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

NCT05260671 | Recruiting Phase 2

• 1 other identifier: P-C-SCCHN
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Head and Neck Neoplasms; Recurrent Disease; Metastatic Cancer

Outcome Measures

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

  2 years

Secondary Outcomes (2)

• Overall survival

  2 years

• Progression-free survival

  2 years

Study Arms (1)

Penpulimab+cetuximab

EXPERIMENTAL

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)

Drug: Penpulimab combined with cetuximab

Interventions

Penpulimab combined with cetuximab DRUG

PD-1 antibody combined with EGFR inhibitors, biweekly

Also known as: AK105+Erbitux

Penpulimab+cetuximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Current participation and receipt of study treatment, or participation in an investigational drug trial or use of an investigational device within 4 weeks prior to randomization;
• Presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which may present with clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth;
• Any active autoimmune disease or history of autoimmune disease (but not limited to autoimmune hepatitis, interstitial pneumonia, enteritis, hypophysitis, vasculitis, nephritis; positive HIV test or history of the above diseases, or history of organ transplantation; but the following patients are allowed: vitiligo, psoriasis, alopecia, well-controlled type I diabetes mellitus, Hypothyroidism with euthyroidism treated by replacement therapy;
• Treatment with systemic immunosuppressive drugs within 2 weeks before the start of study treatment or anticipation of the need for systemic immunosuppressive drugs during study treatment, with the following exceptions: 1) Intranasal, inhaled, topical steroids, or topical steroids (e.g., intra-articular); 2) Physiological doses of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent); 3) Steroid premedication for hypersensitivity (e.g., premedication for CT scan);
• Significant cardiovascular disease, such as cardiac insufficiency above class II (New York Heart Association (NYHA) classification) or left ventricular ejection fraction \< 50%, unstable angina pectoris, myocardial infarction within 1 year, arrhythmia requiring treatment, QTc ≥ 450 ms (male), QTc ≥ 470 ms (female);
• The subject has an active infection or infectious disease, requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection; or has an unexplained fever (body temperature \> 38.5℃) during the screening period or prior to the first dose;
• Interstitial lung disease or non-infectious lung disease (including past medical history and prevalence), uncontrolled systemic diseases, including pulmonary fibrosis, acute lung disease, diabetes (fasting blood glucose (FBG) \> 8.9 mmol/L), hypertension (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 90 mmHg), kidney disease (urine routine showed urine protein ≥ 2 +, or 24 h urine protein quantification \> 1.0g), etc., except for local interstitial pneumonia induced by radiotherapy;
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
• Subjects with a history of other malignancies within the past 5 years, but except for cured cervical carcinoma in situ, squamous cell carcinoma of the skin, basal cell carcinoma of the skin, localized prostate cancer, or other carcinomas in situ with definitive resection;
• Virological screening meets any of the following criteria: hepatitis B HBsAg positive and HBV-DNA ≥ 10\^3 copies/ml; hepatitis C: HCV antibody positive and HCV-RNA positive (results greater than the lower limit of detection of the analytical method);
• Participants may need to be vaccinated during the study or have received a live viral vaccine within 4 weeks prior to enrollment. Seasonal influenza vaccine without live virus is permitted.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (2)

Department of radiotherapy,The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Department of Radiotherapy, Eye & ENT Hospital of Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Recurrence; Neoplasm Metastasis

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiaoshen Wang

  Eye & ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoshen Wang

CONTACT

18917785187; ruijin702@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 2, 2022
• Study Start: January 25, 2022
• Primary Completion: December 25, 2024
• Study Completion (Estimated): December 25, 2026
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)