A Phase 3 interventional study of Becotatug Vedotin and Pucotenlimab in Nasopharyngeal Cancinoma (NPC) and Nasopharyngeal Cancer, sponsored by Sun Yat-sen University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
This randomized controlled trial aims to evaluate the efficacy and safety of Becotatug Vedotin (MRG003), an antibody-drug conjugate (ADC), combined with the PD-1 inhibitor Pucotenlimab as induction therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (NPC), compared to the standard gemcitabine and cisplatin (GP) regimen combined with Pucotenlimab, followed by concurrent chemoradiotherapy (CCRT) and adjuvant immunotherapy.
Patients in the experimental arm will receive MRG003 (2.0 mg/kg, Day 1, Q3W × 3 cycles) plus Pucotenlimab (200 mg, Day 1, Q3W × 3 cycles) as induction therapy, followed by CCRT [intensity-modulated radiotherapy (IMRT): 70 Gy in 33 fractions, 5 days/week, once daily; cisplatin 100 mg/m², Day 1, Q3W × 2 cycles], and adjuvant Pucotenlimab (200 mg, Day 1, Q3W × 6 cycles). Patients in the control arm will receive gemcitabine (1000 mg/m², Days 1 and 8, Q3W × 3 cycles) plus cisplatin (80 mg/m², Day 1, Q3W × 3 cycles) and Pucotenlimab (200 mg, Day 1, Q3W × 3 cycles) as induction therapy, followed by the same CCRT regimen and adjuvant Pucotenlimab.
The primary objectives are to assess whether ADC-based induction therapy improves the post-induction therapy complete response rate (post-IT CRR) and event-free survival (EFS) compared to the GP-based standard of care. Secondary objectives include comparisons of overall survival (OS), distant metastasis-free survival (DMFS), and locoregional recurrence-free survival (LRRFS), as well as evaluation of the safety, tolerability, and quality of life associated with the MRG003-containing regimen.
240 studies on the registry are indexed under Nasopharyngeal Neoplasms; 47 are open to participants now.
This study's planned enrollment of 514 is above the median of 60 across 198 interventional studies indexed under Nasopharyngeal Neoplasms.
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1. Age ≥ 18 years at the time of diagnosis, regardless of sex
2. Histologically confirmed newly diagnosed nasopharyngeal carcinoma (NPC) of non-keratinizing carcinoma histology (WHO classification)
3. Locoregionally advanced NPC staged as T4N2 or T1-4N3 according to the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) 9th edition staging system. All patients must undergo the following evaluations prior to initiation of any treatment to confirm clinical staging: complete medical history and physical examination, complete blood count (CBC) and biochemistry panel, plasma Epstein-Barr virus (EBV) DNA titer and serology, nasopharyngoscopy, magnetic resonance imaging (MRI) of the head and neck, chest X-ray or computed tomography (CT) of the chest, abdominal ultrasound, and bone scintigraphy. 18F-fluorodeoxyglucose positron emission tomography/CT (¹⁸F-FDG PET/CT) may be used as a substitute for the latter three imaging modalities.
4. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
5. Willing to provide archived tumor tissue (primary or metastatic lesion, obtained within 2 years prior to enrollment) or fresh biopsy specimen. Patients unable to provide tumor tissue may still be enrolled at the investigator's discretion, provided all other eligibility criteria are met.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to first dose
7. Adequate organ function, as defined by the following laboratory parameters, obtained within 4 weeks prior to screening, with no blood transfusions, hematopoietic growth factors, or thrombopoietic agents administered during this period: a) Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; white blood cell count > 4 × 10⁹/L; hemoglobin > 90 g/L; platelet count > 100 × 10⁹/L; b) Hepatic and renal function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL/min; urinary protein ≤ 2+ or ≤ 1000 mg/24 hours; c) Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (patients receiving stable low-dose anticoagulation therapy, such as aspirin 100 mg/day, are permitted)
8. Normal findings on thyroid function tests, serum amylase and lipase, pituitary function tests, inflammatory and infectious markers, cardiac enzyme panel, and electrocardiogram (ECG): a) Patients aged > 50 years with a smoking history must have normal pulmonary function test results; b) Patients with ECG abnormalities or a prior cardiovascular history (not meeting exclusion criteria) must additionally undergo myocardial function testing and echocardiography, with normal results required for enrollment
9. Willing and able to provide written informed consent and to comply with all protocol-specified requirements, including scheduled visits, treatment administration, laboratory assessments, and other study procedures
10. Patients of reproductive potential must agree to use effective contraception from the time of informed consent through 6 months after the last dose of study treatment. Women of childbearing potential (WOCBP), defined as premenopausal women and women within 2 years of menopause, must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment.
Exclusion Criteria:
1. History of any other malignancy within the past 5 years, with the exception of curatively treated cervical carcinoma in situ, papillary thyroid carcinoma, or basal cell carcinoma of the skin
2. Prior receipt of any anti-tumor therapy for nasopharyngeal carcinoma, or any of the following: a) Any ADC drug with a monomethyl auristatin E (MMAE) payload within 3 months prior to first dose; b) Any investigational drug from another clinical trial within 28 days prior to first dose; c) Major surgery within 28 days prior to first dose without full recovery, or planned major surgery within the first 12 weeks after initiation of study treatment
3. Positive human immunodeficiency virus antibody (HIV-Ab); active tuberculosis; active hepatitis B virus infection (HBV-DNA > 1 × 10³ copies/mL); or active hepatitis C virus infection (HCV antibody positive and HCV-RNA above the lower limit of detection)
4. History of primary immunodeficiency, or active autoimmune disease requiring immunosuppressive therapy or systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment. The following conditions are exempt: type 1 diabetes mellitus; hypothyroidism (including autoimmune thyroid disease) stable on hormone replacement therapy; psoriasis, vitiligo, or alopecia not requiring systemic treatment; and use of topical or inhaled corticosteroids, or short-term (≤ 7 days) systemic corticosteroids for prophylaxis or treatment of non-autoimmune, non-recurrent allergic conditions
5. Uncontrolled cardiac disease, including any of the following: (1) heart failure of New York Heart Association (NYHA) Class ≥ 2; (2) unstable angina; (3) myocardial infarction within the past 1 year; (4) prolonged QT interval (QTc > 450 ms in males or QTc > 470 ms in females), complete left bundle branch block, third-degree atrioventricular block, or supraventricular or ventricular arrhythmia requiring treatment or intervention
6. Hypertension inadequately controlled with two antihypertensive agents (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg)
7. Poorly controlled blood glucose, defined as: (a) fasting blood glucose > 10 mmol/L on two occasions, or (b) glycated hemoglobin (HbA1c) > 8%; or concurrent diabetic gangrene
8. History of interstitial lung disease (ILD) or pulmonary inflammation requiring steroid treatment (including pulmonary fibrosis and radiation pneumonitis), current ILD or pulmonary inflammation, or imaging findings at screening that cannot exclude suspected ILD or pulmonary inflammation
9. Concurrent pulmonary disease causing clinically severe respiratory impairment, including but not limited to: (a) any underlying pulmonary condition (e.g., pulmonary embolism, severe asthma, or severe chronic obstructive pulmonary disease [COPD] within 3 months prior to screening); (b) restrictive lung disease; (c) history of or concurrent interstitial pneumonitis, radiation pneumonitis, severe COPD, severe pulmonary insufficiency, or symptomatic bronchospasm
10. Unstable thromboembolic events requiring therapeutic intervention within 6 months prior to screening, including deep vein thrombosis, arterial thrombosis, or pulmonary embolism; catheter-related thrombosis is exempt
11. Pregnant or breastfeeding women (pregnancy testing should be considered for sexually active women of childbearing potential)
12. Known hypersensitivity to any component of Pucotenlimab or Becotatug Vedotin (MRG003) (including histidine, histidine hydrochloride, sucrose, mannitol, and polysorbate 80), or a history of Grade ≥ 3 hypersensitivity reaction to any macromolecular protein preparation or monoclonal antibody
13. Serious infection (CTCAE Grade > 2) within 4 weeks prior to first dose, including but not limited to severe pneumonia, bacteremia, sepsis, or active tuberculosis
14. Pre-existing peripheral neuropathy of Grade > 1
15. Receipt of a live vaccine within 30 days prior to first dose of Becotatug Vedotin (MRG003)
16. Prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT)
17. Any other condition judged by the investigator to potentially compromise patient safety or compliance, including but not limited to serious medical conditions requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory findings, or other psychological, familial, or social high-risk factors
Induction Therapy (3 cycles, Q3W): Becotatug Vedotin (MRG003) 2.0 mg/kg, intravenous infusion, Day 1 + Pucotenlimab 200 mg, intravenous infusion, Day 1; Concurrent Chemoradiotherapy (CCRT): Intensity-modulated radiotherapy (IMRT): 70 Gy in 33 fractions, once daily, 5 days per week + Cisplatin 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W); Adjuvant Immunotherapy (6 cycles, Q3W): Pucotenlimab 200 mg, intravenous infusion, Day 1
