Phase IB Study of Pembrolizumab (MK-3475) in Subjects With Select Advanced Solid Tumors

Trial ID #	NCT02054806; KEYNOTE-028
Phase	I
Drug Class	Immunotherapy: Checkpoint Inhibitors/PD-1
Drug Name	Pembrolizumab
Alternate Drug Names	Keytruda, Lambrolizumab, SCH 900475, MK3475, MK-3475
Drugs in Trial	Pembrolizumab
Eligible Participant	Recurrent, refractory PD-L1-positive ovarian cancer
Patients Enrolled	440 (26 ovarian)
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, PFS, OS, evaluated per RECIST
Biomarkers	PD-L1 protein
Efficacy	ORR: 12% (1CR, 2PR, n=26) DCR: 35% (1CR, 2PR, 6SD, n=26) PFS: 1.9 months (1.8-3.5) OS: 13.1 months (6.7-18.8)
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: elevated transaminase levels (1/26)
Conclusion	Encouraging anti-tumor activity with acceptable safety profile
Reference	Varga A et al. Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028. Gynecol Oncol (2019) 152(2):243-250 https://www.ncbi.nlm.nih.gov/pubmed/30522700