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AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma

2019-08-16 19:05:17 | BioPortfolio

Summary

This research is studying the safety and effectiveness of AMD3100 and pembrolizumab in participants with metastatic head and neck squamous cell carcinoma.

Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug combination works in treating a specific disease. "Investigational" means that the drug is being studied.

Because AMD3100 and Pembrolizumab have not been administered together to individuals before, there will be a Run-In phase prior to the beginning of Phase II. This Run-In Phase is designed to identify what dosing schedule is best for participants on this study. Participants will be participating in the Run-In Phase.

The U.S. Food and Drug Administration (FDA) has approved Pembrolizumab as a treatment option for this disease.

The FDA has not approved AMD3100 as a treatment option for this disease, however it has approved the drug for use in individuals who have recently had bone marrow transplants.

Pembrolizumab is thought to block a receptor called PD-1. This receptor usually acts as a "brake" to prevent the body's immune system from attacking cancer cells. The antibody "removes the brake" to allow parts of the body's immune system (usually T cells) to attack the tumor

AMD3100 is a drug that inhibits CXCR4, which is a biological mechanism called a chemokine. CXCR4 is over-expressed in cancer cells and promotes cancer cell growth, spread, and survival and controls immune cell trafficking. Researchers believe that inhibiting CXCR4 expels the immune-suppressive cells out of the tumor and attract the cancer-killing immune cells into the tumor environment so that the body's immune system may be able to better attack the cancer cells.

In this research study, the investigators are assessing the safety and effectiveness of AMD3100 and pembrolizumab in participants with aggressive head and neck squamous cell carcinoma.

Study Design

Conditions

Head and Neck Cancer

Intervention

AMD3100, Pembrolizumab

Location

Massachusetts General Hospital Cancer Center
Boston
Massachusetts
United States
02062

Status

Not yet recruiting

Source

Massachusetts General Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-08-16T19:05:17-0400

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