An Open Label Phase II Trial of Guadecitabine and Pembrolizumab in Platinum Resistant Recurrent Ovarian Cancer

Trial ID # NCT02901899
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 Guadecitabine, Pembrolizumab
Eligible Participant

Platinum resistant ovarian cancer

Patients Enrolled

43, median 4 prior therapies (1-8)

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, PFS

Efficacy

ORR: 9.1% (3PR, n=33)
DCR: 54.5% (3PR, 15SD, n=33)
PFS: 2.8 months

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: neutropenia (40%), leukopenia (35%), lymphocytopenia (21%), hyponatremia (12%)

Conclusion

Pembrolizumab+guadecitabine has modest activity but some patients experience prolonged disease stabilization

Reference

Matei D et al. Phase II trial of guadecitabine priming and pembrolizumab in platinum resistant recurrent ovarian cancer. J Clin Oncol (2020) 38: (suppl; abstr 6025)

https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.6025

Matei D et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2020/07/Guadecitabine-and-Pembro-ASCO-2020.pdf

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