NCT04303884

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: CHA University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gestational Trophoblastic Neoplasia

Interventions

Type	Name	Description
DRUG	Pembrolizumab Injection [Keytruda]	Pembrolizumab administration at a fix dose of 200 mg every 3 weeks

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-05-01
• Completion: 2023-05-01
• First posted: 2020-03-11
• Last updated: 2020-03-11

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study