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

Launched by FORMYCON AG · Aug 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called FYB206, which is designed to be similar to an existing cancer therapy known as Keytruda. Both treatments aim to help the immune system recognize and attack melanoma, a type of skin cancer. The trial will compare how FYB206 works in the body to Keytruda in patients who have had their melanoma completely removed through surgery. Researchers hope to confirm that FYB206 has similar effects and safety to Keytruda.

To participate in this trial, you need to be an adult aged 18 or older who has been diagnosed with Stage IIB, IIC, or III melanoma and has had surgery to remove the cancer within the past 12 weeks. Participants should not have received certain previous cancer treatments or have specific other health conditions. If you join the trial, you will receive either FYB206 or Keytruda and will be monitored for how your body processes the treatment. This study is currently recruiting participants, and it aims to improve options for melanoma patients in the future.

Gender

ALL

Eligibility 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.