Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Formycon AG
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients
