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Botensilimab + Chemotherapy for Pancreatic Cancer
Study Summary
This trial tests if adding a new drug to chemo helps fight metastatic pancreatic cancer better than chemo alone.
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 not received a COVID-19 vaccine in the week before starting the study drugs.I have had more than one treatment for my metastatic disease.I have been treated with drugs that boost the immune system.I have not had major surgery in the last 4 weeks.I have an uncontrolled HIV infection.I have had a bowel blockage or symptoms of one in the last 3 months.I do not have any uncontrolled illnesses like serious heart conditions.My cancer has spread to my brain or spinal cord.I have ongoing diarrhea worse than mild, despite treatment.My diagnosis is pancreatic cancer confirmed by tissue analysis.I have active or latent tuberculosis.My organs are working well.I do not have another cancer needing treatment or any cancer active in the last 2 years.I haven't needed treatment for an autoimmune disease in the last 2 years.I have active hepatitis C confirmed by tests.I rely on nutrition given through my veins.I am a woman who can have children and have a negative pregnancy test.My nerve damage symptoms are mild or non-existent.I agree to use effective birth control during the study.My cancer has worsened despite FOLFIRINOX treatment.I haven't taken any cancer drugs or participated in a drug study in the last month.I have a lung condition that could affect new lung toxicity detection.I had a mild or no symptom COVID-19 infection less than 10 days ago, or a severe one less than 20 days ago.My blood clotting levels are within a safe range.I have serious stomach or intestine problems.I haven't taken high-dose steroids or immunosuppressants recently.I haven't needed IV drugs for an infection in the last 2 weeks.My condition causes fluid buildup in my abdomen that treatments do not help.I am fully active or can carry out light work.
- Group 1: Part 1: Combination (Safety Lead-in Phase)
- Group 2: Part 2: Combination
- Group 3: Part 2: Standard of Care
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 the research currently recruiting participants?
"Indeed, per clinicaltrials.gov this experiment is actively searching for participants to take part in the study which was published on December 1st 2022 and went through its latest update on December 22nd of that year."
In what geographic areas is this clinical trial currently being conducted?
"This trial has 14 potential sites for enrollment, including the USC Norris Comprehensive Cancer Center in Los Angeles and Georgetown Lombardi Comprehensive Cancer Center in Washington. Additionally, The Centre for Cancer and Blood Disorders in Bethesda is one of many other locations offering participation."
Has Part 1: Combination (Safety Lead-in Phase) been given the required authorization by the FDA?
"Our assessment of Part 1: Combination (Safety Lead-in Phase) safety rating is a 2, denoting that there are some data available to affirm its security profile but no efficacy documentation yet."
How many individuals have been inducted into this trial so far?
"Affirmative. According to information on clinicaltrials.gov, this medical study is still enrolling patients, having been originally posted on December 1st 2022 and updated most recently on the 22nd of that month. A total of 78 participants are being sought from 14 sites in order for it to be successful."
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