Recurrent or Metastatic NPCPhase 2NCT04562441
NPC - AXEL Study : Axitinib-Avelumab
A Phase 2 study testing Axitinib and Avelumab in people with Recurrent or Metastatic NPC, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Nasopharyngeal cancer (NPC) is the most common head and neck cancer in South China and South East Asia. Worldwide, there are 80,000 incident cases and 50,000 deaths annually. In Hong Kong, NPC ranked as the tenth most common cancer in man. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent or Metastatic NPC
- What is being tested?
- Axitinib and Avelumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 May 2021to 7 Nov 2024
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at initial diagnosis or at recurrence).
- Available fresh or archival tumor tissue for biomarker study
- Patients with recurrent or metastatic NPC that has progressed following one line of prior platinum-based chemotherapy.
- Disease must be not amenable to potentially curative radiotherapy or surgery.
- At least one measurable lesion as defined by RECIST v1.1 that has not been previously irradiated.
- Age 18 or above;
- ECOG performance 0 or 1.
- Adequate bone marrow, renal and hepatic reserve.
Who cannot join
- Prior therapy with immune check point inhibitors or VEGF pathway inhibitors.
- Presence of local recurrence.
- Presence of neck lymph node recurrence invading vascular structure.
- Presence of central lung lesions involving major blood vessels.
- History of hemoptysis or epistaxis within 4 weeks.
- Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite adequate medical therapy.
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- Gastrointestinal abnormalities, including inability to take oral medication or malabsorption syndrome.
- Concurrent use or anticipated need for treatment with known potent CYP3A4 inhibitors or CYP3A4 /CYP1A2 inducers.
- CNS metastases requiring systemic steroid
- Active autoimmune disease
- Pregnant or lactating female
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
About this study
Official title: AXEL: Axitinib-Avelumab Combination in Recurrent or Metastatic Nasopharyngeal Cancer: a Multicenter Phase 2 Trial
Nasopharyngeal cancer (NPC) is the most common head and neck cancer in South China and South East Asia. Worldwide, there are 80,000 incident cases and 50,000 deaths annually. In Hong Kong, NPC ranked as the tenth most common cancer in man. Up to 30% of NPC patients will develop recurrence or metastases after primary radiotherapy or chemoradiation. Platinum-based chemotherapy regimen has been the main stay of first line treatment for recurrent or metastatic NPC. However, the duration of response is short and currently there is no recommended standard second line chemotherapy. Axitinib is a highly potent and selective inhibitor of VEGF receptor. Selectively targeting a single growth factor receptor pathway provides the potential to rationally adjust dosages and combine drugs directed at specific parts of the pathway to minimize toxicity and achieve the optimum therapeutic benefit. In the phase 2 axitinib monotherapy in recurrent or metastatic NPC who failed at least one line of chemotherapy, the clinical benefit rate (CBR, complete response + partial response + stable disease) was 78.4% at 3 months but decreased to 43.2% at 6 months. However, the confirmed objective response rate (ORR) by RECIST was only 2.7% and unconfirmed ORR of 18.9%, with no complete response.Recently, the promising clinical activity of immune check point inhibitors has been demonstrated in NPC. The ORR was 25.9% (7 partial responses out of 27 patients) for single agent pembrolizumab, and 20.5% (including 1 complete response and 7 partial responses out of 44 patients) for single agent nivolumab,9 in recurrent or metastatic NPC who failed at least first line chemotherapy.
The combination of axitinib and avelumab has been studied in renal cell carcinoma (RCC). Based on the above promising and positive results in renal cell carcinoma (RCC) and head and neck squamous cell carcinomas (HNSCC), the investigators hypothesize that the combination of axitinib and avelumab in the second line setting of NPC will achieving a more complete, deep and durable response than either agent alone, without a significant increase in toxicity.
This is an open-label, single arm, phase 2 clinical trial evaluating the activity and safety of the combination of axitinib and avelumab in recurrent or metastatic NPC patients who failed at least one line of platinum-based chemotherapy.
- Conditions
- Recurrent or Metastatic NPC
- Being tested
- Axitinib, Avelumab
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxitinibDrug
Axitinib: 5 mg bd po Day 1 to Day 28
AvelumabDrug
Avelumab: 10 mg/kg Day 1 to Day 15 every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Axitinib and Avelumab | Experimental | Axitinib: 5 mg bd po Day 1 to Day 28
Avelumab: 10mg/kg Day 1 and Day 15 every 4 weeks Receives: Drug: Axitinib; Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed objective response rate (ORR)
Measured: 2 years
Secondary outcomes (11)
Progression-free survival (PFS)
Measured: 3 years
6-month PFS rate
Measured: 6 months
Overall survival (OS)
Measured: 3 years
OS rates at 12 months and 24 months
Measured: 2 years
Objective tumor response rate
Measured: 2 years
Disease control rate (DCR) at 12 and 24 weeks
Measured: 2 years
Time to tumor response (TTR)
Measured: 2 years
Duration of response (DR)
Measured: 2 years
Patient-Reported Outcomes (FACT-NP)
Measured: 2 years
Patient-Reported Outcomes (EQ-5D)
Measured: 2 years
Type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start6 May 2021
- Primary completion31 Oct 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic NPCStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edwin P Hui, Chinese University of Hong Kong
- Investigators
- Anthony Chan, MD, Principal investigator, Department of Clinical Oncology, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562441
- Sponsor's protocol ID
- NPC 033
- Status last verified
- Jan 2025
- First submitted
- 14 Sep 2020
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AXEL: Axitinib-Avelumab Combination in Recurrent or Metastatic Nasopharyngeal Cancer: a Multicenter Phase 2 Trial
- ClinicalTrials.gov ID
- NCT04562441
- Acronym / sponsor ID
- NPC 033
- Conditions
- Recurrent or Metastatic NPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 24 Sep 2020 (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.
