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Becotatug Vedotin Combined With Pucotenlimab for Locally Recurrent Resectable Head and Neck Squamous Cell Carcinoma

NCT07632339 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-06-08

No results posted yet for this study

Summary

This is a multicenter, randomized, controlled, Phase II clinical study designed to evaluate the efficacy and safety of neoadjuvant and adjuvant therapy with vebikotamab combined with Pucotenlimab compared to standard treatment in patients with locally recurrent resectable head and neck squamous cell carcinoma (HNSCC).

Investigational Arm:

The dosing regimen for the investigational arm is as follows:

Pucotenlimab: 200 mg per dose, administered intravenously (IV) every 3 weeks (Q3W). No dose adjustments are permitted; however, dosing delays are allowed up to a maximum of 12 weeks from the date of the previous dose. This is administered for two preoperative cycles.

Becotatug Vedotin: 2.3 mg/kg, administered IV Q3W for two preoperative cycles.

Following neoadjuvant therapy, patients will undergo surgery at 4 weeks ± 7 days. Postoperatively (at 6 weeks ± 3 weeks), patients will be stratified for adjuvant therapy based on pathological response:

Patients who achieve a major pathological response (MPR) and have no high-risk factors will receive 6 cycles of single-agent adjuvant Pucotenlimab (200 mg/dose, Q3W).

Patients who do not achieve MPR or who present with high-risk factors will receive standard postoperative adjuvant therapy.

Control Arm:

Patients in the control arm will undergo upfront surgery followed by standard adjuvant therapy.

Conditions

Interventions

DRUG

Becotatug Vedotin combined with Pucotenlimab

patients received 2 cycles of Pucotenlimab(200 mg per dose, q3w) and Becotatug Vedotin (2.3 mg/kg, Q3W) in the neoadjuvant stage, then patients will undergo surgery at 4 weeks ± 7 days. Postoperatively (at 6 weeks ± 3 weeks), patients will be stratified for adjuvant therapy based on pathological response: Patients who achieve a major pathological response (MPR) and have no high-risk factors will receive 6 cycles of single-agent adjuvant Pucotenlimab (200 mg/dose, Q3W). Patients who do not achieve MPR or who present with high-risk factors will receive standard postoperative adjuvant therapy.

PROCEDURE

surgery

Patients in the control arm will undergo upfront surgery followed by standard adjuvant therapy.

Sponsors & Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    lead OTHER

Principal Investigators

  • Yue He, M.D. · the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-16
Primary Completion
2028-06-16
Completion
2029-06-16

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07632339 on ClinicalTrials.gov