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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06551064
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Formycon AG
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Bulgaria, Estonia, Macedonia, The Former Yugoslav Republic of, Moldova, Republic of, Romania, Ukraine
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma, Stage II, Melanoma Stage III

Arms & Interventions

Arms

Experimental: FYB206

Active Comparator: Keytruda

Interventions

Biological: - FYB206

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

Biological: - Keytruda

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

Contact a Trial Team

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