Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chemotherapy Effect
  • Pancreatic Cancer
Type
Interventional
Phase
Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04447092
Collaborators
Not Provided
Investigators
Study Director: Do-Youn Oh, M.D., PhD. Seoul National University Hospital