NCT03085719

Targeting PD-1 Therapy Resistance With Focused High or High and Low Dose Radiation in SCCHN

Targeting PD-1 Therapy Resistance With Focused High or High and Low Dose Radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying immunotherapy in combination with radiation therapy as a possible treatment for head \& neck cancer that has worsened or spread to another organ or part of your body. The immunotherapy involved in this study is: MK-3475 (pembrolizumab or KEYTRUDA).

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the treatment works in treating a specific disease. "Investigational" means that the treatment is being studied. MK-3475 is a humanized monoclonal antibody. An antibody is a common type of protein made in the body in response to a foreign substance (particles not typically found in the body such as bacteria or viruses). Antibodies attack foreign substances and protect against infection. Antibodies can also be produced in the laboratory for use in treating patients. MK-3475 is designed to restore the natural ability of the immune system to recognize and target cancer cells. The FDA recently granted approval to MK-3475 as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This study is testing whether using radiation in combination with MK-3475 will make this drug work better in participants that might otherwise be unlikely to benefit from this drug because they have not responded to either this same drug given without radiation or another similar drug.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Keytruda is designed to restore the natural ability of the immune system to recognize and target cancer cells
RADIATION	Radiation	Radiation is used to shrink the cancer

Timeline

• Start date: 2017-06-30
• Primary completion: 2022-11-01
• Completion: 2027-10-31
• First posted: 2017-03-21
• Last updated: 2025-02-25
• Results posted: 2024-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study