This multicenter randomized controlled Phase III trial assesses the efficacy and safety of becotatug vedotin plus anti-PD-1 antibody as maintenance therapy for recurrent/metastatic nasopharyngeal carcinoma. Eligible patients aged 18-75 must have stable disease or positive plasma EBV DNA after 4-6 cycles of first-line chemoimmunotherapy, with adequate organ function and good physical status. A total of 86 subjects will be randomly split 1:1: the control group receives single anti-PD-1 maintenance, while the experimental group gets anti-PD-1 combined with becotatug vedotin in 21-day cycles for up to 2 years. Regular blood tests and tumor scans will be performed to monitor efficacy and adverse events graded by CTCAE v5.0; biological samples will be collected for biomarker research with consent. The primary endpoint is IRC-reviewed progression-free survival, with secondary endpoints covering overall survival, tumor response rates and safety. Overseen by an independent ethics committee, the trial ensures full data confidentiality. Participants sign informed consent and can withdraw anytime without interference to their routine cancer care, exploring a superior maintenance regimen for this high-risk NPC group.
Aged between 18 and 75 years at diagnosis, regardless of gender;
Histologically confirmed nasopharyngeal carcinoma;
Patients with advanced nasopharyngeal carcinoma with confirmed distant metastasis (Stage IVb per AJCC 8th edition; Stage IV per AJCC 9th edition), or recurrent nasopharyngeal carcinoma unsuitable for locoregional or curative therapy;
Achieved stable disease (SD) assessed per RECIST v1.1 or maintained positive plasma EBV DNA after 4 to 6 cycles of first-line chemotherapy combined with immunotherapy;
Peripheral neuropathy ≥ Grade 2 (per NCI-CTCAE v5.0);
History of hypersensitivity to any study drug;
Expected survival less than 3 months;
Active hepatitis B (positive HBsAg or HBcAb with HBV DNA ≥ 2000 IU/mL) or active hepatitis C (positive HCV antibody with HCV RNA above the lower limit of quantification at the study site). For patients with normal liver function receiving antiviral therapy, eligibility shall be determined by the investigator;
Parallel
Anti-PD1
DrugAnti-PD1 : Intravenous infusion on Day 1 of each 21-day cycle, administered for up to 2 years.
Anti-PD1 combined with Becotatug Vedotin
DrugAnti-PD1 : Intravenous infusion on Day 1 of each 21-day cycle, administered for up to 2 years; Becotatug Vedotin: Administered via intravenous infusion on Day 1 of each 21-day cycle, for up to 2 years.
Progression free survival
Progression free survival is defined as the time interval between randomization and the first recording of tumor progression (evaluated according to RECIST 1.1 criteria, regardless of continued treatment) or death from any cause
overall survival
Defined as the time from the date of randomization to the date of death from any cause.
Second-line progression-free survival
Defined as the time from randomization until the patient develops second disease progression or dies from any cause.
Duration of response
Defined as the time interval from the first documented objective tumor response to the first recorded disease progression or death from any cause.
Objective response rate
Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), ORR refers to the proportion of subjects achieving complete response (CR) plus partial response (PR)
Click on the lead sponsor to view all of their trials.
Sun Yat-sen University
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
