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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.
Enrollment
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Inclusion criteria
Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of gestational trophoblastic neoplasia (hydatidiform-mole, invasive mole, gestational choriocarcinoma, placental site trophoblastic tumor, and epithelioid trophoblastic tumor) refractory or chemo-resistant to multi-agent chemotherapy (such as EMA-CO, EMA-EP, BEP, TP-TE etc.) status will be enrolled in this study.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential
The participant provides written informed consent for the trial.
Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded tissue blocks are preferred to slides. It might be enrolled in this study even if tissue is not available for a variety of reasons.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation.
Have adequate organ function as defined in the followings;
Exclusion criteria
Primary purpose
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15 participants in 1 patient group
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Central trial contact
Min Chul Choi, MD
Data sourced from clinicaltrials.gov
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