Becotatug vedotin added to radiation and adjuvant therapy for locally advanced nasopharyngeal cancer with a poor response to induction chemo‑immunotherapy

Becotatug Vedotin for Locoregionally Advanced Nasopharyngeal Carcinoma With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy: A Prospective, Single-Arm, Phase II Trial

This will test whether adding becotatug vedotin during radiation and afterward helps people with locally advanced nasopharyngeal cancer who had a suboptimal response to induction chemotherapy combined with immunotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07496190 on ClinicalTrials.gov

What this trial studies

This is a prospective, single‑arm Phase II study enrolling patients with high‑risk locally advanced non‑keratinizing nasopharyngeal carcinoma who show a suboptimal response after three cycles of induction chemo‑immunotherapy. Suboptimal response is defined by detectable plasma EBV DNA (>0 copies/mL) or imaging showing stable or progressive disease. Participants will receive becotatug vedotin added during the concurrent radiotherapy phase and the adjuvant phase to test whether this different mechanism of action improves outcomes. The goal is to collect evidence-based data on safety and efficacy to determine whether this regimen can be an additional option for these higher‑risk patients.

Who should consider this trial

Good fit: Adults aged 18–70 with pathologically confirmed non‑keratinizing locally advanced nasopharyngeal carcinoma (AJCC 9th edition Any T N2‑3 or T4N1), ECOG 0–1, no distant metastasis, and a suboptimal response after three cycles of induction immunochemotherapy are eligible.

Not a fit: Patients who responded well to induction therapy, those with distant metastatic disease, significant organ dysfunction, pregnant individuals, or those outside the age limits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding becotatug vedotin could improve disease control and survival for high‑risk patients who do not respond well to induction chemo‑immunotherapy.

How similar studies have performed: Becotatug vedotin is an antibody‑drug conjugate with limited prior data in nasopharyngeal cancer; while similar ADCs have shown activity in other tumor types, this specific approach in suboptimal responders is relatively novel and largely unproven.

Eligibility criteria

Inclusion Criteria:

* Voluntary participation and written informed consent must be signed.
* Age between 18 and 70 years, male or non-pregnant female.
* Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
* Stage Any T N2-3 or T4N1 (AJCC 9th edition), with no distant metastasis, and previously untreated nasopharyngeal carcinoma.
* Efficacy after 3 cycles of induction immunochemotherapy assessed as stable disease (SD) or progressive disease (PD) by nasopharyngoscopy and contrast-enhanced MRI of the nasopharynx and neck.
* ECOG performance status score of 0 or 1.
* Adequate hematological function: Hemoglobin (HGB)≥90g/L, White Blood Cell (WBC) ≥ 4.010\^9/L, and Platele (PLT) ≥10010\^9/L.
* Adequate hepatic function: ALT and AST≤2.5Upper Limit of Normal (ULN), total bilirubin ≤2.0ULN, and serum albumin≥30g/L.
* Adequate renal function: Serum creatinine ≤ 1.5\*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
* International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 \*ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening).

Exclusion Criteria:

* Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
* Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
* Patients who have previously received radiotherapy or systemic chemotherapy.
* Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.
* HIV positive.
* History of other malignancies (except for cured basal cell carcinoma or cervical carcinoma in situ).
* Patients who have previously received immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Pei-Yu Huang

Conditions Nasopharyngeal Cancinoma; high-risk locally advanced nasopharyngeal carcinoma