A Phase Ib/II Open Label Umbrella Study Evaluating Immunotherapy Based Combinations with Metastatic Pancreas Adenocarcinoma.
This study is a open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC).
Are you Eligible? (Inclusion Criteria)
- ECOG score of 0-1
- Definitive diagnosis of metastatic PDAC is made by evaluating the histopathologic data within the context of clinical and radiographic data
- Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status via central testing
- Lymphocyte count ≥ 0.5×109 /L (500/µL)
- Disease progression during or within 6 months after treatment with one line of 5-FU− or gemcitabine-based chemotherapy in the metastatic setting Prior chemotherapy administered as a radiation sensitizer will not be considered first-line chemotherapy (COHORT 2)
- Known dihydropyrimidine dehydrogenase deficiency
- No prior systemic treatment for PDAC (COHORT 1)
- No prior treatment systemic immunostimulatory agents.
- Uncontrolled hypercalcemia.
- Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty liver disease, and inherited liver disease
- History of malignancy other than pancreatic carcinoma within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%)
Columbia University Medical Center
Herbert Irving Pavilion
161 Fort Washington Avenue, 8th Floor
New York, NY 10032