Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MacroGenics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
To enroll on cohorts 1-4, participants must have a histologically-proven, previously treated, unresectable, locally advanced or metastatic mesothelioma, urothelial cancer, thyroid cancer, pancreatic cancer, ovarian cancer, colon cancer, prostate cancer, soft tissue sarcoma, triple negative breast cancer, renal clear cell cancer, melanoma, squamous cell cancer of the head and neck, or non-small cell lung cancer.
Participants on the melanoma cohort must have progressed on or after at least one anti-PD-L1 or anti- PD-1 containing therapy.
Participants on the SCCHN cohort must have progressed on or after platinum-based systemic therapy
Participants on the NSCLC cohort must have progressed on or after first line systemic therapy
Participants on the urothelial cancer cohort must have received at least one platinum-containing regimen and have progressed on or after an anti-PD-L1 or anti-PD-1 containing therapy
Measurable disease per RECIST 1.1 criteria
Easter Cooperative Oncology Group (ECOG) performance status 0 or 1
Acceptable laboratory parameters and adequate organ reserve.
You may not be if
Patients with a history of symptomatic central nervous system metastases, unless treated and asymptomatic
Patients with history of autoimmune disease with certain exceptions such as vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic therapy within the past 2 years, patients with history of Grave's disease that are now euthyroid clinically and by lab testing
History of allogeneic bone marrow, stem cell, or solid organ transplant
Treatment with systemic cancer therapy or investigational therapy within 4 weeks of first study drug administration; radiation within 2 weeks; corticosteroids (greater than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive drugs within 2 weeks of first study drug administration
Trauma or major surgery within 4 weeks of first study drug administration
History of clinically-significant cardiovascular disease; gastrointestinal perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4 weeks of first study drug administration
Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days of first study drug administration
Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction (PCR)
Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for MGA271 or pembrolizumab.
Clareo Health | Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer
