Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT06959550
Brief Summary:
The goal of this clinical research study is to learn if ivonescimab can help to control previously treated, metastatic colorectal cancer.
Detailed Description:
Primary Objective:
• To evaluate the efficacy of ivonescimab, as determined by the objective response rate per iRECIST, in three distinct cohorts of patients with treatment-refractory metastatic colorectal cancer: 1) dMMR/MSI-H refractory to anti-PD-1 therapy, 2) pMMR/MSS without liver metastases, and 3) pMMR/MSS with liver metastases.
Secondary Objective:
* To evaluate the safety of ivonescimab in patients with metastatic colorectal cancer.
* To evaluate the efficacy of ivonescimab, as determined by the objective response rate per RECIST 1.1, in three distinct cohorts of patients with treatment-refractory metastatic colorectal cancer: 1) dMMR/MSI-H refractory to anti-PD-1 therapy, 2) pMMR/non-MSI-H without liver metastases, and 3) pMMR/non-MSI-H with liver metastases.
* To evaluate changes in intratumoral CD8+ T cell density following ivonescimab therapy.
Exploratory Objectives:
* To assess the time to response following treatment with ivonescimab in patients with metastatic colorectal cancer.
* To assess the durability of response following treatment with ivonescimab in patients with metastatic colorectal cancer.
* To evaluate progression-free survival following treatment with ivonescimab in patients with metastatic colorectal cancer.
* To evaluate overall survival following treatment with ivonescimab in patients with metastatic colorectal cancer.
* To investigate clinical, pathologic, and molecular features associated with therapeutic response to ivonescimab in patients with metastatic colorectal cancer.
* To investigate changes in immune cell composition and distance relationships within the metastatic CRC tumor microenvironment following ivonescimab therapy.
* To evaluate changes in peripheral immune cell populations in metastatic CRC patients following ivonescimab therapy.
Study:
NCT06959550
Study Brief:
Protocol Section:
NCT06959550