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RecruitingPHASE2INTERVENTIONAL

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

This research study is for people who have had pancreatic cancer surgery and have no signs of cancer left. The aim is to find out if a new combination of treatments is better and safer than the current standard treatment. Participants will be divided into two groups: one receiving a new approach that combines Autogene Cevumeran, Atezolizumab, and mFOLFIRINOX, and another receiving mFOLFIRINOX on its own. Researchers will carefully watch how well these treatments work to prevent the cancer from coming back and what side effects people experience. The goal is to improve care for pancreatic cancer patients after successful surgery.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Genentech, Inc.
Enrolment target
260
Start
18 Oct 2023
Estimated completion
01 Jan 2031

What is this study about?

This study is for patients who have recently had surgery to remove a type of pancreatic cancer called pancreatic ductal adenocarcinoma (PDAC). After surgery, some cancer cells might still be in the body, even if they can't be seen. The aim of this study is to stop the cancer from coming back.

Currently, a chemotherapy treatment called mFOLFIRINOX is often used after surgery. This study wants to see if adding two new drugs, Autogene Cevumeran and Atezolizumab, to mFOLFIRINOX works better and is just as safe as mFOLFIRINOX on its own. Autogene Cevumeran is like a special vaccine that helps your body’s immune system learn to fight cancer cells, while Atezolizumab is another type of immune treatment that helps your immune system work more effectively against cancer.

By comparing these two treatment approaches, the researchers hope to find a more effective way to prevent the cancer from returning after surgery, giving patients a better chance at a long, healthy life. Every treatment will be carefully monitored for both its effectiveness and any side effects.

Key takeaways

  • This study is for adults whose pancreatic cancer was fully removed by surgery.
  • It compares standard chemotherapy with chemotherapy plus two new immune-boosting drugs.
  • The goal is to find better ways to stop pancreatic cancer from coming back.
  • You will receive careful monitoring and support throughout the study.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have recently had surgery for pancreatic cancer. Specifically, your doctor must have confirmed that all visible cancer was removed during the operation, and tests show no remaining signs of the disease afterwards. You also cannot have received any previous treatment for your pancreatic cancer, like chemotherapy, before joining this study.

To be considered, you'll need to have had your surgery between 6 and 12 weeks before starting the study treatment, and you must have recovered well enough from the operation to receive further treatments. Your body also needs to be in good working order, with healthy blood counts and organ function.

There are also some reasons why you might not be able to join. For example, if you've already had any anti-cancer treatment for your pancreatic cancer, or if you had your spleen removed during your pancreatic surgery. Also, if you have a certain nerve condition (neuropathy) or a specific genetic condition affecting how your body handles some drugs, you wouldn't be able to participate. Women must agree to avoid pregnancy during and for some time after the study, and men must use contraception if their partner could become pregnant.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Have I had pancreatic cancer (PDAC) surgery where all visible cancer was removed?
  2. Have I fully recovered from my surgery?
  3. Have I had no other anti-cancer treatments for my pancreatic cancer before now?
  4. Am I willing to use contraception if I or my partner could become pregnant?
  5. Am I over 18 years old?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two treatment groups: either the new combination of treatments (Autogene Cevumeran, Atezolizumab, and mFOLFIRINOX) or the standard mFOLFIRINOX treatment alone. You will receive these treatments over a period of time, usually given through a drip at a clinic.

You will have regular appointments and tests throughout the study. These will include blood tests to check your general health and levels of a specific marker (CA19-9), and scans to ensure the cancer has not returned. There will also be check-ups to monitor how you are feeling and to record any side effects you might experience. After your main treatment period finishes, you will continue to have follow-up appointments and checks to see how you are doing in the long term. The total duration of your participation, including follow-up, will be determined by the study plan, but some follow-up might continue for several years.

Potential risks and benefits

Participating in a clinical trial offers some potential benefits, such as receiving close medical care and potentially having access to new treatments that might be more effective than standard options. However, there are also potential risks, as the new treatments may have side effects that are not fully known or could be more severe than existing treatments. We cannot guarantee that you will personally benefit from taking part. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (89)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • USC Norris Comprehensive Cancer Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • USC Norris Cancer Center
    Verified postcode
    Newport Beach, United States· Recruiting
  • University of California, San Francisco (UCSF)
    Verified postcode
    San Francisco, United States· Recruiting
  • University of California Los Angeles
    Verified postcode
    Santa Monica, United States· Recruiting
  • St. Francis Hospital and Medical Center
    Verified postcode
    Hartford, United States· Recruiting
  • Smilow Cancer Center
    Verified postcode
    New Haven, United States· Withdrawn
  • Yale Cancer Center
    Verified postcode
    New Haven, United States· Recruiting
  • Smilow Cancer Hospital Care Center at Trumbull
    Verified postcode
    Trumbull, United States· Recruiting
  • Northwestern Memorial Hospital
    Verified postcode
    Chicago, United States· Recruiting
  • Indiana University Health Melvin & Bren Simon Cancer Center
    Verified postcode
    Indianapolis, United States· Recruiting
  • University of Kentucky Medical Center
    Verified postcode
    Lexington, United States· Recruiting
  • Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center
    Verified postcode
    Boston, United States· Recruiting

Common questions

What is pancreatic ductal adenocarcinoma (PDAC)?

PDAC is the most common type of pancreatic cancer that starts in the ducts of the pancreas.

What does 'resected' mean?

Resected means that the tumour has been surgically removed from your body.

What is mFOLFIRINOX?

mFOLFIRINOX is a standard combination of chemotherapy drugs often used to treat pancreatic cancer.

What are Autogene Cevumeran and Atezolizumab?

These are newer types of treatments that work with your body's immune system to fight cancer cells.

Will I know which treatment I'm receiving?

You will be told which treatment group you are in after you join the study.

How to find out more

Reference Study ID Number: GO44479 https://forpatients.roche.com/

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of the Efficacy and Safety of Adjuvant Autogene Cevu…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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