery.
Earlier treatment
People who had any earlier drug treatment for melanoma that works throughout the body, including trial drugs, cannot join.

Main reasons for not taking part

  • Had a solid organ transplant or a donor stem cell (bone marrow) transplant
  • Had earlier drug treatment for melanoma that works throughout the body, including trial drugs
  • History of melanoma of the mucous membranes or the eye (uveal), even if treated more than 5 years ago

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Spain

Also in 2 other countries, 5 sites

  • Institut Catala d'OncologiaBadalona, SpainNot yet recruiting
  • Hospital Universitari Vall d'HebronBarcelona, SpainNot yet recruiting
  • Hospital San Pedro De AlcántaraCáceres, SpainNot yet recruiting
  • Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainNot yet recruiting
  • Hospital Universitario 12 de OctubreMadrid, SpainNot yet recruiting
  • Hospital Quironsalud MalagaMálaga, SpainNot yet recruiting
  • Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainNot yet recruiting
  • Hospital Universitario Virgen De La MacarenaSevilla, SpainNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • AVT32-DRL_PBTreatment being tested

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

  • KeytrudaExisting treatment, for comparison

    Keytruda will be administered during double blind period

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official 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
Plain-language title
Comparing a proposed Keytruda biosimilar with Keytruda after melanoma surgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
24 August 2026