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

Part of paid clinical trials in New York, New York.

Sponsor
Boehringer Ingelheim
Study ID
NCT05446129
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ezabenlimab — DRUG
    Ezabenlimab
  • BI 765063 — DRUG
    BI 765063
  • Pembrolizumab — DRUG
    Pembrolizumab

Study Details

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.

Key Dates

Start date
Sep 27, 2022
Status verified
Mar 2025
Primary completion
Aug 11, 2023
Completion
Nov 8, 2023

Study Design

Enrollment
2 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Ezabenlimab + BI 765063
  • Experimental: Cohort B: Pembrolizumab + BI 765063

Primary Outcome Measure

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai School of MedicineNew YorkNew York10029-

Related coverage on Hipa.ai

Find similar trials in New York, NY

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Mount Sinai School of Medicine· New York, NY

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