Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEye & ENT Hospital of Fudan University
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
Received systemic chemotherapy, but excluding chemotherapy for locally advanced disease as a part of multimodal treatment. Note: Chemotherapy for locally advanced disease includes induction chemotherapy, radiotherapy with concurrent chemotherapy, and adjuvant chemotherapy;
Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways;
Previous use of anti-EGFR drugs such as cetuximab, nimotuzumab, gefitinib, and afatinib;
Pregnant or lactating, or planning to become pregnant during the study period;
Trial design
Treatments tested in this trial
- Penpulimab combined with cetuximab
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov