NCT04447092

Pembrolizumab Plus Chemotherapy in 1st Line Treatment of Pancreatic Cancer

Biomarker-oriented Study of Pembrolizumab in Combination With Chemotherapy in Chemotherapy -naïve Advanced Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Pancreatic Cancer
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine 1000 mg/m2 iv D1, 8, 15 (every 4 weeks)
DRUG	Nab-paclitaxel	Nab-paclitaxel 125 mg/m2 iv D1, 8, 15 (every 4 weeks)
DRUG	Pembrolizumab	Pembrolizumab ( 200 ) mg iv D1 (every 3 weeks)
DRUG	Oxaliplatin	Oxaliplatin 65 mg/m2 iv over 2 hours D1 (every 2 weeks)
DRUG	Leucovorin	Leucovorin 400 mg/m2 iv D1 (every 2 weeks)
DRUG	Irinotecan	Irinotecan 140 mg/m2 iv over 1.5 hours D1 (every 2 weeks)
DRUG	5FU	5-FU 2400 mg/m2 iv over 46 hours D1 (every 2 weeks)

Timeline

• Start date: 2020-07-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2020-06-25
• Last updated: 2024-04-19

Locations

1 site across 1 country: South Korea