An Exploratory Clinical Study to Evaluate the Efficacy and Safety of Penpulimab in Combination With Cetuximab as First-line Treatment in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/MSCCHN)

Who is this study for? Patients with Head and Neck Cancer
What treatments are being studied? Penpulimab+Cetuximab
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This trial is a multicenter, prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of Penpulimab injection combined with cetuximab in the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age: ≥ 18 years, male or female;

• Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx) (SCCHN);

• Recurrent/metastatic SCCHN not suitable for local treatment such as surgery or radiotherapy in the opinion of the investigator;

• At least one measurable tumor lesion according to RECIST 1.1 criteria;

• The tumor expresses PD-L1, with a comprehensive positive score CPS ≥ 1;

• Eastern Cooperative Oncology Group (ECOG) PS: 0-1

• Expected survival ≥ 3 months;

• Normal function of major organs, meeting the following criteria: blood routine examination criteria must be met: (no blood transfusion within 14 days before screening) 1) HB ≥ 90 g/L; 2) ANC ≥ 1.5 × 109/L; 3) PLT ≥ 75 × 109/L; biochemistry: (without transfusion or blood product within 14 days before screening) 1) BIL ≤ 1.5 × upper limit of normal (ULN) (≤ 3 × ULN for patients with Gilbert's syndrome); 2) ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis); 3) Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50ml/min (Cockcroft-Gault formula); 4) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; left ventricular ejection fraction (LVEF) ≥ 50% assessed by cardiac Doppler ultrasound;

• Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and are willing to use reliable contraception during the trial and must be non-lactating patients; male subjects must use reliable contraception from the start of treatment to 6 months after the last dose;

• The subjects voluntarily join the study, sign the ICF, have good compliance, and cooperate in the follow-up

Locations
Other Locations
China
Department of radiotherapy,The First Bethune Hospital of Jilin University
RECRUITING
Changchun
Department of Radiotherapy, Eye & ENT Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Xiaoshen Wang
ruijin702@163.com
18917785187
Time Frame
Start Date: 2022-01-25
Estimated Completion Date: 2026-12-25
Participants
Target number of participants: 48
Treatments
Experimental: Penpulimab+cetuximab
Erbitux 500 mg/m2 without immunotherapy for 14 days prior to the first cycle. Cetuximab Injection 500 mg/m2 and Penpulimab Injection 200 mg are intravenously infused on Day 1 (D1) of Cycle 1, with 14 days as one cycle. Penpulimab for up to 96 weeks (48 cycles)
Sponsors
Leads: Eye & ENT Hospital of Fudan University

This content was sourced from clinicaltrials.gov