A Phase 1, Open Label, Dose Escalation Study of MGA271 in Combination with Pembrolizumab in Patients with B7-H3-Expressing Melanoma, Squamous Cell Cancer of the Head and Neck, or Non- Small Cell Lung Cancer

Protocol: 
AAAP4013
Phase: 
I

A Phase 1, Open Label, Dose Escalation Study of MGA271 in Combination with Pembrolizumab in Patients with B7-H3-Expressing Melanoma, Squamous Cell Cancer of the Head and Neck, or Non- Small Cell Lung Cancer

This study involves research about MGA271 in combination with Keytruda. MGA271 targets cancer cells that make a lot of a protein called B7-H3. Another way to say it is that the cells overexpress the protein. Very few normal cells express B7-H3. MGA271 is thought to work by recognizing cancer cells that overexpress B7-H3 and directing the body’s immune system to kill those cells. Keytruda works in a different way. Some cancer cells hide from the immune system's attack by taking control of what is called the PD-1 pathway. Keytruda works by blocking the PD-1 pathway allowing the immune system to recognize and attack the expressing cancer cells. The combination of MGA271 and Keytruda may help the immune system to better recognize and destroy tumor cells. This study will be designed in two parts. The first part is designed to determine the best amount of the drug to be given. The second part is designed to use the dose that was determined in the first part and test the drug on a larger amount of individuals and see if the drug in combination with Keytruda can be effective as a treatment in breast cancer.

Are you Eligible? (Inclusion Criteria)

1. Ability to provide informed consent and documentation of informed consent
prior to initiation of any study related tests or procedures that are not part of
standard-of-care for the patient's disease. Patients must also be willing and
able to comply with study procedures, including the acquisition of specified
research specimens.
2. Age >= 18 years old.
3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Life expectancy >= 12 weeks

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States