Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients (Dahlia)

August 27, 2025 updated by: Formycon AG

A Randomized, Double-Blind, Multicenter, Pharmacokinetic Equivalence Clinical Trial of Adjuvant FYB206 (Keytruda Biosimilar Candidate) in Comparison With Keytruda (Pembrolizumab) to Demonstrate Pharmacokinetic Similarity in Patients With Completely Resected Stage IIB/IIC or Stage III Melanoma

Melanoma is a kind of skin cancer that starts in the melanocytes. Melanocytes are cells that make the pigment that gives skin its colour. 'Resected' means the melanoma has been completely removed with surgery.

Pembrolizumab is an anti-cancer therapy that works with the immune system to fight cancer cells. Some cancer cells develop a way to hide from the body's immune system and, thus, allow the cancer cells to spread and grow. Pembrolizumab helps the immune system recognize and kill these cancer cells that want to hide.

Pembrolizumab is a biologic drug (produced by living organisms) available in the market under the brand name Keytruda. Keytruda is approved globally for the treatment of a variety of cancers and as an addon or after therapy to primary cancer treatment like surgery. This helps prevent the cancer from returning, improving overall survival.

FYB206 is a proposed biosimilar to Keytruda. A biosimilar is not identical but very similar to its original biologic. Biosimilars are expected to have a similar effect and safety to the original biologic. To learn what happens to a drug once it is in the body is called pharmacokinetics (PK). PK for biosimilar drugs is expected to remain similar to the original biologic. This study is to show that PK of FYB206 is similar to the reference product Keytruda for patients with completely resected Stage IIB/IIC or Stage III melanoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

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 Locations

  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina
        • Formycon Investigative Site
  • Bulgaria
      • Sofia, Bulgaria
        • Formycon Investigative Site
  • Estonia
      • Tartu, Estonia
        • Formycon Investigative Site
  • Georgia
      • Batumi, Georgia
        • Formycon Investigative Site
      • Kutaisi, Georgia
        • Formycon Investigative Site
      • Tbilisi, Georgia
        • Formycon Investigative Site
  • Lithuania
      • Kaunas, Lithuania
        • Formycon Investigative Site
  • Moldova
      • Chisinau, Moldova
        • Formycon Investigative Site
  • North Macedonia
      • Skopje, North Macedonia
        • Formycon Investigative Site
  • Poland
      • Krakow, Poland
        • Formycon Investigative Site
      • Lodz, Poland
        • Formycon Investigative Site
  • Romania
      • Bucharest, Romania
        • Formycon Investigative Site
      • Cluj-Napoca, Romania
        • Formycon Investigative Site
  • Serbia
      • Belgrade, Serbia
        • Formycon Investigative Site
      • Kragujevac, Serbia
        • Formycon Investigative Site
      • Niš, Serbia
        • Formycon Investigative Site
  • Ukraine
      • Kyiv, Ukraine
        • Formycon Investigative Site

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:

  • 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.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FYB206
Biological: FYB206
FYB206 (Keytruda biosimilar candidate - test product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle
Active Comparator: Keytruda
Biological: Keytruda
Keytruda (reference product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCtau,sd at Cycle 1
Time Frame: 21 days
Area under the concentration curve for one dosing interval (tau=21 days) after a single (initial) dose (AUCtau,sd) of FYB206 and Keytruda (Cycle 1)
21 days
AUCtau,sd at Cycle 6
Time Frame: 126 days
Area under the concentration curve for one dosing interval (tau=21 days) at steady state (AUCtau,ss) of FYB206 and Keytruda (Cycle 6)
126 days

Collaborators and Investigators

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

Sponsor

Formycon AG

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 (Actual)

July 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FYB206-C1-01
  • 2023-509765-20-00 (Ctis)

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

Yes

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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