Autogene cevumeran
DrugAutogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.
NCT Number: NCT05968326
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran 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-cancer treatment for PDAC and have no evidence of disease after surgery.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Antwerp University Hospital, Edegem, VAN, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.
Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.
Other names: Tecentriq
mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.
Time frame: From randomization to first recurrence of PDAC or first occurrence of new cancer, as determined by the investigator, or death from any cause (whichever occurs first), up to approximately 6 years
Time frame: Months 12, 24, 36
Time frame: From randomization to death from any cause (up to approximately 6 years)
Time frame: Years 3 and 5
Time frame: Up to approximately 6 years
Contact information is provided by the study sponsor or research team.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Reference Study ID Number: GO44479 https://forpatients.roche.com/ No attachments to email below.
CONTACT
888-662-6728 (U.S. Only)
Genentech, Inc.
Industry
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
Acronym: IMCODE003
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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