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Study Summary
This trial will test if aplitibart in combination with FOLFIRI chemotherapy and bevacizumab is safe and effective in treating colorectal cancer that has relapsed or spread.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
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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- I am 18 years old or older.I haven't taken any cancer treatment except chemotherapy or SMI in the last 4 weeks.My cancer is advanced or has spread and cannot be cured.My liver, kidneys, and bone marrow are working well.I am eligible for chemotherapy or targeted therapy as part of my treatment plan.I have had 3 or fewer treatments for my condition.
- Group 1: Ph1b: Bevacizumab + FOLFIRI
- Group 2: Ph1b: Aplitibart + FOLFIRI + Bevacizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 4 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 36 Months after you stop receiving the treatment.
Frequently Asked Questions
Can I participate in this clinical trial while receiving other treatments?
"No, if you participate in this trial you may not receive any other treatment for your cancer as long as you are on the trial."
Can I leave this clinical trial if I change my mind or experience side effects?
"Yes you can leave a clinical trial at any time."
How long will I be required to participate in this clinical trial?
"There is no time requirement. You will be asked to continue to participate in this trial until your cancer worsens"
What if I require support for travel and accommodation to participate in the study?
"You will be reimbursed for your travel costs if you decide to participate in the study. You will also be provided support through a concierge service if you need assistance scheduling appointments."
How many people have been treated with aplitibart before me?
"More than 50 people have been treated with aplitibart."
Will I know what medication I'm taking?
"Your study doctor or study staff will tell you which treatment group you will be in and you will receive aplitibart in combination with the standard of care FOLFIRI with bevacizumab (or an approved biosimilar drug) OR you will receive standard of care FOLFIRI with bevacizumab (or an approved biosimilar drug)."
If I receive the standard of care arm without aplitibart, will I have the chance to ever receive aplitibart?
"Yes you will. If your disease worsens under standard of care, you will have a chance to receive aplitibart in combination with standard of care."
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