Compassionate Use of Asparaginase and Pembrolizumab Combination Theaapy for Nasopharyngeal Carcinoma

NCT ID: NCT06676293

Last Updated: 2024-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-08-01

Brief Summary

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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

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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.

Conditions

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Nasopharyngeal Carcinoma (NPC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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combination therapy

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.

Group Type EXPERIMENTAL

Anti-PD1

Intervention Type DRUG

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

asparaginase

Intervention Type DRUG

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

anti-PD1 alone

The patients will receive pembrolizumab treatment.

Group Type PLACEBO_COMPARATOR

Anti-PD1

Intervention Type DRUG

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

Interventions

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Anti-PD1

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

Intervention Type DRUG

asparaginase

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

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huang-Yu Yang, M.D./Ph.D

Role: STUDY_CHAIR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 37550596 (View on PubMed)

Other Identifiers

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IRB NO. 202400085B0

Identifier Type: -

Identifier Source: org_study_id

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