Nasopharyngeal Cancinoma (NPC)Phase 3NCT07705243
Efficacy and Safety of Becotatug Vedotin (MRG003) Combined With Anti-PD1 as Maintenance Therapy for Recurrent and Metastatic Nasopharyngeal Carcinoma
A Phase 3 study testing Anti-PD1 and Anti-PD1 combined with Becotatug Vedotin in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Anti-PD1 and Anti-PD1 combined with Becotatug Vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to 20 Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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;
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- 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;
- Pregnant or breastfeeding women;
- Presence of any severe and/or uncontrolled diseases that, in the investigator's judgment, may interfere with the patient's participation in the study (including but not limited to uncontrolled diabetes, dialysis-dependent renal disease, severe liver disease, life-threatening autoimmune and hemorrhagic diseases, substance abuse, neurological disorders);
- Any other conditions deemed inappropriate for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Liu Guoying, 18127919832, liugy0109@163.com
About this study
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
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.
Read the detailed description
The therapeutic outcomes of patients with recurrent and metastatic nasopharyngeal carcinoma (R/M NPC) remain unsatisfactory for high-risk subgroups after standard first-line chemoimmunotherapy. Numerous previous studies have shown that anti-PD-1 immune checkpoint inhibitors (ICIs) deliver prominent anti-tumor activity in frontline treatment for R/M NPC. Large-scale Phase III trials including CAPTAIN-1st, JUPITER-02 and RATIONALE-309 confirmed that chemotherapy combined with PD-1 monoclonal antibodies greatly prolonged patients' progression-free survival (PFS) and became the standard first-line regimen. However, a large proportion of patients only reach stable disease (SD) or retain positive plasma EBV DNA after 4-6 cycles of chemoimmunotherapy, and single PD-1 maintenance barely offers durable tumor control for this population, with median PFS shorter than 5 months.
In addition, antibody-drug conjugates (ADCs) represented by becotatug vedotin have demonstrated robust anti-tumor activity in R/M NPC. Phase II clinical data showed that single-agent becotatug vedotin achieved an objective response rate (ORR) close to 47%, and its combination with PD-1 inhibitors yielded an ORR as high as 66.7% in heavily pretreated NPC patients with manageable adverse reactions. Based on this preclinical and early clinical evidence, investigators hypothesize that adding becotatug vedotin to PD-1 maintenance therapy can bring extra survival benefits to high-risk NPC patients with residual tumor burden after frontline chemoimmunotherapy.
Investigators previously analyzed real-world and clinical trial data of patients receiving PD-1 monotherapy maintenance and verified the limited efficacy of single-agent immunotherapy in subjects with SD or persistent positive EBV DNA after first-line treatment. This study aims to design a prospective, multicenter, randomized controlled Phase III clinical trial to evaluate the efficacy and safety of maintenance therapy with becotatug vedotin combined with anti-PD-1 antibody versus single-agent anti-PD-1 antibody for recurrent and metastatic nasopharyngeal carcinoma patients who achieved stable disease or positive plasma EBV DNA following first-line chemotherapy plus anti-PD-1 treatment.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- Anti-PD1, Anti-PD1 combined with Becotatug Vedotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD1Drug
Anti-PD1 : Intravenous infusion on Day 1 of each 21-day cycle, administered for up to 2 years.
Anti-PD1 combined with Becotatug VedotinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Anti-PD1 maintenance group | Active comparator | days 1, 21 days/cycle, administered for up to 2 years Receives: 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. Receives: Drug: Anti-PD1 combined with Becotatug Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From randomization to 10 months
Secondary outcomes (6)
overall survival
Defined as the time from the date of randomization to the date of death from any cause.
Measured: From randomization to 3 years
Second-line progression-free survival
Defined as the time from randomization until the patient develops second disease progression or dies from any cause.
Measured: From enrollment to 20 months
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.
Measured: From enrollment to the end of treatment at 3 weeks
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)
Measured: From enrollment to the end of treatment at 3 weeks
Disease control rate
Per RECIST v1.1, DCR refers to the proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD).
