This prospective, single-arm, multicenter phase II trial aims to evaluate the efficacy and safety of neoadjuvant beccotatug vedotin combined with pucotenlimab and cisplatin in patients with locally advanced epidermal growth factor receptor (EGFR)-positive head and neck squamous cell carcinoma (HNSCC). A total of 40 treatment-naive patients aged 18-70 years with stage III-IV (AJCC 8th edition) EGFR-positive HNSCC will be enrolled. Participants will receive three 3-week cycles of the triple-drug regimen. Tumor response will be reassessed after cycle 3 using RECIST v1.1. Patients achieving a complete or partial response (CR/PR) may proceed to de-escalation surgery followed by definitive chemoradiotherapy, or to definitive chemoradiotherapy alone; non-responders will undergo radical surgery with or without radiotherapy/chemoradiotherapy, or definitive chemoradiotherapy, as determined by multidisciplinary team (MDT) discussion. The primary endpoint is objective response rate (ORR). Secondary endpoints include major pathological response (MPR), pathological complete response (pCR), disease control rate (DCR), 2-year progression-free survival (PFS), 2-year overall survival (OS), quality of life, and safety. This study aims to provide preliminary evidence on the feasibility and activity of this novel triple combination in the neoadjuvant setting, potentially offering a new treatment paradigm to improve long-term outcomes and reduce recurrence.
This is a prospective, single-arm, multicenter phase II trial evaluating the efficacy and safety of neoadjuvant beccotatug vedotin combined with pucotenlimab and cisplatin in patients with locally advanced epidermal growth factor receptor (EGFR)-positive head and neck squamous cell carcinoma (HNSCC). A total of 40 treatment-naïve patients aged 18-70 years with stage III-IV (AJCC 8th edition) EGFR-positive (IHC) HNSCC will be enrolled. Participants receive 3 cycles (every 3 weeks) of beccotatug vedotin, pucotenlimab, and cisplatin. After 3 cycles, tumor response is reassessed by RECIST v1.1. Responders (CR/PR) may proceed to de-escalation surgery plus definitive chemoradiotherapy or definitive chemoradiotherapy alone, while non-responders undergo radical surgery ± radiotherapy/chemoradiotherapy or definitive chemoradiotherapy as per multidisciplinary team (MDT) discussion. The primary endpoint is objective response rate (ORR). Secondary endpoints include major pathological response (MPR), pathological complete response (pCR), disease control rate (DCR), 2-year progression-free survival (PFS), 2-year overall survival (OS), quality of life (EORTC QLQ-C30 and QLQ-H\&N35), and safety (NCI-CTCAE v5.0). This study aims to provide preliminary evidence on the feasibility and activity of this novel triple combination in the neoadjuvant setting, potentially offering a new treatment paradigm to improve long-term outcomes and reduce recurrence.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Becotatug vedotin is an EGFR-directed antibody-drug conjugate (ADC) comprising a humanized anti-EGFR monoclonal antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable valine-citrulline linker. It binds to EGFR-overexpressing tumor cells, undergoes receptor-mediated internalization, and releases MMAE to inhibit microtubule polymerization, inducing cell cycle arrest and apoptosis. Pucotenlimab is a humanized anti-PD-1 monoclonal antibody that blocks the PD-1/PD-L1 interaction, restoring T-cell-mediated antitumor immune responses. Cisplatin is a platinum-based alkylating agent that forms DNA crosslinks, leading to cell death. These three agents are administered as sequential intravenous infusions on Day 1 of each 21-day cycle: pucotenlimab 200 mg, followed by beccotatug vedotin 2.0 mg/kg, and cisplatin 60 mg/m². The regimen is given for up to 3 neoadjuvant cycles prior to definitive local therapy.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGObjective response rate
Objective response rate defined as the proportion of patients achieving a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 after neoadjuvant therapy.
Time frame: After 3 cycles of neoadjuvant therapy (approximately 9 weeks)
Major Pathological Response (MPR)
MPR is defined as the presence of ≤10% viable residual tumour cells in the surgical specimen after neoadjuvant therapy.
Time frame: At the completion of definitive surgery
Pathological Complete Response (pCR)
pCR means the complete absence of invasive tumour cells in the resected primary tumour and all sampled regional lymph nodes (ypT0ypN0).
Time frame: At the completion of definitive surgery
Disease Control Rate (DCR)
DCR is the proportion of patients who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1, maintained for a specified duration.
Time frame: After 3 cycles of neoadjuvant therapy (approximately 9 weeks)
2-Year Progression-Free Survival (PFS)
PFS is the time from treatment initiation (or randomisation) until the first occurrence of disease progression (per RECIST v1.1) or death from any cause.
Time frame: Up to 2 years
2-Year Overall Survival (OS)
Definition: OS is the time from treatment initiation to death from any cause.
Time frame: Up to 2 years
Health-Related Quality of Life assessed by the EORTC QLQ-C30
Quality of life and functional status are assessed using the validated EORTC QLQ-C30 (version 3.0). All scores are linearly transformed to a 0-100 scale; higher scores indicate better global health status and functioning, but worse symptom burden. Administered per the standard EORTC scoring manual.
Time frame: 2 years
EORTC QLQ-H&N35 Module
Head and neck cancer-specific quality of life is assessed using the validated EORTC QLQ-H\&N35 module. All item scores are linearly transformed to a 0-100 scale. For this module, higher scores indicate worse symptom burden and poorer quality of life. The questionnaire is administered per the standard EORTC manual.
Time frame: 2 years
Safety Endpoints (Safety Profiles)
This includes the incidence, severity, and attribution of adverse events (AEs), serious adverse events (SAEs), treatment-related AEs, dose modifications, delays, and discontinuations.
Time frame: 2 years
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