Study on the Effectiveness and Safety of Autogene Cevumeran, Atezolizumab, and mFOLFIRINOX in Patients with Resected Pancreatic Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of pancreatic ductal adenocarcinoma, a type of cancer that starts in the ducts of the pancreas. The study will compare the effectiveness and safety of a combination treatment involving Autogene Cevumeran and Atezolizumab with a chemotherapy regimen called mFOLFIRINOX, against mFOLFIRINOX alone. Autogene Cevumeran is a type of gene therapy that uses mRNA, a molecule that carries genetic information, to help the body recognize and fight cancer cells. Atezolizumab is an immunotherapy drug that helps the immune system attack cancer cells. mFOLFIRINOX is a combination of chemotherapy drugs used to treat pancreatic cancer.

The purpose of this study is to evaluate how well the combination of Autogene Cevumeran, Atezolizumab, and mFOLFIRINOX works compared to mFOLFIRINOX alone, by looking at how long patients remain free of cancer after treatment. Participants in the study will be randomly assigned to receive either the combination treatment or mFOLFIRINOX alone. The study will last for up to 12 months, during which participants will receive their assigned treatment and be monitored for any side effects and the effectiveness of the treatment.

Throughout the study, participants will undergo regular check-ups, including imaging tests like MRI or CT scans, to assess the status of their cancer. The study aims to provide valuable information on whether adding Autogene Cevumeran and Atezolizumab to the standard mFOLFIRINOX treatment can improve outcomes for patients with pancreatic ductal adenocarcinoma. This research could potentially lead to new treatment options for this type of cancer.

1 randomization

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of autogene cevumeran, atezolizumab, and mFOLFIRINOX, while the other group will receive mFOLFIRINOX alone. This process is called randomization and ensures that each participant has an equal chance of being placed in either group.

2 treatment administration

If you are in the group receiving the combination treatment, you will receive autogene cevumeran and atezolizumab along with mFOLFIRINOX. mFOLFIRINOX includes medications such as calcium folinate, fluorouracil, oxaliplatin, and irinotecan hydrochloride. These medications are administered through an intravenous infusion, which means they are given directly into your bloodstream through a vein.

The specific dosages and frequency of administration will be determined by the study protocol and your healthcare team. The duration of the treatment phase will be specified by the study and communicated to you by your healthcare provider.

3 monitoring and follow-up

Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging scans such as CT or MRI to assess your condition and the effectiveness of the treatment.

You will also be asked to report any side effects or changes in your health to the study team. This information is crucial for evaluating the safety and efficacy of the treatment.

4 end of study participation

At the end of the study, you will have a final evaluation to assess your overall health and the outcomes of the treatment. This may include additional tests and consultations with your healthcare team.

You will be informed about the results of the study and any potential next steps in your treatment plan.

Who Can Join the Study?

Diagnosis of a resectable PDAC tumor before surgery. PDAC stands for Pancreatic Ductal Adenocarcinoma, a type of pancreatic cancer.
Confirmation of PDAC through a test called a histological diagnosis, which examines tissue under a microscope.
The cancer must be staged as T1-T3, N0-N2, and M0 according to the American Joint Committee on Cancer (AJCC) Staging Manual, 8th edition. This means the tumor is of a certain size and has not spread to distant parts of the body.
The tumor must have been completely removed through surgery, which is referred to as a macroscopically complete (R0 or R1) resection.
No signs of the disease should be present after surgery, as determined by the doctor. This includes reviewing all available data such as imaging tests like CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) scans, blood tests, and clinical findings within 28 days before starting the study.
A blood test measuring Carbohydrate Antigen 19-9 (CA19-9) levels must be done within 14 days before starting the study treatment. CA19-9 is a substance that can be found in higher levels in people with certain types of cancer.
Both male and female participants are eligible.
Participants from vulnerable populations are also eligible.

Who Cannot Join the Study?

