https://pittplusme.org/study/995
UPCI 15-066: Pembrolizumab (Keytruda®) + MGA271 for Advanced or Metastatic Cancers
STUDY BASICS
Have you been diagnosed with advanced or metastatic cancer of the lung, colon, prostate, head and neck, kidney, ovary, bladder, thyroid, pancreas, or breast; or advanced or metastatic mesothelioma, sarcoma, or melanoma? You may be able to take part in a research study to help test the dosage, safety, and effectiveness of a combination of pembrolizumab (Keytruda®) and an investigational drug.
STUDY PURPOSE
Advanced cancers that are metastatic (have spread to other parts of the body) or unresectable (cannot be completely removed by surgery) can be difficult to treat. The purpose of this study is to learn more about the dosage and side effects, safety, and effectiveness of an investigational drug called MGA271 given in combination with pembrolizumab (Keytruda®) for certain types of cancers, and to also see if this combination may be a potential treatment for certain cancers in the future. MGA271 and pembrolizumab (Keytruda®) are part of a class of drugs known as monoclonal antibodies that work with the body’s immune system. Researchers hope the combination of MGA271 and pembrolizumab (Keytruda®) will help direct the body’s immune system to target and attack cancer cells. MGA271 has not been approved by the FDA. Pembrolizumab (Keytruda®) is approved by the FDA for treatment of melanoma, non-small cell lung cancer, and squamous head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma and microsatellite instability-high cancer, but is considered an investigational drug for all other cancers.COULD THIS STUDY BE RIGHT FOR YOU?
- Ages 18 and up
- Diagnosed with advanced or metastatic mesothelioma, non-small cell lung cancer, squamous cell cancer of the head and neck, clear cell renal (kidney) cancer, ovarian cancer, melanoma, thyroid cancer, triple-negative breast cancer, pancreatic cancer, colon cancer, soft tissue sarcoma, prostate cancer or urothelial (bladder, ureter, urethra, or part of the kidney) cancer
- Stopped other treatments such as surgery, chemotherapy, and other test drugs at least 4 weeks before study enrollment
WHAT PARTICIPANTS CAN EXPECT
Participation lasts up to 3 years. During an initial visit to find out if you are eligible for the study and throughout the course of the study, you will have blood and urine tests, electrocardiograms (ECG) to test your heart rhythm, CT or MRI scans, and other tests and assessments as needed. Some participants will also have a tumor biopsy. All participants who qualify for the study will receive MGA271 and pembrolizumab (Keytruda®) by infusion for up to 1 year, and will have two years of follow up.IRB: 20151677
- A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination with Pembrolizumab in Patients with Melanoma, Squamous Cell Cancer of the Head and Neck, Non-Small Cell Lung Cancer, Urothelial Cancer, and Other Cancers
MEET THE RESEARCHER
Robert Ferris
Robert L. Ferris, MD, PhD is the Director of UPMC Hillman Cancer Center and Chief of the Division of Head and Neck Oncologic Surgery in the Departments of Otolaryngology and of Immunology. Certified by the American Board of Otolaryngology, he treats patients with benign and malignant tumors of the head and neck, including the thyroid and salivary glands, oral cavity, throat and voice box (larynx). He regularly performs endoscopic, minimally invasive approaches to thyroidectomy and partial laryngectomy, in order to preserve function and speed the return of speaking, swallowing and breathing.
Dr. Ferris is also developing and implementing immunotherapy (cancer vaccines) to treat head and neck tumors. His research focus is in trying to understand how to stimulate the body's immune system to eliminate cancer. The goals of this research are to boost the body's immune response against cancer and to try to prevent cancer from recurring (or to prevent it from occurring in the first place).
Dr. Ferris was trained at Johns Hopkins, where he received his medical degree and PhD in Immunology, a residency in Otolaryngology/Head and Neck Surgery, and subspecialty training in head and neck oncologic surgery. He is presently the President-elect of the Pennsylvania Academy of Otolaryngology/Head and Neck Surgery.