Health TrialsbyHealthPanel

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

ConditionsHead and Neck NeoplasmsRecurrent DiseaseMetastatic Cancer
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Penpulimab combined with cetuximab

    Drug

    PD-1 antibody combined with EGFR inhibitors, biweekly

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Penpulimab+cetuximabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate

Defined as the percentage of complete response (CR) or partial response (PR) (i.e., CR + PR) evaluated according to RECIST v1.1 from the start of trial medication

Time frame
2 years

Secondary outcomes

1

Overall survival

Time from start of trial medication to death due to any cause.

Time frame
2 years
2

Progression-free survival

Defined as the time from the start of trial medication to either PD as assessed by RECIST v 1.1 or death due to any cause, whichever comes first.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eye & ENT Hospital of Fudan University

Lead sponsor

Source ClinicalTrials.gov
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