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

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Composite Endpoint: Proportion of Patients With at Least One Occurrence of a Safety or Feasibility Event	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 Outcome Measures

Name	Time	Method
Pathologic Response (PR)	Up to 91 days after drug administration.	At least 50% or more tumor regression classified as per Mandard tumor regression grading system, in viable adenocarcinoma cells in the surgical specimen, including lymph nodes. Pathological response includes complete pathology response (CR), near complete pathological response (near CR) and partial pathological response
Time From Administration of Trial Treatment to Surgery	Up to 91 days after drug administration.	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.
Radiographic Response Rate	Up to 91 days after drug administration.	Radiographic response on pre-surgical imaging, following receipt of the neoadjuvant therapy, as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). The same imaging procedure(s) (computed tomography, magnetic resonance imaging scan) were used throughout the trial.