Efficacy and Safety of Becotatug Vedotin (MRG003) Combined With Anti-PD1 as Maintenance Therapy for Recurrent and Metastatic Nasopharyngeal Carcinoma

NCT07705243 | Recruiting Phase 3 DMC

• 1 other identifier: SYSKY-2026-289-02
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Cancinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• 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

  From randomization to 10 months

Secondary Outcomes (6)

• overall survival

  From randomization to 3 years

• Second-line progression-free survival

  From enrollment to 20 months

• Duration of response

  From enrollment to the end of treatment at 3 weeks

• Objective response rate

  From enrollment to the end of treatment at 3 weeks

• Disease control rate

  From enrollment to the end of treatment at 3 weeks

Study Arms (2)

Anti-PD1 maintenance group

ACTIVE COMPARATOR

days 1, 21 days/cycle, administered for up to 2 years

Drug: Anti-PD1

Anti-PD1 plus Becotatug Vedotin maintenance group

EXPERIMENTAL

Anti-PD1, 21 days/cycle, administered for up to 2 years; Becotatug Vedotindays 1.5 mg/kg, 21 days/cycle, administered for up to 2 years.

Drug: Anti-PD1 combined with Becotatug Vedotin

Interventions

Anti-PD1 DRUG

Anti-PD1 : Intravenous infusion on Day 1 of each 21-day cycle, administered for up to 2 years.

Anti-PD1 maintenance group

Anti-PD1 combined with Becotatug Vedotin DRUG

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.

Anti-PD1 plus Becotatug Vedotin maintenance group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
• Expected survival of at least 12 weeks;
• No prior systemic chemotherapy administered within 6 months before diagnosis (excluding patients with disease progression more than 6 months after neoadjuvant chemotherapy, adjuvant chemotherapy, or definitive concurrent chemoradiotherapy);
• At least one measurable lesion as defined by RECIST v1.1;
• Adequate organ and bone marrow function as defined below:
• HGB ≥90 g/L, WBC ≥4×10⁹/L, PLT ≥100×10⁹/L.
• Liver function: TBIL \<1.5 × ULN; ALT and/or AST \<2.5 × ULN. For patients with liver metastases, ALT or AST \<5 × ULN. For patients with liver or bone metastases, ALP \<5 × ULN.
• Renal function: creatinine \<1.5 × ULN.
• Coagulation: INR of PT / PTT \<1.5 × ULN;
• Able to provide written informed consent and comply with all protocol-specified procedures including laboratory tests and follow-up visits;
• Female subjects of childbearing potential and male subjects with childbearing potential partners must agree to use effective contraception from screening through 6 months after the last dose of study treatment (e.g., condoms, regular oral contraceptives as prescribed).

You may not qualify if:

• 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;
• Patients with positive HIV antibody;
• Active bacterial, fungal, viral infection requiring systemic treatment, or interstitial pneumonia within 1 week prior to the first administration of study drugs;
• Received anti-tumor therapies including chemotherapy, small-molecule inhibitors, immunotherapy (e.g., interleukins, interferons, thymosins) within 4 weeks or 5 half-lives (whichever is shorter, with a minimum interval of 2 weeks) before the first dose of study drugs;
• Received anti-tumor therapies including chemotherapy, small-molecule inhibitors, immunotherapy (e.g., interleukins, interferons, thymosins) within 4 weeks or 5 half-lives (whichever is shorter, with a minimum interval of 2 weeks) before the first dose of study drugs;
• Underwent major surgery within 3 months prior to the first dose, or planned to receive major surgery during the study period;
• Severe thromboembolic events within 6 months before screening, such as cerebrovascular accidents (including transient ischemic attack) and pulmonary embolism;
• Active malignant tumors within 2 years prior to the first administration of study drugs, excluding nasopharyngeal carcinoma under investigation and any locally curable tumors that have received radical treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ);
• Severe cardiovascular diseases within 6 months before enrollment, including but not limited to:
• Acute myocardial infarction, unstable angina, coronary angioplasty or stenting, deep vein thrombosis, stroke;
• New York Heart Association (NYHA) Class III or IV congestive heart failure, or left ventricular ejection fraction (LVEF) \< 50%;
• Electrocardiogram (ECG) abnormalities of significant clinical relevance at screening as assessed by the investigator;

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

spartalizumab

Central Study Contacts

Liu Guoying

CONTACT

18127919832; liugy0109@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 15, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 20, 2028
• Study Completion (Estimated): July 20, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)