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


Study Design

Open-Label, Non-randomized


ORR, DCR, PFS, OS, evaluated per RECIST


PD-L1 protein


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)


Encouraging anti-tumor activity with acceptable safety profile


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

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