NCT06107114

Cetuximab+Zimberelimab in Combination With Cisplatin and Nab-paclitaxel in Resctable Head and Neck Squamous Cell Carcinoma

An Open, Single-center, Phase II Trial of Cetuximab+Zimberelimab Combined With Platinum-containing Dual-agent Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Xuekui Liu · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single arm phase ll trial including 52 patients with T2N2-3M0#T3-4N0-3M0 (III-V) head and neck squamous cell carcinoma(HNSCC) eligible forresection, who receive Cetuximab+ Zimberelimab combined with cisplatin and Nab.paclitaxel.This proposed study will evaluate the efficacy and safety of preoperative administration of Cetuximab+ Zimberelimab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma(HNSCC) who are about to undergo surgery.

Detailed description

In this study, eligible subject will be enrolled into study arm to accept study treatment objective response rate will be the primary outcome measures.

Conditions

• Hend and Neck Squamous Cell Carcinoma Locally Advanced Operable

Interventions

Type	Name	Description
DRUG	Cetuximab	Cetuximab 400mg/m2 (The first week), 250mg/m2(Follow-up weekly) The drug was administered every week (QW). The treatment regimen is recommended for three cycles until the researchers determine that the subjects cannot continue to benefit, until the disease progression (PD), the toxicity cannot be tolerated, the treatment is delayed by more than 14 days, or the patient withdraws the informed consent form or dies.
DRUG	Zimberelimab	Zimberelimab 240 mg, The drug was administered every week (Q3W), and 21 days (Q3W) was a treatment cycle. The treatment regimen is recommended for three cycles until the researchers determine that the subjects cannot continue to benefit, until the disease progression (PD), the toxicity cannot be tolerated, the treatment is delayed by more than 14 days, or the patient withdraws the informed consent form or dies.
DRUG	Docetaxel	Docetaxel 75mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.
DRUG	Cisplatin	Cisplatin 60mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2023-10-30
• Last updated: 2023-11-22

Locations

1 site across 1 country: China