Clinical Trial TitleOpen-label, randomized Phase II trial with BNT111 and cemiplimab in combination or as single agents in patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV melanoma
National Clinical Trial Number:NCT04526899
Clinical Trial Protocol Description:
This is an open-label, randomized, multi-site, phase II, interventional trial designed to evaluate the efficacy, tolerability and safety of BNT111 + cemiplimab in patients with advanced melanoma (skin cancer).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Patients should have received pembrolizumab or nivolumab (with/without ipilimumab).
- Patients should have received at least 1 but no more than 5 lines of prior therapy for advanced disease.
- Patients must be able to tolerate additional anti-PD1 therapy (i.e., did not permanently discontinue anti-PD1 therapy due to toxicity).
- Patients must have known BRAF mutation status.
You will be excluded from the study if any of the following criteria apply to you:
- Patients must not be pregnant or breastfeeding.
- Patients must not have history of uveal, acral, or mucosal melanoma.
- Patients must have no ongoing or recent evidence (within the last 5 years) of significant autoimmune disease that required treatment with systemic immunosuppressive treatments which may suggest risk for immune-related adverse events (irAEs).
- Patients must have no known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T cell-negative severe combined immunodeficiency [SCID]) or combined T and B cell immunodeficiencies (e.g., T and -B negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency).
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.