Patients with any other type of cancer besides pancreatic ductal adenocarcinoma cannot participate.
Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma or in situ cervical cancer, are excluded.
Patients with serious heart problems, such as heart failure or a recent heart attack, are not eligible.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with active infections, including HIV, hepatitis B, or hepatitis C, are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with known allergies to the study drugs or similar drugs are not eligible.
Patients who have received another investigational drug within the last 4 weeks are excluded.
Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body, cannot participate.
Patients with a history of organ transplant are not eligible.
Patients with any condition that the study doctors believe would make it unsafe for them to participate are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Institut Gustave Roussy	Villejuif	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Universitario Central De Asturias	Oviedo	Spain
Karolinska University Hospital	Solna	Sweden
Hospital Universitario 12 De Octubre	Madrid	Spain
Muenchen Klinik gGmbH	Munich	Germany
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Universitair Ziekenhuis Gent	Gent	Belgium
Deutsches Herzzentrum Berlin	Berlin	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Az Maria Middelares Gent	Gent	Belgium
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Hjvmxvnl Usmjlnyaiaxad Rzdjicxb Ds Modcao	Malaga	Spain
Ccpwsgp Uzfbuitfoey Dz Nsdpzou	Madrid	Spain
Uijlqgzorl Hkhnwekr Cpjpphe	Cologne	Germany
Asuywmhii Uzm	Amsterdam	The Netherlands
Sneicyqgn Rughqzg Uksnyvtswg Mthkyvz Cyyftr	Nijmegen	The Netherlands
Ezqthyl Uqstvtqefhxa Mqsxtih Cfjgblm Rvxjsayit (rmxakhq Msg	Rotterdam	The Netherlands
Sazukxbxbcw Ueuoyojkbh Hnckcvhkmcnbzxd Gvwbtydjwhaaeqbew	Gothenburg	Sweden
Ksokmyaw dxu Uzcficklnzry Mtytbbxl Ajt	Munich	Germany
Uppulpejsdlodopkpybaz Wjuhnnieb Acl	Wuerzburg	Germany
Ctoxgs Lyyc Bxpgsz	Lyon	France
Ucxyvktnzo Oq Aobduax	Edegem	Belgium
Unemfvfumj Mllwqss Cqafvy Hqkwltemqruetfjcb	Hamburg	Germany
Uwjaiqnnppchlmddxiknf Eehgj Ajy	Essen	Germany
Hhuzsesa Uelcpmndxnyjt Hrxcsrfc Tuhke y Pqfdcy Ilgaxzfg Cqnohr dftmjiyrzrldoxlhx (gucn	Badalona	Spain
Hdtamcvu Vfjm diwovves	Barcelona	Spain
Ihumjzir Pzticnijkmduvfp Cgcoot Cimpod	Marseille	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	18.03.2024
France	Recruiting	18.03.2024
Germany	Recruiting	18.03.2024
Spain	Recruiting	18.03.2024
Sweden	Recruiting	18.03.2024
The Netherlands	Recruiting	18.03.2024

Trial locations

Autogene Cevumeran is a type of personalized cancer vaccine. It is designed to help your immune system recognize and attack cancer cells more effectively. This vaccine is made specifically for each patient, using information from their own tumor to create a treatment that targets their cancer.

Atezolizumab is an immunotherapy drug that helps your immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells. By doing this, atezolizumab helps your body’s natural defenses to better recognize and destroy cancer cells.

mFOLFIRINOX is a combination of chemotherapy drugs used to treat cancer. It includes several different medications that work together to stop cancer cells from growing and dividing. This treatment is often used to help shrink tumors and slow down the progression of the disease.

Pancreatic ductal adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas, which is an organ located behind the stomach. It typically starts when cells in the pancreatic ducts develop mutations in their DNA, causing them to grow uncontrollably and form a tumor. As the disease progresses, the tumor can invade nearby tissues and organs, such as the stomach, liver, and intestines. It may also spread to distant parts of the body through the bloodstream or lymphatic system. The disease often grows silently, with symptoms appearing only after it has advanced. Common symptoms include jaundice, weight loss, and abdominal pain.

Trial ID:

2022-502404-73-00

Protocol code:

GO44479

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Autogene Cevumeran, Atezolizumab, and mFOLFIRINOX in Patients with Resected Pancreatic Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?