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A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone in Subjects with Resected Solid Tumors and in Combination with Pembrolizumab in Subjects with Unresectable Solid Tumors
The purpose of this study is to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone in participants with resected solid tumors and in combination with pembrolizumab in participants with unresectable solid tumors.
Primary Objectives: For Part A To determine the safety and tolerability of mRNA-4157 monotherapy in subjects with resected solid tumors. For Parts B, C and D To determine the safety, tolerability, and RP2D of mRNA-4157 administered in combination with pembrolizumab. Secondary Objectives: For Part A apheresis expansion cohort To assess the immunogenicity of mRNA-4157 from apheresis samples in subjects with resected solid tumors. For Part B biopsy expansion cohort To assess modulation of relevant biomarkers in tumors by mRNA- 4157 in combination with pembrolizumab. For Part C HNSCC cohort: To characterize preliminary antitumor activity of mRNA4157 in combination with pembrolizumab. For Part D To assess the immunogenicity of mRNA-4157 and pembrolizumab from apheresis samples in subjects with resected cutaneous melanoma.
Chemotherapy (NOS); Immunotherapy
Pembrolizumab (Keytruda); mRNA-4157 ()
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