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Phase IB Study of Avelumab with Radiotherapy in Patients with Leptomeningeal Disease
Objectives: Primary Objectives: To establish the safety of combination of Avelumab and WBRT in patients with LMDz and perform exploratory analysis of the patient survival rate. Secondary Objectives: To gather preliminary data regarding clinical outcomes of the study therapy Endpoints: Primary Endpoints: 1) Safety and dose limiting toxicities. 2) The proportion of patients surviving at least 15 weeks after the first dose of Avelumab. Secondary Endpoints: 1) The number and activation status of T cells and the CSF cytokine activation profile in the CSF (relative to serum and relative to collection time), measured before and after Avelumab administration; 2) LMDz/central nervous system response rate and systemic (i.e., non-central nervous system) response rates; 3) the association between serum/CSF levels of Avelumab/activated T-cell responses and clinical toxicities and responses; 4) overall survival and progression-free survival; 5) the association between enumerated CSF circulating tumor cells, conventional CSF cytology, and response rates; 6) evolution of clinical status associated with the cardinal CSF biomarkers; and 7) levels of Avelumab in the serum and CSF.