Multicenter, randomized, parallel group, phase 2 study to establish the efficacy and safety of combinations of CBP501, cisplatin, and nivolumab for greater than or equal to 3rd line treatment of patients with exocrine pancreatic cancer and WBC <10,000/mm3 at screening
- 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. - Patient must not have received more than two prior lines incorporating anti-PD-1, anti-PD-L1, or anti-CTLA-4 immune checkpoint blockade. - Radiation therapy to >30% of bone marrow prior to study entry is NOT permitted. - Evidence of peripheral neuropathy grade ≥ 2 NOT permitted. - Active CNS mets NOT permitted.
University of Colorado Hospital
Wells Messersmith, MD
Protocol Number: 21-5119
More information available at ClinicalTrials.gov: NCT04953962
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