- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03866967
A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma
January 3, 2024 updated by: Akeso
A Single-arm, Open-label, Multicenter Phase II Clinical Study of AK105 in Patients With Metastatic Nasopharyngeal Carcinoma After Failure of Second and Subsequent Lines of Chemotherapy
This is a multicenter, single-arm open-label, phase II study to evaluate the anti-tumor activity, safety, PK and immunogenicity of AK105 (Anti-PD1 antibody) in patients with metastatic nasopharyngeal carcinoma who have progressed after at least 2 prior lines of systemic chemotherapy (of which one of them must be platinum-based chemotherapy).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100142
- Beijing Cancer Hospital
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Shanghai
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Shanghai, Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 nonkeratinizing differentiated or undifferentiated NPC.
- Not suitable for radical local therapy.
- Stage IVb metastatic NPC patients who have failed the first-line platinum-based chemotherapy and the second-line chemotherapy.
- At least one measurable tumor lesion per RECIST 1.1 criteria. A lesion previously treated with local therapies such as radiotherapy can be considered a target lesion if there is objective evidence of progression in the lesion.
- 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.
Exclusion Criteria:
- Receipt of last radiotherapy or any anti-tumor treatment [chemotherapy, targeted therapy, immunotherapy, Chinese herbal drugs with antitumor indications, or immunomodulators or tumor embolization] within 4 weeks prior to the first dose of study treatment. Nitrosourea or mitomycin C treatment within 6 weeks prior to the first dose of AK105.
- Prior exposure to any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (e.g. CD40, CD137, GITR and OX40 etc).
- 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.
- Subjects with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors.
- Active or previously documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis or chronic diarrhea).
- Subjects who require systemic corticosteroids (a dose equivalent to >10 mg/day prednisone) or other immunosuppressive drugs within 14 days prior to the first dose of study drug.
- Known history of testing positive for human immunodeficiency virus (HIV).
- Known history of primary immunodeficiency virus infection.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- History of gastrointestinal perforation and/ or fistula within 6 months prior to enrollment.
- Necrotic lesion(s) found by examinations within 4 weeks prior to enrollment, which, in the investigator's opinion, is at risk of massive bleeding.
- Known history of interstitial lung disease.
- Known history of active tuberculosis (TB).
- Serious infections within 4 weeks prior to the first dose of study drug, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia.
- An active infection requiring systemic therapy.
- Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ mL or active hepatitis C virus (HCV) should be excluded. Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA <500 IU/ mL) , and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.
- Major surgery (as defined by the investigator) within 30 days prior to the first dose of study drug.
- Presence of meningeal metastasis, spinal cord compression, leptomeningeal disease, or active brain metastasis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria, with the exception of alopecia.
- Receipt of live or attenuated vaccination within 30 days prior to the first dose of study treatment, or plan to receive live or attenuated vaccine during the study.
- Known history of server hypersensitivity to other monoclonal antibodies.
- Known severe allergic reactions to paclitaxel, carboplatin, or their preventive medications.
- Known allergic reactions to any ingredients of AK105.
- Pregnant or lactating women.
- Any conditions that, in the investigator's opinion, may put subjects treated with the study drug at risks, or interfere with the evaluation of study drug or subject safety, or the interpretation of study results.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AK105
Subjects receive AK105 200 mg intravenously (IV) once every 2 weeks (Q2W) until progression.
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intravenous (IV) infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR) assessed by IRRC per RECIST v1.1 for anti-tumor activity in the Full Analysis Set (FAS) population
Time Frame: up to 2 years
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ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
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up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observed concentrations of AK105
Time Frame: From first dose of AK105 through 90 days after last dose of AK105
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The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.
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From first dose of AK105 through 90 days after last dose of AK105
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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
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The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
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From first dose of AK105 through 90 days after last dose of AK105
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Incidence and severity of treatment-emergent adverse events (TEAEs)
Time Frame: From the time of informed consent signed through 90 days after last dose of AK105
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An adverse event (AE) is any untoward medical occurrence or the deterioration of existing medical event in a clinical study subject administered an investigational drug, which does not necessarily have an unequivocal causal relationship with the investigational product.
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From the time of informed consent signed through 90 days after last dose of AK105
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Progression-free survival (PFS) as assessed by IRRC and investigator
Time Frame: up to 2 years
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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).
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up to 2 years
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Disease control rate (DCR) as assessed by IRRC and investigator
Time Frame: up to 2 years
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DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.
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up to 2 years
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Duration of response (DoR) as assessed by IRRC and investigator
Time Frame: up to 2 years
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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.
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up to 2 years
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Overall survival (OS)
Time Frame: up to 2 years
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OS is defined as the time from the date of randomization to death from any cause.
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up to 2 years
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ORR as assessed by investigator per RECIST v1.1 for anti-tumor activity in the FAS population
Time Frame: up to 2 years
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ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
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up to 2 years
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Time to response (TTR) assessed by IRRC and investigator ;
Time Frame: up to 2 years
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TTR is defined as the time from the first dose of study drug to the first documented response (CR or PR).
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up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Chaosu Hu, MD, Fudan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 27, 2019
Primary Completion (Actual)
March 13, 2021
Study Completion (Estimated)
April 13, 2024
Study Registration Dates
First Submitted
March 6, 2019
First Submitted That Met QC Criteria
March 6, 2019
First Posted (Actual)
March 7, 2019
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 3, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- AK105-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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