A Phase 1b Study to Determine the Safety and Tolerability and Confirm the Dose of Canakinumab and Spartalizumab in Combination With Nab-paclitaxel and Gemcitabine for Patients with Metastatic Pancreatic Cancer

Brief description of study

The purpose of this study is to find out the tolerable dose and how safe the administration of the combination of canakinumab and spartalizumab with nab-paclitaxel and gemcitabine (4-drug combination).The combination of nab-paclitaxel and gemcitabine has been approved by the Food and Drug Administration (FDA) and is standard therapy for the treatment of metastatic pancreatic cancer. Canakinumab works by decreasing your body’s inflammatory response to disease. Spartalizumab works by boosting the body’s own immune system to fight cancer cells. Neither canakinumab nor spartalizumab are approved by the FDA for the treatment of metastatic pancreatic cancer, but the FDA has given its permission to test these agents in the current trial.


Clinical Study Identifier: s20-01013
ClinicalTrials.gov Identifier: NCT04581343
Principal Investigator: Paul E. Oberstein.


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