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J1365: Phase 2 Study of MK-3475 in Patients with Microsatellite Unstable (MSI) Tumors
Protocol Number:
Phase II
Dung Le
Johns Hopkins Kimmel Cancer Center in Baltimore
To determine the immune-related progression free survival rate and objective response rate in patients with MSI positive and negative colorectal adenocarcinoma treated with MK-3475, and the progression free survival rate in patients with MSI positive non-colorectal adenocarcinoma treated with MK-3475.
1. Patients with histologically proven metastatic or locally advanced MSI or MSS colorectal adenocarcinoma, or non-colorectal MSI adenocarcinoma. 2. Measurable disease. 3. Normal organ and marrow function. 4. Has not received any anti-cancer therapy in the past 14 days or investigational agents in past 28 days.
The PD-1 receptor-ligand interaction is a major pathway used by tumors to suppress immune control. MK-3475 is a potent monoclonal antibody designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Patients will be assigned to one of three cohorts, depending upon disease and MSI status. Patients will receive MK-3475 on day 1 of a 14-day cycle and will be followed closely with physical assessment, blood draws, scans and biopsies.
Last Update
08/11/2020 05:02 AM