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Phase 2 Trial for Chemo-Resistant Gestational Trophoblastic Neoplasias With Pembrolizumab (CR-GTP) — CR-GTP  

Gestational Trophoblastic Neoplasia Clinical Trial

Official title:
Phase 2 Trial for Chemo-Resistant Gestational Trophoblastic Neoplasias With Pembrolizumab

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Gestational Trophoblastic Disease
  • Gestational Trophoblastic Neoplasia
  • Neoplasms
Clinical Trial Details
NCT number NCT04303884
Study type Interventional
Source CHA University
Contact Min Chul Choi, MD
Phone +82-31-780-6191
Email oursk79@cha.ac.kr
Status Not yet recruiting
Phase Phase 2
Start date June 1, 2020
Completion date May 1, 2023
View Details
See also
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Not yet recruiting NCT06020755 - Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 7 Phase 2
Recruiting NCT06028672 - Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 5-6 N/A
Terminated NCT02664961 - Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN) Phase 2
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Recruiting NCT05139095 - Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia Phase 2
Recruiting NCT05635344 - A Feasibility Window Study of Pembrolizumab Prior to Second Evacuation for Post-molar Gestational Trophoblastic Neoplasia Phase 2
Recruiting NCT04756713 - Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia Phase 3
Recruiting NCT03785574 - Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule N/A
Active, not recruiting NCT01823315 - Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia Phase 3
Not yet recruiting NCT06169644 - The Psychological Impact of GTN on Women Who Have Completed Chemotherapy Treatment
Recruiting NCT04812002 - Study of PD-1 Antibody and Bevacizumab in the Treatment of High-risk GTN After Combined Chemotherapy Phase 2