This is an open-label, phase 2 study of Pembrolizumab in combination with chemotherapy in chemotherapy-naïve advanced pancreatic cancer
* 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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Gemcitabine 1000 mg/m2 iv D1, 8, 15 (every 4 weeks)
Nab-paclitaxel 125 mg/m2 iv D1, 8, 15 (every 4 weeks)
Pembrolizumab ( 200 ) mg iv D1 (every 3 weeks)
Seoul National University Hospital
Seoul, South Korea
Objective Response Rate
The percentage of patients whose optimal response achieves CR or PR between the initial response assessment and the time between treatment termination or intermediate dropout due to any cause
Time frame: 8 weeks
Progression-free survival
Time from enroll until disease progression or death
Time frame: 8 weeks
Duration of response
Time from enroll untill disease progression or death in patients whose optimal response achieves CR or PR
Time frame: 8 weeks
Disease control rate
The percentage of patients who have achieved complete response, partial response and stable disease
Time frame: 8 weeks
Overall survival
Time from enroll until death from any cause
Time frame: 8 weeks
Immune-related response
RECIST 1.1, ir response
Time frame: 8 weeks
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Oxaliplatin 65 mg/m2 iv over 2 hours D1 (every 2 weeks)
Leucovorin 400 mg/m2 iv D1 (every 2 weeks)
Irinotecan 140 mg/m2 iv over 1.5 hours D1 (every 2 weeks)
5-FU 2400 mg/m2 iv over 46 hours D1 (every 2 weeks)