drugset / Trial / NCT04543071

Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma

NCT04543071

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing the size of the tumor(s), if it will prolong life in patients, and if it's safe. The treatment consists of standard chemotherapy (gemcitabine and nab-paclitaxel) which is FDA approved and is standard treatment for patients with pancreatic adenocarcinoma. Participants will receive immunotherapy (cemiplimab) which activates the body's immune system to attack cancer cells. Cemiplimab is FDA approved for treatment of skin cancer but not for pancreas cancer. Participants will also receive Motixafortide, a new medication which has shown in the laboratory to help immunotherapy work better. Motixafortide has been tested together with immunotherapy (Pembrolizumab), and chemotherapy (5-Fluorouracil and liposomal Irinotecan) and was deemed safe to test additional patients. Motixafortide has not been tested with the specific immunotherapy (Cemiplimab) and chemotherapy (gemcitabine and nab-paclitaxel) which participants will receive and is being tested in this clinical trial.

Timeline

Start
2020-11-09
Primary completion
2028-06
Completion
2028-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cemiplimab Monoclonal antibody 350 mg Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Motixafortide Peptide 1.25 mg/kg Subcutaneous
Subject Paclitaxel Small molecule 125 mg/m2 Intravenous