A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX versus mFOLFIRINOX Alone in Patients with Resected Pancreatic Ductal Adenocarcinoma - GO44479

Genentech Inc.0 个研究点目标入组 566 人开始时间: 2023年8月29日最近更新: 2024年8月21日

适应症

试验速览

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•??Preoperative diagnosis of resectable PDAC tumor, ??Histologically confirmed diagnosis of PDAC, ??Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Staging Manual, 8th edition, ??Macroscopically complete (R0 or R1) resection of PDAC, ??Unequivocal absence of disease after surgery as assessed by the investigator and based on review of all available data including mandatory imaging [computed tomography (CT) or magnetic resonance imaging (MRI) scans], biochemical data, and clinical findings within 28 days prior to randomization, ??Carbohydrate antigen 19-9 (CA19-9) level measured within 14 days prior to randomization

•??Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer, including cytotoxic chemotherapy, immunotherapy, investigational therapy, or radiation therapy, ??Absence of spleen (due to splenectomy, splenic injury/infarction, or functional asplenia), ??Active or history of autoimmune disease or immune deficiency, ??Unresolved >=Grade 3 postoperative complication(s) per the Clavien-Dindo Classification of Surgical Complications, ??Pregnancy or breastfeeding , or intention of becoming pregnant during study treatment or within 28 days after the final dose of autogene cevumeran, 6 months after the last dose of chemotherapy, or 5 months after the final dose of atezolizumab, whichever period ends later, ??Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

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