Gestational Trophoblastic Neoplasia
Conditions
Keywords
Gestational Trophoblastic Neoplasia, pembrolizumab, PD L1
Brief 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.
Interventions
Pembrolizumab administration at a fix dose of 200 mg every 3 weeks
Sponsors
Merck Sharp & Dohme LLC
CHA University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Chemo-Resistant Gestational Trophoblastic neoplasias
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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; 1. Patients with adequate bone marrow function measured within 28 days prior to administration of study treatment as defined below : Absolute granulocyte count ≥ 1.5 x 10 9 /L ; Platelet count ≥ 100 x 10 9 /L ; Haemoglobin ≥ 9.0 g/dL (may have been blood transfused) 2. Patients with adequate renal function : Calculated creatinine clearance ≥ 30 ml/min according to the Cockcroft-Gault formula (or local institutional standard method) 3. Patients with adequate hepatic function : Serum bilirubin ≤ 1.5 x UNL and AST/ALT ≤ 2.5 X UNL (≤ 5 X UNL for patients with liver metastases)
Exclusion criteria
* GTN is a pregnancy-related tumor, all candidates will be positive for pregnancy test. Therefore, a positive pregnancy test is not
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiological response assessed by the overall response according to iRECIST criteria assessed by imaging (CT scan and/or MRI if contraindicated). | 12 months |
| Serologic response assessed by serum b-hCG | 12 months |
Countries
South Korea
Contacts
Primary ContactMin Chul Choi, MD
Outcome results
None listed