IMCODE003 GO44479 A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC

Section NCT
Category Gastrointestinal tumors
Subcategory Pancreatic cancer
Trial Type other systemic therapies
Description for experts The purpose of this study is to evaluate the efficacy and safety of adjuvant autogenecevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan,and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancertreatment for PDAC and have no evidence of disease after surgery. 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
Description for laymen 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
JSON Data { "short_title": "IMCODE003 GO44479 A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC", "data_mode": "900", "data_mode_number": "000002480", "official_title": "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", "accrual_state": "planned", "therapeutic_value": "therapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "adjuvant", "therapielinie_value": "not_applicable", "ctgov_number": "NCT05968326", "eudract_number": null, "general_contact_email": "oncostudy@ukdd.de", "general_contact_phone": "+49 351-4587666", "hauptpruefer_dd_name": null, "description_laie_de": "PHASE II, OPEN-LABEL, MULTICENTER, \r\nRANDOMISIERTE STUDIE ZUR WIRKSAMKEIT UND \r\nSICHERHEIT VON ADJUVANTE AUTOGENE CEVUMERAN \r\nPLUS ATEZOLIZUMAB UND mFOLFIRINOX VERSUS \r\nmFOLFIRINOX ALLEIN BEI PATIENTEN MIT RESPEKTIERTEM \r\nPANZREATISCH-DUKTALEM ADENOKARZINOM", "description_laie_en": "A PHASE II, OPEN-LABEL, MULTICENTER, \r\nRANDOMIZED STUDY OF THE EFFICACY AND \r\nSAFETY OF ADJUVANT AUTOGENE CEVUMERAN \r\nPLUS ATEZOLIZUMAB AND mFOLFIRINOX VERSUS \r\nmFOLFIRINOX ALONE IN PATIENTS WITH RESECTED \r\nPANCREATIC DUCTAL ADENOCARCINOMA", "description_expert_de": "PHASE II, OPEN-LABEL, MULTICENTER, \r\nRANDOMISIERTE STUDIE ZUR WIRKSAMKEIT UND \r\nSICHERHEIT VON ADJUVANTE AUTOGENE CEVUMERAN \r\nPLUS ATEZOLIZUMAB UND mFOLFIRINOX VERSUS \r\nmFOLFIRINOX ALLEIN BEI PATIENTEN MIT RESPEKTIERTEM \r\nPANZREATISCH-DUKTALEM ADENOKARZINOM", "description_expert_en": "The purpose of this study is to evaluate the efficacy and safety of adjuvant autogenecevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan,and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancertreatment for PDAC and have no evidence of disease after surgery.\r\n A PHASE II, OPEN-LABEL, MULTICENTER, \r\nRANDOMIZED STUDY OF THE EFFICACY AND \r\nSAFETY OF ADJUVANT AUTOGENE CEVUMERAN \r\nPLUS ATEZOLIZUMAB AND mFOLFIRINOX VERSUS \r\nmFOLFIRINOX ALONE IN PATIENTS WITH RESECTED \r\nPANCREATIC DUCTAL ADENOCARCINOMA", "rechtsgrundlage_value": "AMG", "phase_amg_value": "II", "main_cat_id": 2, "sub_cat_id": 4 }
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Short name 900-000002480