Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer
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.