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New keytruda copycat tested in melanoma trial

NCT ID NCT06551064

Disease control Sponsor: Formycon AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether FYB206, a biosimilar (or copycat) of the cancer drug Keytruda, works similarly in the body. It involves 96 people with stage IIB/IIC or III melanoma that was completely removed by surgery. Participants receive either FYB206 or Keytruda, and researchers compare how the drug levels behave over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FYB206 (a biosimilar to pembrolizumab/Keytruda)
What this could lead to
If successful, FYB206 could offer a more affordable alternative to Keytruda for preventing melanoma recurrence after surgery.
What could go wrong
This is an early phase 1 trial focused on drug levels in the body, not yet on effectiveness. Biosimilars may not perform identically, and results may not guarantee long-term benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

96 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma (as classified by the American Joint Committee on Cancer \[AJCC\]'s Cancer Staging Manual, 8th Edition) who have undergone complete resection within 12 weeks before randomization. No evidence of past or current satellites or in-transit metastases. * Disease status for the post-surgery baseline assessment must be documented by full chest/abdomen/pelvis computed tomography (CT) and/or magnetic resonance imaging (MRI) with neck CT and/or MRI (for head and neck primaries) and must have completed a clinical examination after the informed consent form has been signed and before enrollment. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. * Caucasian adult patients ≥18 years of age on the day of signing the informed consent. Exclusion Criteria: * History of radiation therapy for melanoma before trial entry. Post-lymph node dissection radiotherapy is allowed; however, this should be completed at least 7 days before treatment starts. * Uveal or ocular melanoma. * Diagnosis of immunodeficiency or receiving long-term systemic steroid therapy (\>10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy ≤7 days before the first dose of IMP. * Received prior therapy with an anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) monoclonal antibody (eg, ipilimumab), anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or agent directed to another stimulatory or co-inhibitory T-cell receptor. * Received prior systemic anticancer therapy for melanoma.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma stage III Melanoma, stage II

Contacts and locations

Locations

  • Formycon Investigative Site

    Sarajevo, Bosnia and Herzegovina

  • Formycon Investigative Site

    Sofia, Bulgaria

  • Formycon Investigative Site

    Tartu, Estonia

  • Formycon Investigative Site

    Batumi, Georgia

  • Formycon Investigative Site

    Kutaisi, Georgia

  • Formycon Investigative Site

    Tbilisi, Georgia

  • Formycon Investigative Site

    Kaunas, Lithuania

  • Formycon Investigative Site

    Chisinau, Moldova

  • Formycon Investigative Site

    Skopje, North Macedonia

  • Formycon Investigative Site

    Krakow, Poland

  • Formycon Investigative Site

    Lodz, Poland

  • Formycon Investigative Site

    Bucharest, Romania

  • Formycon Investigative Site

    Cluj-Napoca, Romania

  • Formycon Investigative Site

    Belgrade, Serbia

  • Formycon Investigative Site

    Kragujevac, Serbia

  • Formycon Investigative Site

    Niš, Serbia

  • Formycon Investigative Site

    Kyiv, Ukraine

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