Compassionate Use of Asparaginase and Pembrolizumab Combination Theaapy for Nasopharyngeal Carcinoma

Not Applicable

Completed

• Conditions: Nasopharyngeal Carcinoma (NPC)
• Interventions: Drug: Anti-PD1; Drug: asparaginase

• Registration Number: NCT06676293
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The goal of this study is to investigate the outcomes of patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC) or recurrent-metastatic nasopharyngeal carcinoma (RM-NPC) treated with a combination of immune checkpoint blockade (ICB) and asparaginase.

Detailed Description

This study is being conducted to investigate the synergistic effect of combining asparaginase with immune checkpoint blockade (ICB) in tumor-bearing mice. Findings indicate that asparaginase enhances CD8+ T cell activation, and previous reports have shown that nasopharyngeal carcinoma (NPC) patients exhibit a lower response rate to ICB treatment. This study aims to determine whether the combination therapy of asparaginase and ICB is more effective or less effective compared to the standard ICB-only approach for patients with locoregionally advanced (LA-NPC) or recurrent-metastatic NPC (RM-NPC). Participants are being enrolled who have previously received ICB but continue to experience disease progression.

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-08-01
• Status Verified: 2024-10
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Study First Posted: 2024-11-06
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Patients who have previously received immune checkpoint blockade therapy but are still experiencing disease progression -

Exclusion Criteria

Active autoimmune disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combination therapy	Anti-PD1	The patients will receive asparaginase 10000IU/vail IM QD for three or five days, followed by pembrolizumab treatment. and Pembrolizumab 100mg in normal saline 100ml infusion over 30 minutes.
combination therapy	asparaginase	The patients will receive asparaginase 10000IU/vail IM QD for three or five days, followed by pembrolizumab treatment. and Pembrolizumab 100mg in normal saline 100ml infusion over 30 minutes.
anti-PD1 alone	Anti-PD1	The patients will receive pembrolizumab treatment.

Primary Outcome Measures

Name	Time	Method
Quantitative Analysis of Plasma EBV DNA Levels for Treatment Response	Until the end of the study	In nasopharyngeal carcinoma (NPC), plasma Epstein-Barr virus (EBV) DNA serves as a crucial biomarker for both diagnosis and monitoring. EBV, a herpesvirus that infects epithelial cells, is strongly associated with NPC development, especially in endemic regions. The transformation from latent EBV infection to active viral replication is considered a critical step in NPC pathogenesis. This transformation can be detected through circulating viral DNA levels in plasma or by measuring antibodies against various EBV antigens, such as EBNA1, VCA, and EA-D. Elevated EBV DNA levels often correlate with tumor burden and may serve as a predictor of NPC recurrence or progression. Consequently, plasma EBV DNA testing has become an essential tool in NPC clinical management, helping to guide treatment decisions and evaluate treatment response.

Secondary Outcome Measures

Name	Time	Method
FDG PET/CT scan	3 month	FDG PET/CT for detecting tumor existence

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan City, Taiwan