A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer

Official Title

A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination With Nivolumab (BMS-936558) With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer

Summary:

The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.

Trial Description

Primary Outcome:

• Progression free survival (PFS) by Blinded Independent Central Review (BICR)

• Progression Free Survival (PFS) by Investigator Assessment
• Progression Free Survival Rate (PFSR)
• Objective response rate (ORR)
• Duration of response (DOR)
• Overall Survival (OS)
• Overall survival rate (OSR)
• Incidence of Adverse Events (AE)
• Incidence of Serious Adverse Events (SAE)
• Incidence of Adverse Events (AE) leading to discontinuation
• Incidence of death
• Number of clinically significant changes in lab assessment: Blood
• Number of clinically significant changes in lab assessment: Blood Serum
• Number of clinically significant changes in lab assessment: Urine

View this trial on ClinicalTrials.gov