Pembrolizumab Plus Chemotherapy in 1st Line Treatment of Pancreatic Cancer

Status Active, not recruiting

Clinical Trial Summary

This is an open-label, phase 2 study of Pembrolizumab in combination with chemotherapy in chemotherapy-naïve advanced pancreatic cancer

Clinical Trial Description

- In unresectable advanced pancreatic cancer, palliative chemotherapy (mainly Gemcitabine/nab-Paclitaxel or FOLFIRINOX) is the mainstay of treatment. Regardless of the choice of first-line therapy, more than half of the patients with advanced/metastatic disease will progress within six months and will not survive more than one year. - Immune cells (IC) are a significant part of the pancreatic tumor-associated stroma and play a fundamental part in maintaining a non-immunogenic and immuno-suppressive environment. - IO (Immuno-Oncology drug) monotherapy is not effective in advanced pancreatic cancer; therefore, we need more active combination regimens including IO/IO or IO/chemotherapy, etc. Furthermore, we need biomarker study to uncover which population is an optimal target for this IO-based treatment strategy. - Based on these rationale, we plan to conduct an open-label, phase 2 study to explore biomarkers and evaluate the safety and efficacy of the pembrolizumab/chemotherapy combination in an advanced pancreatic cancer primary environment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04447092
Study type	Interventional
Source	Seoul National University Hospital
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	July 1, 2020
Completion date	December 31, 2025

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