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

Bereich NCT
Kategorie Gastrointestinale Tumore
Unterkategorie Pankreaskarzinom
Studientyp weitere Systemtherapie Studien
Beschreibung für Experten PHASE II, OPEN-LABEL, MULTICENTER, RANDOMISIERTE STUDIE ZUR WIRKSAMKEIT UND SICHERHEIT VON ADJUVANTE AUTOGENE CEVUMERAN PLUS ATEZOLIZUMAB UND mFOLFIRINOX VERSUS mFOLFIRINOX ALLEIN BEI PATIENTEN MIT RESPEKTIERTEM PANZREATISCH-DUKTALEM ADENOKARZINOM
Beschreibung PHASE II, OPEN-LABEL, MULTICENTER, RANDOMISIERTE STUDIE ZUR WIRKSAMKEIT UND SICHERHEIT VON ADJUVANTE AUTOGENE CEVUMERAN PLUS ATEZOLIZUMAB UND mFOLFIRINOX VERSUS mFOLFIRINOX ALLEIN BEI PATIENTEN MIT RESPEKTIERTEM PANZREATISCH-DUKTALEM ADENOKARZINOM
JSON Daten { "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 }
Einstellungen
Kurzname 900-000002480