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Monoclonal Antibodies
Cohort A: Ezabenlimab + BI 765063 for Colorectal Cancer
Phase 1
Waitlist Available
Research Sponsored by Boehringer Ingelheim
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 up to 91 days
Awards & highlights
Study Summary
This trialtests medicines to see if they help people with newly diagnosed colorectal cancer in preparation for surgery. Participants get either ezabenlimab/BI 765063 combo or pembrolizumab/BI 765063 combo & monitored for 4 months.
Eligible Conditions
- Colorectal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 91 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 91 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite endpoint: Proportion of patients with at least one occurrence of a safety or feasibility event
Secondary outcome measures
Pathological response
Radiographic response on pre-surgical imaging, following receipt of the neoadjuvant therapy, as per response evaluation criteria in solid tumors (RECIST) v1.1
Time from administration of trial treatment to surgery, defined as the time in days that elapses between administration of neoadjuvant trial therapy and surgical resection
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: Pembrolizumab + BI 765063Experimental Treatment2 Interventions
Group II: Cohort A: Ezabenlimab + BI 765063Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 765063
2020
Completed Phase 1
~20
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,572 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received treatment with immune checkpoint inhibitors in the past.You have advanced cancer that has spread or come back, and surgery cannot cure it.Your doctor thinks you have a high chance of experiencing a blockage or tear in your colon.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Ezabenlimab + BI 765063
- Group 2: Cohort B: Pembrolizumab + BI 765063
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.
What is the FDA's decision on cohort A's use of ezabenlimab in addition to BI 765063?
"Because this is an early-stage trial, there is limited safety and efficacy data for Cohort A: Ezabenlimab + BI 765063. Our team has given it a conservative safety estimate of 1."
Answered by AI
Are investigators looking for new participants in this trial right now?
"This study, as indicated by clinicaltrials.gov, is currently looking for enrollees. The listing for this clinical trial was first made on September 27th, 2022 and was most recently updated on October 10th, 2022."
Answered by AI
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