Comparing FYB206 to Keytruda in melanoma patients after surgery
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
This study tests if FYB206, a new treatment similar to Keytruda, works as well for adults with melanoma after surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Formycon AG Industry-sponsored |
| Drugs / interventions | ipilimumab, radiation, prednisone, Pembrolizumab |
| Locations | 9 sites (Sofia and 8 other locations) |
| Trial ID | NCT06551064 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the pharmacokinetic similarity of FYB206, a proposed biosimilar to Keytruda, in patients with resected Stage II or III melanoma. The study involves adult patients who have undergone complete surgical removal of their melanoma and assesses how FYB206 performs compared to the established treatment, Keytruda. Participants will be monitored for their response to the treatment and any potential side effects, contributing to the understanding of FYB206's effectiveness and safety profile.
Who should consider this trial
Good fit: Ideal candidates are Caucasian adults aged 18 and older with Stage IIB, IIC, or III melanoma who have had their cancer completely resected within the last 12 weeks.
Not a fit: Patients with a history of radiation therapy for melanoma prior to trial entry may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible treatment option for melanoma patients, potentially improving outcomes and reducing costs.
How similar studies have performed: Other studies have shown success with biosimilars in oncology, indicating that this approach has potential but remains a developing area.
Eligibility criteria
Show full 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.
Where this trial is running
Sofia and 8 other locations
- Formycon Investigative Site — Sofia, Bulgaria (Recruiting)
- Formycon Investigative Site — Tartu, Estonia (Recruiting)
- Formycon Investigative Site — Kaunas, Lithuania (Recruiting)
- Formycon Investigative Site — Skopje, Macedonia, The Former Yugoslav Republic of (Recruiting)
- Formycon Investigative Site — Chisinau, Moldova, Republic of (Recruiting)
- Formycon Investigative Site — Bucharest, Romania (Recruiting)
- Formycon Investigative Site — Cluj Napoca, Romania (Recruiting)
- Formycon Investigative Site — Niš, Serbia (Recruiting)
- Formycon Investigative Site — Kyiv, Ukraine (Recruiting)
Study contacts
- Study coordinator: Public Register Contact
- Email: clinicaltrials@formycon.com
- Phone: +49 89 864667 100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.