Phase 2 Trial for Chemo-Resistant Gestational Trophoblastic Neoplasias With Pembrolizumab (CR-GTP)
Status:
Not yet recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
Gestational trophoblastic neoplasia (GTN) represents a group of rare tumors that accounts for
less than 5% of gynecologic cancers which arising from malignant transformation of
trophoblast, a cell originating from placenta. Placental expression of paternal antigens make
placenta a target for maternal immune recognition during pregnancy, and PD-L1 expression
maintains gestational tolerance. Also in GTN, PD-L1 is strongly expressed, suggesting the
ligand is involved in tumor-immune evasion.
Most female patients with GTN cured with chemotherapy, however less than 5.0% of them die as
a result of multi-drug resistance, necessitating novel approaches. Although there was limited
data due to its rarity, the treatment response of avelumab and pembrolizumab in GTN is
excellent (50% ~ 71.4% complete remission rate), as reported in the previous studies.
Therefore targeting of interaction PD-1/PD-L1 inhibition could be effective therapeutic
strategy in chemoresistant GTN.
This study investigate clinical efficacy of patients with GTN resistant/refractory to
multi-agent chemotherapy who treat with pembrolizumab.