Nasopharyngeal CarcinomaPhase 2NCT04736810
A Study of Penpulimab Combination Therapy in Patients With Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing AK105, Cisplatin and Gemcitabine in people with Nasopharyngeal Carcinoma, run by Akeso at 1 site in China.
Trial summary
This is a multi-center, randomized, open-label, phase II study to evaluate the efficacy and safety of anti-PD-1 antibody Penpulimab (AK105) combined with chemotherapy ± anlotinib hydrochloride in the first-line treatment of patients with advanced nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- AK105, Cisplatin and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2021to 18 Dec 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent form voluntarily.
- Age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Expected life expectance ≥ 3 months.
- Histologically confirmed diagnosis of stage IVb NPC (AJCC 8th).
- Metastatic NPC patients who have not recieved the first-line platinumbased chemotherapy.
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- At least one measurable tumor lesion per RECIST 1.1 criteria.
- Subjects must provide an available tumor tissue sample taken within 3 years prior to enrollment.
- Adequate organ function.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception.
- Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.
Who cannot join
- Other invasive malignancies within 2 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
- Is currently participating in a study of an investigational agent or using an investigational device.
- Has known active central nervous system (CNS) metastases.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study.
- Has an active infection requiring systemic therapy.
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
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- History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment.
- Has undergone major surgery within 30 days of Study Day 1.
- Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital of the University of Chinese Academy of Sciences
Hangzhou, Zhejiang, 310022
About this study
Official title: A Phase II Study of Penpulimab Combined With Chemotherapy ± Anlotinib Hydrochloride in Patients With Advanced Nasopharyngeal Carcinoma
This is a multi-center, randomized, open-label, phase II study to evaluate the efficacy and safety of anti-PD-1 antibody Penpulimab (AK105) combined with chemotherapy ± anlotinib hydrochloride in the first-line treatment of patients with advanced nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- AK105, Cisplatin, Gemcitabine, Anlotinib hydrochloride
- Keywords
- Immunotherapy, Anti-PD-1 antibody, Nasopharyngeal Carcinoma, VEGF
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK105Biological
IV infusion
CisplatinDrug
IV infusion
GemcitabineDrug
IV infusion
Anlotinib hydrochlorideDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| AK105 plus Gemcitabine and Anlotinib Hydrochloride | Experimental | Not described Receives: Biological: AK105; Drug: Cisplatin; Drug: Gemcitabine; Drug: Anlotinib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is the proportion of subjects with CR or PR based on RECIST v1.1.
Measured: up to 2 years
Secondary outcomes (6)
Progression-free survival (PFS)
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) or death from any cause (whichever occurs first).
Measured: up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.
Measured: up to 2 years
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: up to 2 years
Overall survival (OS)
OS is defined as the time from the date of randomization to death from any cause.
Measured: up to 2 years
Observed concentrations of AK105
The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.
Measured: From first dose of AK105 through 90 days after last dose of AK105.
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
Measured: From first dose of AK105 through 90 days after last dose of AK105.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start25 Feb 2021
- Primary completion9 Jun 2022
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by AkesoThe 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Akeso Tiancheng, Inc
- Responsible party
- Sponsor
- Investigators
- Xiaozhong Chen, MD, Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736810
- Sponsor's protocol ID
- AK105-205
- Status last verified
- Mar 2025
- First submitted
- 30 Jan 2021
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Penpulimab Combined With Chemotherapy ± Anlotinib Hydrochloride in Patients With Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04736810
- Acronym / sponsor ID
- AK105-205
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Immunotherapy, Anti-PD-1 antibody, Nasopharyngeal Carcinoma, VEGF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Collaborators
- Akeso Tiancheng, Inc
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 3 Feb 2021 (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.
This is a multi-center, randomized, open-label, phase II study to evaluate the efficacy and safety of anti-PD-1 antibody Penpulimab (AK105) combined with chemotherapy ± anlotinib hydrochloride in the first-line treatment of patients with advanced nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK105 plus Gemcitabine and Anlotinib Hydrochloride | Experimental | Biological: AK105, Drug: Cisplatin, Drug: Gemcitabine, Drug: Anlotinib hydrochloride |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent form voluntarily.
- Age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Expected life expectance ≥ 3 months.
- Histologically confirmed diagnosis of stage IVb NPC (AJCC 8th).
Key exclusion criteria (12 listed)
- Other invasive malignancies within 2 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
- Is currently participating in a study of an investigational agent or using an investigational device.
- Has known active central nervous system (CNS) metastases.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study.
- Has an active infection requiring systemic therapy.
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 |
|---|---|---|
| AK105IV infusion | Biological | AK105 plus Gemcitabine and Anlotinib Hydrochloride |
| CisplatinIV infusion | Drug | AK105 plus Gemcitabine and Anlotinib Hydrochloride |
| GemcitabineIV infusion | Drug | AK105 plus Gemcitabine and Anlotinib Hydrochloride |
| Anlotinib hydrochlorideOral administration | Drug | AK105 plus Gemcitabine and Anlotinib Hydrochloride |
Primary outcome
Objective response rate (ORR)
Time frame: up to 2 years
ORR is the proportion of subjects with CR or PR based on RECIST v1.1.
6 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 2 years
Disease control rate (DCR)
Time frame: up to 2 years
Duration of response (DoR)
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 2 years
Observed concentrations of AK105
Time frame: From first dose of AK105 through 90 days after last dose of AK105.
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of AK105 through 90 days after last dose of AK105.
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 Mar 2025.
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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.
Xiaozhong Chen, MD study chair
Zhejiang Cancer Hospital
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 AK105, Cisplatin and Gemcitabine in people with Nasopharyngeal Carcinoma, run by Akeso at 1 site in China.
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 11 inclusion and 12 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 Mar 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 China. 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?
Objective response rate (ORR) (time frame: up to 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 7 Mar 2025.