Full TitleNon-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects with Virus-Positive and Virus-Negative Solid Tumors (Version 4 Date: 28-OCT-2016)
Nivolumab is an immunotherapy drug used to treat several types of cancer. It boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this shut-down mechanism by activating PD-1, enabling them to escape attack by the body’s white blood cells. Nivolumab binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.
In this study, researchers are assessing the safety and effectiveness of nivolumab when given before surgery in patients with operable Merkel cell skin cancer and squamous cell cancers of the head and neck. Two doses of nivolumab will be given intravenously (by vein) before surgery.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have operable Merkel cell cancer or squamous cell cancer of the head and neck.
- At least 4 weeks must pass between the completion of prior therapies and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.