Drug: Becotatug Vedotin · Drug: Pucotenlimab · Radiation: intensity-modulated radiotherapy · Drug: Cisplatin
Induction Therapy (3 cycles, Q3W): Gemcitabine 1000 mg/m², intravenous infusion, Days 1 and 8 + Cisplatin 80 mg/m², intravenous infusion, Day 1 + Pucotenlimab 200 mg, intravenous infusion, Day 1; Concurrent Chemoradiotherapy (CCRT): Intensity-modulated radiotherapy (IMRT): 70 Gy in 33 fractions, once daily, 5 days per week + Cisplatin 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W); Adjuvant Immunotherapy (6 cycles, Q3W): Pucotenlimab 200 mg, intravenous infusion, Day 1
Drug: Pucotenlimab · Drug: Gemcitabine + cisplatin (GP) · Radiation: intensity-modulated radiotherapy · Drug: Cisplatin
Induction Therapy: Becotatug Vedotin (MRG003) 2.0 mg/kg, intravenous infusion, Day 1 (3 cycles, Q3W)
Induction Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (3 cycles, Q3W); Adjuvant Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (6 cycles, Q3W)
Induction Therapy (3 cycles, Q3W): Gemcitabine 1000 mg/m², intravenous infusion, Days 1 and 8 Cisplatin 80 mg/m², intravenous infusion, Day 1
70 Gy in 33 fractions, once daily, 5 days per week
Concurrent Cisplatin: 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W) during radiation
Post-induction Therapy Complete Response Rate (post-IT CRR)
The proportion of patients achieving complete response following induction therapy
Time frame: Within 9 to 21 days after the last dose of induction therapy
Event-Free Survival (EFS)
From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.
Time frame: 3 years & 5 years
Overall survival (OS)
From date of enrollment to date of death from any cause
Time frame: 3 years & 5 years
Distant Metastasis-Free Survival (DMFS)
From date of enrollment to date of first documented distant metastasis
Time frame: 3 years & 5 years
Locoregional Recurrence-Free Survival (LRRFS)
From date of enrollment to date of first documented locoregional recurrence
Time frame: 3 years & 5 years
Adverse Events (AEs)
Graded according to CTCAE V5.0
Time frame: 3 years & 5 years
Patient-Reported Adverse Events (PRO-CTCAE)
Patient-reported adverse events will be assessed using selected items from the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE™), Chinese version, administered at each treatment cycle. Patients will self-report and rate the severity of relevant adverse events throughout the study treatment period.
Time frame: At the end of each treatment cycle (each cycle is 21 days), from Cycle 1 of induction therapy through Cycle 6 of adjuvant therapy
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Assesses general quality of life in cancer patients. Items are scored and linearly transformed to a 0-100 scale. For functional scales, higher scores indicate better functioning; for symptom scales, higher scores indicate greater symptom burden.
Time frame: At baseline, after completion of induction therapy (Week 10), mid-IMRT(Week 16), after completion of IMRT (Week 19), at the last adjuvant cycle (Week 34; each cycle is 21 days), and at 3, 12, 24, 36, 48, and 60 months post-radiotherapy
EORTC Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H&N35, version 1)
Assesses head and neck cancer-specific symptoms. Items are scored and linearly transformed to a 0-100 scale. Higher scores indicate more severe symptoms.
Time frame: At baseline, after completion of induction therapy (Week 10), mid-IMRT(Week 16), after completion of IMRT (Week 19), at the last adjuvant cycle (Week 34; each cycle is 21 days), and at 3, 12, 24, 36, 48, and 60 months post-radiotherapy
Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N, Chinese version 4)
Assesses quality of life specific to head and neck cancer patients. Items are rated on a 0-4 scale and summed to a total score of 0-156. Higher scores indicate better quality of life.
Time frame: At baseline, after completion of induction therapy (Week 10), mid-IMRT(Week 16), after completion of IMRT (Week 19), at the last adjuvant cycle (Week 34; each cycle is 21 days), and at 3, 12, 24, 36, 48, and 60 months post-radiotherapy
Correlation of Tumor, Peripheral Blood, and Fecal Biomarkers with Treatment Efficacy and Patient Prognosis
Tumor tissue biomarkers: EGFR expression level, PD-L1 expression level, tumor-infiltrating lymphocyte (TIL) density, immune score, expression profiles of immune checkpoint molecules and immune cell subpopulations, and tumor cell transcriptomic gene expression； Peripheral blood biomarkers: Immune cell populations, immune repertoire, and cytokine profiles； Fecal biomarkers: Composition and characteristics of fecal biomarkers in relation to treatment response and prognosis
Time frame: 3 years & 5 years
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Sun Yat-sen University