NCT05260671

Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Based on the apparent efficacy and favorable safety profile of previous PD-1 and cetuximab combination therapy, Penpulimab (PD-1 antibody) combined with cetuximab in the first-line treatment of patients with recurrent/metastatic SCCHN are used to assess the efficacy and safety of the regimen. Among them, Penpulimab (PD-1 antibody) is approved for adult patients with relapsed or refractory classical Hodgkin's lymphoma who have received at least second-line systemic chemotherapy in China. Cetuximab is approved in China for first-line treatment of recurrent/metastatic SCCHN in combination with chemotherapeutic drugs platinum and fluorouracil. This study plans to enroll 48 patients with untreated recurrent/metastatic squamous cell carcinoma of the head and neck who will receive Penpulimab injection combined with cetuximab. Cetuximab 500 mg/m2 without PD-1 drugs for 14 days prior to Cycle 1. Cetuximab Injection 500 mg/m2 and Penpulimab Injection 200 mg are intravenously infused on Day 1 (D1) of Cycle 1, with 2 weeks (14 days) as a cycle. Penpulimab will be administered for no more than 96 weeks (48 cycles), and cetuximab will be administered until disease progression, unacceptable toxicity, or withdrawal decision by the subject.

Conditions

• Head and Neck Neoplasms
• Recurrent Disease
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Penpulimab combined with cetuximab	PD-1 antibody combined with EGFR inhibitors, biweekly

Timeline

• Start date: 2022-01-25
• Primary completion: 2024-12-25
• Completion: 2026-12-25
• First posted: 2022-03-02
• Last updated: 2023-10-18

Locations

2 sites across 1 country: China