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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
EU CTIS ID: 2022-502404-73-00
What this study is testing
To evaluate the efficacy of autogene cevumeran + atezolizumab + mFOLFIRINOX compared with mFOLFIRINOX based on disease-free survival (DFS) after randomization
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 initiation of study treatment
You likely can't join if
- 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, 9 months after the last dose of chemotherapy, or 5 months after the final dose of atezolizumab, (15 months after the final dose of oxaliplatin in Korea) 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Korea, Republic of
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Korea, Republic of; United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.