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Efficacy and Safety of Becotatug Vedotin (MRG003) Combined With Anti-PD1 as Maintenance Therapy for Recurrent and Metastatic Nasopharyngeal Carcinoma
Sponsor: Sun Yat-sen University
Summary
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.
Official title: Efficacy and Safety of Becotatug Vedotin (MRG003) Combined With Anti-PD1 as Maintenance Therapy for Recurrent and Metastatic Nasopharyngeal Carcinoma: A Randomized, Controlled, Multicenter Phase III Clinical Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2026-07-20
Completion Date
2029-07-20
Last Updated
2026-07-15
Healthy Volunteers
No
Conditions
Interventions
Anti-PD1
Anti-PD1 : Intravenous infusion on Day 1 of each 21-day cycle, administered for up to 2 years.
Anti-PD1 combined with Becotatug Vedotin
Anti-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.
Locations (1)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China