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Monoclonal Antibodies
A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery
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
No Placebo-Only Group
Summary
This trial is for people with newly diagnosed colorectal cancer who are about to have surgery. It tests two combinations of medicines that help the immune system fight cancer. The study aims to see if these medicines are safe and if they can shrink the tumor.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite endpoint: Proportion of patients with at least one occurrence of a safety or feasibility event
Secondary study objectives
Pathological response
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 3
~3150
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,551 Previous Clinical Trials
15,858,023 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.