A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX versus mFOLFIRINOX Alone in Patients with Resected Pancreatic Ductal Adenocarcinoma
- Conditions
- Pancreatic ductal adenocarcinomaMedDRA version: 21.1Level: LLTClassification code: 10051971Term: Pancreatic adenocarcinoma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-502404-73-00
- Lead Sponsor
- Genentech Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 566
??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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ??To evaluate the efficacy of autogene cevumeran + atezolizumab + mFOLFIRINOX compared with mFOLFIRINOX based on disease-free survival (DFS) after randomization;Secondary Objective: ??To evaluate the efficacy of autogene cevumeran + atezolizumab + mFOLFIRINOX compared with mFOLFIRINOX based on DFS rates at 12, 24, and 36 months, overall survival (OS) after randomization, and OS rates at 3 and 5 years, ??To evaluate the safety of autogene cevumeran + atezolizumab + mFOLFIRINOX compared with mFOLFIRINOX;Primary end point(s): 1. DFS after randomization
- Secondary Outcome Measures
Name Time Method Secondary end point(s):1. DFS rates at 12, 24, and 36 months;Secondary end point(s):2. OS after randomization;Secondary end point(s):3. OS rates at 3 and 5 years;Secondary end point(s):4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) grading scale;Secondary end point(s):5. Change from baseline in targeted vital signs;Secondary end point(s):6. Change from baseline in targeted clinical laboratory test results