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	Keytruda, Lambrolizumab, SCH 900475, MK3475, MK-3475
Drugs in Trial	Liposomal doxorubicin, Pembrolizumab
Eligible Participant	Platinum resistant ovarian cancer with ≤ 3 prior therapies
Patients Enrolled	26; median 2 prior therapies (1-3)
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	CBR, ORR, DoR, RP2D
Efficacy	RP2D: PLD 40 mg/m2 IV every 4 weeks + Pem 200 mg IV every 3 weeks ORR: 26.1% (1CR, 5PR, n=23) CBR: 52.2% (1CR, 5PR, 6SD, n=23) 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	Lee EK et al. Combined pembrolizumab and pegylated liposomal doxorubicin in platinum resistant ovarian cancer: A phase 2 clinical trial. Gynecol Oncol (2020) 159(1):72-78 https://pubmed.ncbi.nlm.nih.gov/32771276/