BridgeMD
New treatment option for Head and Neck Neoplasms
Official title Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN
ClinicalTrials.gov ID: NCT05260671
What this study is testing
What is Penpulimab combined with cetuximab?
Penpulimab combined with cetuximab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for head and neck neoplasms.
Also referred to as AK105+Erbitux.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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;
You likely can't join if
- Received systemic chemotherapy, but excluding chemotherapy for locally advanced disease as a part of multimodal treatment. Note: Chemotherapy for...
- 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...
- 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...
- Presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which may present with clinical symptoms, cerebral edema...
See the full eligibility criteria
- 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 ×...
- 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...
- The people voluntarily join the study, sign the ICF, have good compliance, and cooperate in the follow-up
- 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...
- 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...
- 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...
- 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...
- 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...
- 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℃)...
- 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...
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- people 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...
- 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...
- 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.
- Patients with other concomitant diseases that seriously jeopardize the patient's safety or affect the patient's completion of the study, as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.