Primary Efficacy Objective~Corresponding Endpoint To obtain a preliminary estimate of the ORR* of the combination of pembrolizumab and lenvatinib in patients with advanced pancreatic ductal adenocarcinoma ORR, defined by the proportion of participants who have a CR or PR as determined by RECIST version~Secondary Objective~Corresponding Endpoints~• Determine progression free survival (PFS) according to RECIST version 1.1 and iRECIST.~PFS defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first~To estimate DOR according to RECIST v1.1 and iRECIST.~DOR defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first~To estimate DCR using RECIST 1.1 and with confirmatory assessment as required by iRECIST at any time during the trial.~DCR defined as the proportion of subjects who have a CR, PR, or SD~To evaluate the efficacy, toxicity and survival following treatment with pembrolizumab and lenvatinib • OS defined as the time from the date of enrollment to the date of death due to any cause.~Occurrence and severity of AEs, with severity determined according to NCI CTCAE,~Exploratory Objective~Corresponding Endpoints To identify molecular (genomic, metabolic, and/or proteomic) biomarkers that may be indicative of clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of pembrolizumab and lenvatinib Molecular (genomic, metabolic and/or proteomic) determinants of response or resistance to treatments, using blood and/or tumor tissue~Change in T-cell composition of tumor as identified by multiplex immunofluorescent assay of serial biopsies obtained from patients. Tumor infiltrate will be assessed for any change in response to this therapeutic approach.~Additional measurements will include changes in immune composition of tumor stroma, T-cell receptor composition in infiltrating T cells, and serum cytokines. Tumor infiltrate and circulating cytokines will be assessed for change in response to these therapies.
This is a clinical research study to learn if pembrolizumab in combination with lenvatinib can help to control pancreatic ductal adenocarcinoma.