Nasopharyngeal Carcinoma (NPC)NCT06676293
Compassionate Use of Asparaginase and Pembrolizumab Combination Theaapy for Nasopharyngeal Carcinoma
A study testing Anti-PD1 and asparaginase in people with Nasopharyngeal Carcinoma (NPC), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Anti-PD1 and asparaginase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compassionate Use of Combination Therapy with Asparaginase and Pembrolizumab in Patients with 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.
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Anti-PD1, asparaginase
- Keywords
- NPC, ICB, asparaginase
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD1Drug
Pembrolizumab 100mg in normal saline 100ml infusion over 30 minutes for every two month
asparaginaseDrug
The patients will receive asparaginase 10000IU/vail IM QD for three or five days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Anti-PD1; Drug: asparaginase |
| anti-PD1 alone | Placebo comparator | The patients will receive pembrolizumab treatment. Receives: Drug: Anti-PD1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until the end of the study
Secondary outcomes (1)
FDG PET/CT scan
FDG PET/CT for detecting tumor existence
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Aug 2023
- Primary completion30 Apr 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang-Yu Yang, M.D./Ph.D, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676293
- Sponsor's protocol ID
- IRB NO. 202400085B0
- Status last verified
- Oct 2024
- First submitted
- 4 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37550596
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Combination Therapy with Asparaginase and Pembrolizumab in Patients with Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT06676293
- Acronym / sponsor ID
- IRB NO. 202400085B0
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- NPC, ICB, asparaginase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination therapy | Experimental | Drug: Anti-PD1, Drug: asparaginaseThe 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 | Placebo comparator | Drug: Anti-PD1The patients will receive pembrolizumab treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-PD1Pembrolizumab 100mg in normal saline 100ml infusion over 30 minutes for every two month | Drug | anti-PD1 alone, combination therapy |
| asparaginaseThe patients will receive asparaginase 10000IU/vail IM QD for three or five days. | Drug | combination therapy |
Primary outcome
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.
1 secondary outcome
FDG PET/CT scan
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Background: PubMed 37550596Gnanaprakasam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang-Yu Yang, M.D./Ph.D study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-PD1 and asparaginase in people with Nasopharyngeal Carcinoma (NPC), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Analysis of Plasma EBV DNA Levels for Treatment Response (time frame: Until the end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06676293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.