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 MK3475, SCH 900475, Lambrolizumab, Keytruda
Drugs in Trial Cisplatin, Gemcitabine, Pembrolizumab
Eligible Participant

Platinum-resistant or refractory ovarian cancer

Patients Enrolled

19

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, DoR, PFS, evaluated per RECIST

Efficacy

ORR: 57% (1CR, 7PR, n=14)
DCR: 86% (1CR, 7PR, 4SD, n=14)
DoR: 3.5 months (0.6-6.6)
PFS: 5.4 months (1.2-17.3)
Four patients received palliative radiation treatment. 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 (currently on cycle 24 of treatment).

Conclusion

Adding pembrolizumab to cisplatin+gemcitabine and continuing as single-agent maintenance treatment results in promising response rates

Reference

Walsh C et al. Phase II trial of pembrolizumab with cisplatin and gemcitabine in women with recurrent platinum-resistant ovarian cancer. SGO (2019) Abstract 32
https://www.cancertherapyadvisor.com/home/news/conference-coverage/society-of-gynecologic-oncology-sgo/sgo-2019/pembro-chemo-recurrent-ovarian-cancer-risk-treatment/