A Phase II Study of Pembrolizumab Combined With Pegylated Liposomal Doxorubicin (PLD) For Recurrent Platinum Resistant Ovarian, Fallopian Tube Or Peritoneal Cancer

Trial ID # NCT02865811
Phase II
Drug Class Immunotherapy: Checkpoint Inhibitors/PD-1
Drug Name Pembrolizumab
Alternate Drug Names MK3475, SCH 900475, Lambrolizumab, Keytruda
Drugs in Trial Liposomal doxorubicin, Pembrolizumab
Eligible Participant

Recurrent platinum-resistant ovarian cancer; ≤ 3 prior therapies

Patients Enrolled

26; median 2 prior therapies (1-3)

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, DoR, RP2D

Efficacy

RP2D: PLD 40 mg/m2 IV every 4 weeks + Pem 200 mg IV every 3 weeks

ORR: 19% (5 PR, n=26)
DCR: (6 months): 42% (5PR, 6SD, n=26)
DoR: 4.1 months (2.3-8)

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: anemia (12%), rash (12%), increased liver enzymes (12%)

Conclusion

Encouraging anti-tumor activity with acceptable safety profile

Reference

Matulonis UA et al. Phase II study of pembrolizumab (pembro) combined with pegylated liposomal doxorubicin (PLD) for recurrent platinum-resistant ovarian, fallopian tube or peritoneal cancer. SGO (2018) abstract 48
https://www.sgo.org/wp-content/uploads/2018/03/Abstracts-2018-SGO-Annual-Meeting-on-Womens-Cancer-1.pdf