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

Trial ID # NCT02054806
Phase I
Drug Class Immunotherapy: Checkpoint Inhibitors/PD-1
Drug Name Pembrolizumab
Alternate Drug Names MK3475, SCH 900475, Lambrolizumab, Keytruda
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 et al. Pembrolizumab in patients (pts) with PD-L1–positive (PD-L1+) advanced ovarian cancer: Updated analysis of KEYNOTE-028. J Clin Oncol (2017) 35 (suppl; abstr 5513)
https://meetinglibrary.asco.org/record/147401/abstract