Clinical Trials Search
Clinical Trial 18393
Interventions:MGA271; Pembrolizumab (Keytruda)
Study Type: Treatment
Phase of Study: Phase I
- Scott Antonia
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 Squamous Cell Non-Small Cell Lung Cancer
The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), and other B7-H3 expressing cancers. The study will also evaluate what is the highest dose of enoblituzumab that can be given safely when given with pembrolizumab. Assessments will also be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity of MGA271 in combination with pembrolizumab.
The primary objective of this study is to characterize the safety, tolerability, dose-limiting toxicities (DLT), andmaximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of MGA271when administered intravenously (IV) weekly in combination with 2 mg/kg pembrolizumab administered IV every 3 weeks to patients with B7-H3 expressing, unresectable locally-advanced or metastatic melanoma,SCCHN, or squamous cell NSCLC.