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ABBV-927 + Budigalimab + mFOLFIRINOX for Pancreatic Cancer
Study Summary
This trial will help researchers learn if the investigational drugs are safe and effective for treating Metastatic Pancreatic Cancer Disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have significant fluid buildup in my body.I have a neuroendocrine or acinar pancreatic cancer diagnosis.I have another cancer type but it's under control and doesn't need treatment.I have had treatment for metastatic pancreatic cancer.I have another cancer type but it's under control and doesn't need treatment.I have had radiation therapy on a cancer spot that can be measured.My cancer has spread to nearby tissues but not distant parts of the body.You have a measurable tumor according to specific medical guidelines.My cancer has spread to my brain or spinal cord.My body weight is at least 35 kg.My body weight is at least 35 kg.I haven't had cancer treatment or surgery in the last 4 months.My cancer is a type of pancreatic cancer that has spread to other parts of my body.You have a detectable tumor that can be measured according to specific guidelines.
- Group 1: Phase 2 Cohort B
- Group 2: Phase 2 Cohort C Expansion
- Group 3: Phase 1b Dose Escalation
- Group 4: Phase 2 Cohort A
- 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
Is it currently possible to sign-up for this experiment?
"That is correct. The listing on clinicaltrials.gov reveals that the research team is actively recruiting patients for this trial. 129 subjects are needed in total, with 10 different hospitals participating."
What is the current FDA stance on modified FOLFIRINOX?
"There is some clinical data suggesting that modified FOLFIRINOX is safe, but none yet attesting to its efficacy. Consequently, it received a score of 2."
By what means does this research plan to achieve its objectives?
"The primary outcome that will be measured over a 6-month period is overall survival. Additionally, this trial will also assess secondary outcomes including time to maximum observed plasma concentration (Tmax), objective response rate (ORR), and clinical benefit rate (CBR)."
Could elderly patients over the age of 60 still be eligible for this clinical trial?
"As this study requires, participants must be between 18-75 years old."
How many hospitals are running this trial?
"To limit participant inconvenience, the 10 enrolling centres for this study are localised. If you wish to take part in this research, please choose the clinic nearest to your residence from Cleveland, Springdale, Kettering or the other 10 locations."
Are there any other investigations that have looked at modified FOLFIRINOX?
"There are 210 clinical trial sites for modified FOLFIRINOX with seven of them being active. Most of the research for this procedure is based in Hamburg and Lazio."
How many individuals are currently involved in this clinical trial?
"That is correct, the trial is still actively looking for patients. According to the listing on clinicaltrials.gov, the original posting was on May 28th, 2021 and there have been edits as recently as May 23rd, 2022. They are hoping to find 129 people total from 10 different locations."
What is the unique aspect of this clinical trial?
"Since 2018, modified FOLFIRINOX has been the subject of clinical research studies. The very first one was sponsored by AbbVie and took place in that same year. This initial study had 233 participants. Based on the success of this Phase 1 trial, the drug was approved for public use. As of now, there are 7 ongoing trials involving modified FOLFIRINOX being conducted in 13 different countries and 99 cities total."
If I wanted to, how could I sign up for this clinical research?
"129 patients are being recruited for this clinical trial that requires participants to have cancer of the pancreas and be between 18-75 years old."
Who else is applying?
What state do they live in?
How old are they?
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What portion of applicants met pre-screening criteria?
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