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Completed

NCT Number: NCT06676293

Compassionate Use of Asparaginase and Pembrolizumab Combination Theaapy for Nasopharyngeal Carcinoma

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.

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Key information

Conditions

Nasopharyngeal Carcinoma (NPC) Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan City, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Active autoimmune disease

-

Treatment and study plan

Anti-PD1

Drug

Pembrolizumab 100mg in normal saline 100ml infusion over 30 minutes for every two month

asparaginase

Drug

The patients will receive asparaginase 10000IU/vail IM QD for three or five days.

Primary outcomes

  1. Quantitative Analysis of Plasma EBV DNA Levels for Treatment Response

    Time frame: 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 outcomes

  1. FDG PET/CT scan

    Time frame: 3 month

    FDG PET/CT for detecting tumor existence

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Compassionate Use of Combination Therapy with Asparaginase and Pembrolizumab in Patients with Nasopharyngeal Carcinoma

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 6, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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