A Phase I Open Label Study to Assess Safety, Feasibility, Efficacy, and Biological Activity of Single Administration of Neoadjuvant Treatments Ezabenlimab in Combination With BI 765063 and Pembrolizumab in Combination With BI 765063 in Patients With Newly Diagnosed Surgically-resectable, Locoregional Colorectal Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Composite Endpoint: Proportion of Patients With at Least One Occurrence of a Safety or Feasibility Event
Study Overview
Brief Summary
This study is open to people with newly diagnosed colorectal cancer. People who are scheduled for surgery can participate. People either get a medicine called BI 765063 combined with ezabenlimab or combined with pembrolizumab in preparation of the upcoming surgery. The tested medicines in this study are antibodies that may help the immune system fight cancer.
The purpose of this study is to find out how well people with early colorectal cancer can tolerate treatment with these medicines. The study also looks at whether the tumor changes.
Participants are put into 2 groups. One group gets ezabenlimab and BI 765063. The other group gets pembrolizumab and BI 765063. All participants receive the study medicines as 2 subsequent infusions into a vein on a single day.
Participants are in the study for about 4 months. During this time, they visit the study site about 5 times. The doctors check the health of the participants and note any health problems that could have been caused by ezabenlimab, pembrolizumab, or BI 765063. The doctors also check whether these health problems lead to a delay of the planned surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort A: Ezabenlimab + BI 765063
Intervention: Ezabenlimab (Drug)
Cohort A: Ezabenlimab + BI 765063
Intervention: BI 765063 (Drug)
Cohort B: Pembrolizumab + BI 765063
Intervention: BI 765063 (Drug)
Cohort B: Pembrolizumab + BI 765063
Intervention: Pembrolizumab (Drug)
Outcomes
Primary Outcomes
Composite Endpoint: Proportion of Patients With at Least One Occurrence of a Safety or Feasibility Event
Time Frame: Up to 91 days after drug administration.
Safety: A safety event was defined as any grade 3 or higher adverse events (AEs; according to National Cancer Institute's Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) related to study treatments at any point within the follow-up period following the administration of study treatments. Feasibility (delay in surgery): A feasibility event or delay in surgery was defined as any treatment related AE leading to delay in surgery, which was scheduled to take place between 2 weeks and up to 6 weeks following the study treatment administration will be considered as a relevant AE for this endpoint.
Secondary Outcomes
- Pathologic Response (PR)(Up to 91 days after drug administration.)
- Time From Administration of Trial Treatment to Surgery(Up to 91 days after drug administration.)
- Radiographic Response Rate(Up to 91 days after drug administration.)