A Phase II Study of Pembrolizumab With Cisplatin and Gemcitabine Treatment in Patients With Recurrent Platinum-resistant Ovarian Cancer

Trial ID # NCT02608684
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 Cisplatin, Pembrolizumab, Gemcitabine
Eligible Participant

Platinum resistant or refractory ovarian cancer

Patients Enrolled

21; 20 HGS, 1 clear cell, median 2 prior therapies (1-5), 47.6% prior bevacizumab

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DCR, DoR, PFS, evaluated per RECIST


ORR: 61.1% (1CR, 10PR, n=18)
DCR: 88.9% (1CR, 10PR, 5SD, n=18)
DoR: 4.9 months
PFS: 6.2 months
Four patients received palliative radiation treatment. After receiving palliative radiation during pembrolizumab maintenance, one patient with recurrent clear cell ovarian cancer had reversal and normalization of CA125 trend, RECIST response improved from SD to PR, and response appears to be durable (completed 2 years of therapy and remains without disease 11 months after).

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: fatigue 14.2%


Adding pembrolizumab to cisplatin+gemcitabine and continuing as maintenance treatment results in promising response rates, however the median duration of response is modest and the addition of pembrolizumab does not appear to provide benefit beyond the use of chemotherapy alone in most patients


Walsh CS et al. Phase II trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer. PLoSOne (2021) 16(6):e0252665

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