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

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

NCT ID: NCT06107114

Condition: Hend and Neck Squamous Cell Carcinoma Locally Advanced Operable

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Docetaxel
Cetuximab

Conditions: Keywords:
head and neck squamous cell carcinoma
Cetuximab
Zimberelimab
neoadjuvant therapy

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cetuximab
Description: 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.
Arm group label: Experimental group

Intervention type: Drug
Intervention name: Zimberelimab
Description: 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.
Arm group label: Experimental group

Intervention type: Drug
Intervention name: Docetaxel
Description: 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.
Arm group label: Experimental group

Intervention type: Drug
Intervention name: Cisplatin
Description: 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.
Arm group label: Experimental group

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Newly diagnosed primary head and neck squamous cell carcinoma confirmed by histology and/or cytology (excluding diagnostic therapy). 2. Clinical stage:T2N2-3M0,T3-4N0-3M0 (AJCC 8th editionstaging). 3. Age: 18 to 70 years. 4. PS score (see Appendix Table 1; performance status score of 0 or 1). 5. Patients evaluated by a head and neck oncologist as resectable with no distant metastases. 6. Patients with at least one measurable lesion according to RECIST version 1.1 criteria. 7. Patients' toxicities assessed according to CTCAE version 4.03 criteria. 8. Patients with normal organ function (heart,brain, lungs, kidneys) and suitable for surgery: 1. Hematology: White blood cells ≥ 3500/μL,neutrophils ≥1,800/pL, hemoglobin ≥ 9 g/dL, platelets ≥100,000/μL; 2. Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin levels ≤ 3 times ULN can be included), AST and ALT ≤3 times ULN, alkaline phosphatase ≤ 3 times ULN; albumin ≥ 3 g/dL; c.Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min according to Cockcroft-Gault formula. 9. Patients have signed an informed consent form, are willing and able to comply with the study's visit, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: 1. History of severe hypersensitivity reactions to components of other monoclonal antibodies, CTLA4, or PD-1 antibodies. 2. Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures. 3. Recurrence, distant metastasis, or the inability to undergo surgery as assessed by a head and neck physician. 4. Abnormal coagulation function:(PT > 16s,APTT>53s,TT> 21s, Fib < 1.5g/L), bleeding tendency, or currently on anticoagulant or thrombolytic therapy. 5. Severe heart disease, pulmonary dysfunction, patients with heart or lung function below Grade 3 (including Grade 3). 6. Laboratory values not meeting relevant criteria within 7 days prior to enrollment. 7. Previous use of anti-PD-1 antibodies, anti-PD-L1 antibodies,anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies targeting T cell co-stimulation or checkpoint pathways). 8. Pre-existing conditions requiring long-term use of immunosuppressive drugs or a need for systemic or local use of corticosteroids at immunosuppressive doses prior to enrollment. 9. HIV-positive individuals;HBsAg-positive individuals with positive HBV DNA copy number (quantitative test≥1000 cps/ml); positive chronic hepatitis C blood screening(HCV antibody positive). 10. Traditional herbal medicine used for anti-tumor purposes within 4 weeks before randomization. 11. Women of childbearing potential with a positive pregnancy test and breastfeeding women.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Sun Yat-sen University

Address:
City: Guangzhou
Country: China

Start date: December 1, 2023

Completion date: December 1, 2024

Lead sponsor:
Agency: Xuekui Liu
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06107114