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Phase II Multi-centered Study of Perioperative Ivonescimab Versus Pembrolizumab Combined with Standard of Care (SOC) in Patients with Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT06814067 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-02-07

No results posted yet for this study

Summary

Head and neck squamous cell carcinoma (HNSCC) is one of the common malignant tumors in the world. More than 60% of HNSCC patients are locally advanced when first diagnosed. The treatment effect of locally advanced HNSCC is not ideal. About 50-60% of patients will have local recurrence within 2 years, and 20-30% of patients will have distant metastasis. The 5-year disease control rate is approximately 40%, and the 5-year overall survival rate is less than 50%.

In recent years, PD-1 inhibitors have shown significant efficacy in recurrent/metastatic HNSCC. The Keynote 040 and Checkmate 141 studies established the status of PD-1 inhibitors as second-line treatment in recurrent/metastatic HNSCC. The Keynote 048 study further established the value of PD-1 inhibitors alone or in combination with chemotherapy in the first-line treatment of recurrent/metastatic HNSCC. An increasing number of studies have attempted to explore the value of neoadjuvant therapy with PD-1 inhibitors in locally advanced HNSCC. For example,The Checkmate 358 study showed that the clinical objective response rate of neoadjuvant nivolumab monotherapy was 10.2%, and the major pathological response rate (MPR) was 2.9%.

Ivonescimab is a new PD-1/VEGF bispecific antibody drug, which can block both the PD-1 pathway and the VEGF pathway. This dual blocking mechanism is expected to enhance the efficacy of immunotherapy by improving the tumor microenvironment. Ivonescimab has been studied in Phase II to Phase III clinical studies in multiple tumor types such as lung cancer, breast cancer, and head and neck squamous cell carcinoma. For example, the HARMONi-2 study showed that ivocilizumab monotherapy had significantly better progression-free survival (PFS) than pembrolizumab in the treatment of PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). In recurrent and metastatic HNSCC, Ivonescimab alone or in combination with the CD47 monoclonal antibody Ligufalimab has better objective response rate (ORR) and disease control rate (DCR) than pembrolizumab.

The aim of this study is to compare the efficacy and safety of perioperative treatment with Ivonescimab and pembrolizumab in surgically resectable locally advanced head and neck squamous cell carcinoma.

Conditions

Interventions

DRUG

Pembrolizumab

Two cycles of neoadjuvant pembrolizumab (200mg q3w) followed by radical surgery. Adjuvant radiotherapy/chemoradiotherapy is decided based on pathological risk factors. Fifteen cycles of pembrolizumab (200mg q3w)maintenance therapy was given.

DRUG

Ivonescimab

Two cycles of neoadjuvant Ivonescimab (10mg/kg q3w) followed by radical surgery. Adjuvant radiotherapy/chemoradiotherapy is decided based on pathological risk factors. Fifteen cycles of Ivonescimab maintenance therapy (10mg/kg q3w) was given.

PROCEDURE

Surgery

Radical surgery

RADIATION

Adjuvant radiotherapy

Adjuvant radiotherapy with/without concurrent cisplatin-based chemotherapy, based on pathologic risk factors.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    collaborator OTHER_GOV

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2029-02-10
Completion
2030-03-01

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT06814067 on ClinicalTrials.gov