Recurrent Colorectal Carcinoma Clinical Trial
Official title:
A Phase Ib/II Study of Cetuximab and Pembrolizumab in Metastatic Colorectal Cancer
This phase I/II trial studies the side effects and best dose of cetuximab when given together with pembrolizumab in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body (metastatic) or that cannot be removed by surgery. Monoclonal antibodies, such as cetixumab and pembrolizumab, may block tumor growth in different ways by targeting certain cells.
PRIMARY OBJECTIVES: I. To estimate the objective response rate of patients with metastatic colorectal cancer treated with pembrolizumab and cetuximab. II. To estimate the 6-month progression free survival (PFS) rate of patients with metastatic colorectal cancer treated with pembrolizumab and cetuximab. III. To examine the adverse event profile of combining pembrolizumab and cetuximab. SECONDARY OBJECTIVES: I. To examine the PFS of patients with metastatic colorectal cancer treated with pembrolizumab and cetuximab. II. To determine the objective response rate by immune-related response criteria (irRC) of patients with metastatic colorectal cancer. III. To examine the overall survival of patients with metastatic colorectal cancer treated with pembrolizumab and cetuximab. EXPLORATORY OBJECTIVES: I. Identify tumor and peripheral blood biomarkers of response and/or resistance to the study treatment. OUTLINE: Patients receive cetuximab intravenously (IV) over 120 minutes on day 1, 8, and 15 (as monotherapy for cycle 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression. After completion of the study treatment, patients are followed up every 3 months for up to 2 years. ;
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