Compassionate Use of Asparaginase and Pembrolizumab Combination Theaapy for Nasopharyngeal Carcinoma

NCT06676293 | Completed

• 1 other identifier: IRB NO. 202400085B0
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

NPC; ICB; asparaginase

Outcome Measures

Primary Outcomes (1)

• Quantitative Analysis of Plasma EBV DNA Levels for Treatment Response

  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.

  Until the end of the study

Secondary Outcomes (1)

• FDG PET/CT scan

  3 month

Study Arms (2)

combination therapy

EXPERIMENTAL

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.

Drug: Anti-PD1; Drug: asparaginase

anti-PD1 alone

PLACEBO COMPARATOR

The patients will receive pembrolizumab treatment.

Drug: Anti-PD1

Interventions

Anti-PD1 DRUG

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

anti-PD1 alone; combination therapy

asparaginase DRUG

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

combination therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

Related Publications (1)

• Gnanaprakasam JNR, Kushwaha B, Liu L, Chen X, Kang S, Wang T, Cassel TA, Adams CM, Higashi RM, Scott DA, Xin G, Li Z, Yang J, Lane AN, Fan TW, Zhang J, Wang R. Asparagine restriction enhances CD8+ T cell metabolic fitness and antitumoral functionality through an NRF2-dependent stress response. Nat Metab. 2023 Aug;5(8):1423-1439. doi: 10.1038/s42255-023-00856-1. Epub 2023 Aug 7.

  PMID: 37550596 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

spartalizumab; Asparaginase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Huang-Yu Yang, M.D./Ph.D

  Chang Gung Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: August 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: August 1, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-10

Locations

TW (1)