Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cance… (NCT04161755) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery
United States29 participantsStarted 2019-12-13
Plain-language summary
The purpose of this study is to evaluate the safety or treating pancreatic cancer with surgery to remove cancerour tissue, followed by atezolizumab, followed by a personalized cancer vaccine (PCV), and then with chemotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects must be \>/= 18 years of age at time of informed consent
* Able to comply with the study protocol, in the investigator's judgment
* Subjective with radiographically resectable primary pancreatic tumors with radiographic features consistent with adenocarcinoma will be evaluated for surgical resection
* Tumors must be radiographically resectable, defined as:
* A clear fat plane around the celiac and superior mesenteric arteries
* patent superior mesenteric and portal veins without primary tumor involvement
* No encasement of the superior mesenteric vein or portal veins
* No encasement of the superior mesenteric or hepatic arteries
* No metastatic disease
* No extra-regional nodal disease
* Subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation. Subjects with neuroendocrine (and mixed type) tumors are excluded
* Pancreatic cancer surgical staging: T 1-3, N0-2, M0
° Per AJCC 8th edition staging
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status (Section 20.0 APPENDICES, Appendix1)
* Subjects must not have had prior chemotherapy, radiation therapy, or immunotherapy for PDAC
* Subjects must be able to read, understand, and sign informed consent
* Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to study init…