A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma
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|ClinicalTrials.gov Identifier: NCT03866967|
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Biological: AK105||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||153 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Open-label, Multicenter, Phase II Study of AK105 in Patients With Metastatic Nasopharyngeal Carcinoma Who Have Progressed After At Least 2 Prior Lines of Chemotherapy|
|Estimated Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||June 15, 2020|
|Estimated Study Completion Date :||December 15, 2020|
Subjects receive AK105 200 mg intravenously (IV) once every 2 weeks (Q2W) until progression.
intravenous (IV) infusion
- Objective response rate (ORR) in the full analysis set (FAS) population [ Time Frame: up to 2 years ]ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
- ORR in the PD-L1 positive population [ Time Frame: up to 2 years ]ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
- Progression-free survival (PFS) [ Time Frame: up to 2 years ]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).
- Disease control rate (DCR) [ Time Frame: up to 2 years ]DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.
- Duration of response (DoR) [ Time Frame: up to 2 years ]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.
- Overall survival (OS) [ Time Frame: up to 2 years ]OS is defined as the time from the date of randomization to death from any cause.
- 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 ]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.
- Observed concentrations of AK105 [ Time Frame: From first dose of AK105 through 90 days after last dose of AK105 ]The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.
- 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 ]The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866967
|Contact: Xiaoping Jinfirstname.lastname@example.org|
|Beijing Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100142|
|Principal Investigator: Yan Sun, MD|
|FuDan University Shanghai Cancer Center||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: , MD|
|Principal Investigator: Chaosu Hu, MD|
|Principal Investigator:||Chaosu Hu, MD||Fudan University|