Nasopharyngeal cancer (NPC) is the most common head and neck cancer in South China and South East Asia. Worldwide, there are 80,000 incident cases and 50,000 deaths annually. In Hong Kong, NPC ranked as the tenth most common cancer in man. Up to 30% of NPC patients will develop recurrence or metastases after primary radiotherapy or chemoradiation. Platinum-based chemotherapy regimen has been the main stay of first line treatment for recurrent or metastatic NPC. However, the duration of response is short and currently there is no recommended standard second line chemotherapy. Axitinib is a highly potent and selective inhibitor of VEGF receptor. Selectively targeting a single growth factor receptor pathway provides the potential to rationally adjust dosages and combine drugs directed at specific parts of the pathway to minimize toxicity and achieve the optimum therapeutic benefit. In the phase 2 axitinib monotherapy in recurrent or metastatic NPC who failed at least one line of chemotherapy, the clinical benefit rate (CBR, complete response + partial response + stable disease) was 78.4% at 3 months but decreased to 43.2% at 6 months. However, the confirmed objective response rate (ORR) by RECIST was only 2.7% and unconfirmed ORR of 18.9%, with no complete response.Recently, the promising clinical activity of immune check point inhibitors has been demonstrated in NPC. The ORR was 25.9% (7 partial responses out of 27 patients) for single agent pembrolizumab, and 20.5% (including 1 complete response and 7 partial responses out of 44 patients) for single agent nivolumab,9 in recurrent or metastatic NPC who failed at least first line chemotherapy.
The combination of axitinib and avelumab has been studied in renal cell carcinoma (RCC). Based on the above promising and positive results in renal cell carcinoma (RCC) and head and neck squamous cell carcinomas (HNSCC), the investigators hypothesize that the combination of axitinib and avelumab in the second line setting of NPC will achieving a more complete, deep and durable response than either agent alone, without a significant increase in toxicity.
This is an open-label, single arm, phase 2 clinical trial evaluating the activity and safety of the combination of axitinib and avelumab in recurrent or metastatic NPC patients who failed at least one line of platinum-based chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axitinib and Avelumab | Experimental | Drug: Axitinib, Drug: AvelumabAxitinib: 5 mg bd po Day 1 to Day 28 Avelumab: 10mg/kg Day 1 and Day 15 every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at initial diagnosis or at recurrence).
- Available fresh or archival tumor tissue for biomarker study
- Patients with recurrent or metastatic NPC that has progressed following one line of prior platinum-based chemotherapy.
- Disease must be not amenable to potentially curative radiotherapy or surgery.
- At least one measurable lesion as defined by RECIST v1.1 that has not been previously irradiated.
Key exclusion criteria (11 listed)
- Prior therapy with immune check point inhibitors or VEGF pathway inhibitors.
- Presence of local recurrence.
- Presence of neck lymph node recurrence invading vascular structure.
- Presence of central lung lesions involving major blood vessels.
- History of hemoptysis or epistaxis within 4 weeks.
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 |
|---|---|---|
| AxitinibAxitinib: 5 mg bd po Day 1 to Day 28 | Drug | Axitinib and Avelumab |
| AvelumabAvelumab: 10 mg/kg Day 1 to Day 15 every 4 weeks | Drug | Axitinib and Avelumab |
Primary outcome
Confirmed objective response rate (ORR)
Time frame: 2 years
11 secondary outcomes
Progression-free survival (PFS)
Time frame: 3 years
6-month PFS rate
Time frame: 6 months
Overall survival (OS)
Time frame: 3 years
OS rates at 12 months and 24 months
Time frame: 2 years
Objective tumor response rate
Time frame: 2 years
Disease control rate (DCR) at 12 and 24 weeks
Time frame: 2 years
Time to tumor response (TTR)
Time frame: 2 years
Duration of response (DR)
Time frame: 2 years
Patient-Reported Outcomes (FACT-NP)
Time frame: 2 years
Patient-Reported Outcomes (EQ-5D)
Time frame: 2 years
Type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0)
Time frame: 2 years
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 10 Jan 2025.
- Individual participant dataSharing planned: No
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Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
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A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma (TAISHAN-301)
Nasopharyngeal Carcinoma
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A Study of Anti-PD-1 Antibody With or Without BL-B01D1 as Maintenance Therapy Following Anti-PD-1 Antibody Plus Chemotherapy for the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (PANKU-NPC02)
Nasopharyngeal Carcinoma (NPC)
Not yet recruitingPhase 1/2
A Study of BL-M08D1 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma and Other Solid Tumors
Nasopharyngeal Carcinoma (NPC), Solid Tumors
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.
Anthony Chan, MD principal investigator
Department of Clinical Oncology, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Axitinib and Avelumab in people with Recurrent or Metastatic NPC, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 8 inclusion and 11 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 10 Jan 2025. 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 Hong Kong. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Confirmed objective response rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2025.