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Chemotherapy
Autogene Cevumeran + Atezolizumab + Chemotherapy for Pancreatic Cancer (IMCODE003 Trial)
Phase 2
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up years 3 and 5
Awards & highlights
IMCODE003 Trial Summary
This trial evaluates the safety & efficacy of a combo treatment for pancreatic cancer after surgery to see if it's better than a single treatment.
Who is the study for?
This trial is for adults with resected pancreatic ductal adenocarcinoma who haven't had prior cancer treatments and show no signs of disease post-surgery. They must have certain pathology stages, recovered from surgery, normal organ function, and agree to contraception.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of adding autogene cevumeran and atezolizumab to mFOLFIRINOX chemotherapy compared to mFOLFIRINOX alone in patients after surgical removal of pancreatic cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation, gastrointestinal issues from chemotherapy (like nausea or diarrhea), increased risk of infections, blood cell count changes, fatigue, and possible allergic reactions.
IMCODE003 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ years 3 and 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~years 3 and 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Free Survival (DFS)
Secondary outcome measures
DFS Rates at 12, 24, and 36 Months
OS Rates at 3 and 5 Years
Overall Survival (OS)
+1 moreIMCODE003 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOXExperimental Treatment3 Interventions
Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
Group II: Arm 2: mFOLFIRINOXActive Control1 Intervention
Participants will receive mFOLFIRINOX.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mFOLFIRINOX
2013
Completed Phase 2
~40
Atezolizumab
2017
Completed Phase 3
~5860
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Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,541 Previous Clinical Trials
567,883 Total Patients Enrolled
BioNTech SEIndustry Sponsor
64 Previous Clinical Trials
107,438 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,680 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis of pancreatic cancer is confirmed through tissue examination.It has been 6 to 12 weeks since my pancreatic cancer surgery.I have had initial treatment for pancreatic cancer.My pancreatic cancer was completely removed with surgery.My blood and organs are functioning well.I do not have a spleen and have not had a distal pancreatectomy with splenectomy.My doctor confirmed I have no signs of cancer after surgery.I have or had an autoimmune disease or immune deficiency.My pancreatic cancer is in the early or middle stages, without distant spread.I have fully recovered from surgery and can receive specific cancer treatments as per my doctor's judgment.I will avoid fathering a child or donate sperm during and for 6 months after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
- Group 2: Arm 2: mFOLFIRINOX
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned a combination of Autogene Cevumeran, Atezolizumab and mFOLFIRINOX for Arm 1?
"Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX obtained a score of 2 since Phase 2 trials have only provided evidence regarding the safety but not efficacy."
Answered by AI
What is the enrollment size of this medical study?
"Affirmative, the information on clinicialtrials.gov implies that this clinical trial is in search of volunteers. It was initially posted at 22nd July 2023 and subsequently updated on 21st July 2023. This study requires 260 individuals to be recruited from 1 centre."
Answered by AI
Is this research initiative recruiting participants?
"Indeed, the information found on clinicaltrials.gov demonstrates that this medical trial is actively recruiting participants. This experiment was initially published on July 22nd 2023 and last updated on July 21st 2023. The study requires 260 volunteers from one location to be enrolled in order for it to continue forward."
Answered by AI
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