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

NCT06551064 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: FYB206-C1-012023-509765-20-00
• Study Type: interventional
• Target: 96
• Locations: 11 countries
• Sites: 17

Brief Summary

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.

Conditions

Melanoma, Stage II; Melanoma Stage III

Keywords

pembrolizumab; biosimilar; melanoma

Outcome Measures

Primary Outcomes (2)

• AUCtau,sd at Cycle 1

  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

  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

Study Arms (2)

FYB206

EXPERIMENTAL

Biological: FYB206

Keytruda

ACTIVE COMPARATOR

Biological: Keytruda

Interventions

FYB206 BIOLOGICAL

FYB206 (Keytruda biosimilar candidate - test product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle

FYB206

Keytruda BIOLOGICAL

Keytruda (reference product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle

Keytruda

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Formycon AG: lead

Study Sites (17)

Formycon Investigative Site

Sarajevo, Bosnia and Herzegovina

Location

Formycon Investigative Site

Sofia, Bulgaria

Location

Formycon Investigative Site

Tartu, Estonia

Location

Formycon Investigative Site

Batumi, Georgia

Location

Formycon Investigative Site

Kutaisi, Georgia

Location

Formycon Investigative Site

Tbilisi, Georgia

Location

Formycon Investigative Site

Kaunas, Lithuania

Location

Formycon Investigative Site

Chisinau, Moldova

Location

Formycon Investigative Site

Skopje, North Macedonia

Location

Formycon Investigative Site

Krakow, Poland

Location

Formycon Investigative Site

Lodz, Poland

Location

Formycon Investigative Site

Bucharest, Romania

Location

Formycon Investigative Site

Cluj-Napoca, Romania

Location

Formycon Investigative Site

Belgrade, Serbia

Location

Formycon Investigative Site

Kragujevac, Serbia

Location

Formycon Investigative Site

Niš, Serbia

Location

Formycon Investigative Site

Kyiv, Ukraine

Location

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

Study Design

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

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1); SE (3); ES (1); PL (2); MO (1); BO (1); UA (1); RO (2); GE (3); NO (1); BU (1)