Measured: From enrollment to the end of treatment at 3 weeks
Incidence of Treatment-Emergent Adverse Events
Adverse events (AEs) will be defined and graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0). Safety and tolerability will be evaluated for all subjects who receive at least one dose of study treatment.
Measured: From enrollment to the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion20 Jul 2028 (estimated)
- Study completion20 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIANG YANQUN, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705243
- Sponsor's protocol ID
- SYSKY-2026-289-02
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07705243
- Acronym / sponsor ID
- SYSKY-2026-289-02
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 20 Jul 2028 (estimated)
- Study completion
- 20 Jul 2029 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The therapeutic outcomes of patients with recurrent and metastatic nasopharyngeal carcinoma (R/M NPC) remain unsatisfactory for high-risk subgroups after standard first-line chemoimmunotherapy. Numerous previous studies have shown that anti-PD-1 immune checkpoint inhibitors (ICIs) deliver prominent anti-tumor activity in frontline treatment for R/M NPC. Large-scale Phase III trials including CAPTAIN-1st, JUPITER-02 and RATIONALE-309 confirmed that chemotherapy combined with PD-1 monoclonal antibodies greatly prolonged patients' progression-free survival (PFS) and became the standard first-line regimen. However, a large proportion of patients only reach stable disease (SD) or retain positive plasma EBV DNA after 4-6 cycles of chemoimmunotherapy, and single PD-1 maintenance barely offers durable tumor control for this population, with median PFS shorter than 5 months.
In addition, antibody-drug conjugates (ADCs) represented by becotatug vedotin have demonstrated robust anti-tumor activity in R/M NPC. Phase II clinical data showed that single-agent becotatug vedotin achieved an objective response rate (ORR) close to 47%, and its combination with PD-1 inhibitors yielded an ORR as high as 66.7% in heavily pretreated NPC patients with manageable adverse reactions. Based on this preclinical and early clinical evidence, investigators hypothesize that adding becotatug vedotin to PD-1 maintenance therapy can bring extra survival benefits to high-risk NPC patients with residual tumor burden after frontline chemoimmunotherapy.
Investigators previously analyzed real-world and clinical trial data of patients receiving PD-1 monotherapy maintenance and verified the limited efficacy of single-agent immunotherapy in subjects with SD or persistent positive EBV DNA after first-line treatment. This study aims to design a prospective, multicenter, randomized controlled Phase III clinical trial to evaluate the efficacy and safety of maintenance therapy with becotatug vedotin combined with anti-PD-1 antibody versus single-agent anti-PD-1 antibody for recurrent and metastatic nasopharyngeal carcinoma patients who achieved stable disease or positive plasma EBV DNA following first-line chemotherapy plus anti-PD-1 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-PD1 maintenance group | Active comparator | Drug: Anti-PD1days 1, 21 days/cycle, administered for up to 2 years |
| Anti-PD1 plus Becotatug Vedotin maintenance group | Experimental | Drug: Anti-PD1 combined with Becotatug VedotinAnti-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-PD1Anti-PD1 : Intravenous infusion on Day 1 of each 21-day cycle, administered for up to 2 years. | Drug | Anti-PD1 maintenance group |
| Anti-PD1 combined with Becotatug VedotinAnti-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. | Drug | Anti-PD1 plus Becotatug Vedotin maintenance group |
Primary outcome
Progression free survival
Time frame: From randomization to 10 months
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
6 secondary outcomes
overall survival
Time frame: From randomization to 3 years
Second-line progression-free survival
Time frame: From enrollment to 20 months
Duration of response
Time frame: From enrollment to the end of treatment at 3 weeks
Objective response rate
Time frame: From enrollment to the end of treatment at 3 weeks
Disease control rate
Time frame: From enrollment to the end of treatment at 3 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: From enrollment to the end of treatment at 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anti-PD1 and Anti-PD1 combined with Becotatug Vedotin in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu Guoying (18127919832, liugy0109@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From randomization to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.