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Compassionate Use of Asparaginase and Pembrolizumab Combination Theaapy for Nasopharyngeal Carcinoma

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Nasopharyngeal Carcinoma (NPC)

Treatments

Drug: asparaginase
Drug: Anti-PD1

Study type

Interventional

Funder types

Other

Identifiers

NCT06676293
IRB NO. 202400085B0

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria: Active autoimmune disease

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

8 participants in 2 patient groups, including a placebo group

combination therapy
Experimental group
Description:
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.
Treatment:
Drug: Anti-PD1
Drug: asparaginase
anti-PD1 alone
Placebo Comparator group
Description:
The patients will receive pembrolizumab treatment.
Treatment:
Drug: Anti-PD1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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