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

Conditions

• Head and Neck Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Becotatug Vedotin combined with Pucotenlimab — DRUG
  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.
• surgery — PROCEDURE
  Patients in the control arm will undergo upfront surgery followed by standard adjuvant therapy.

Study Details

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.

Key Dates

First listed

Jun 8, 2026

Start date

Jun 16, 2026

Status verified

Jun 2026

Primary completion

Jun 16, 2028

Completion

Jun 16, 2029

Study Design

Enrollment

102 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Neoadjuvant treatment arm
  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.
• Active Comparator: Standard treatment arm
  Patients in the control arm will undergo upfront surgery followed by standard adjuvant therapy.

Primary Outcome Measure

1 year events free survival rate [ Time Frame: 24 months ]

Central Contacts

• Guoxin Ren, M.D.
  13916948812
  [email protected]

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