Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer

Inclusion criteria

• . Signed informed consent obtained prior to initiation of any study-specific procedures and treatment;
• . Patients with pathologically confirmed stage IV exocrine pancreatic cancer who have received at least two lines of systemic therapy for metastatic disease. Up to 10 of prior lines of systemic therapy (including prior cisplatin), chemoradiotherapy, radiotherapy or investigational agents the patient has received are allowed in order to be eligible, as long as all eligibility criteria are met, with the exception that a patient must not have received more than two prior lines incorporating anti-PD-1, anti-PD-L1, or anti-CTLA-4 immune checkpoint blockade.
• . Male or female patients aged ≥ 18 years at time of informed consent;
• . ECOG Performance Status (PS) 0-1;
• . Life expectancy \> 3 months;
• . Previous anticancer treatment must be discontinued at least 3 weeks prior to the initiation of study treatment (with the exception of 6 weeks for mitomycin C; 6 weeks for anti-androgen therapy if discontinued prior to treatment initiation, and 8 weeks for bicalutamide);
• . Adequate bone marrow reserve, cardiac, liver, renal and metabolic function:
• . Female patients of child-bearing potential must have a negative serum pregnancy test and use at least one form of contraception as approved by the investigator for 4 weeks prior to initiating study treatment and for 14 months after the last dose of study drug . For the purposes of this study, child-bearing potential is defined as "all female patients unless they are post-menopausal for at least 3 years or surgically sterile;