CETUXIMAB for Head and neck squamous cell carcinoma | Head and neck cancer

Inclusion criteria

• {"criterion_text":"- Adults >= 18 years old"}
• {"criterion_text":"- Histologically confirmed HNSCC from any primary site; nasopharyngeal carcinoma and paranasal sinus, will be included; squamous cell carcinoma of unknown primary, clearly related to the head and neck, will be included"}
• {"criterion_text":"- Recurrent/metastatic disease, fulfilling at least one of the criteria defined below: a) Incurable disease as assessed by surgical or radiation oncology b) Metastatic (M1) disease c) Persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity; patients who decline radical surgery are eligible"}
• {"criterion_text":"- For patients with oropharyngeal primary site or unknown primary site only: tumoral human papillomavirus (HPV) status must be negative, as established; acceptable standards include p16 immunohistochemistry (where a tumor is classified as p16-positive when showing diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells) and/or assessment of HPV deoxyribonucleic acid (DNA) For patients with nasopharyngeal cancer only or unknown primary site only: tumoral Epstein- Barr Virus (EBV) status must be negative."}

Exclusion criteria

• {"criterion_text":"- History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agen"}
• {"criterion_text":"- Prior treatment with a hepatocyte growth factor (HGF)/cMet inhibitor such as rilotumumab, crizotinib, MetMAb, or ARQ197"}
• {"criterion_text":"- Uncontrolled central nervous system (CNS) metastases, including leptomeningeal metastases, are not allowed; subjects with previously treated brain metastases will be allowed if the brain metastases have been stable without steroid treatment for at least 2 weeks (radiotherapy or surgery)"}
• {"criterion_text":"- Failure to recover to grade 1 or baseline from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, immunotherapy, and/or experimental therapy, with the exception of: alopecia, grade =< 2 peripheral neuropathy, grade =< 2 cetuximab-related rash or other skin changes, hypomagnesemia (acceptable values detailed below), hypokalemia (acceptable values detailed below), and the acceptable hematologic values summarized above; a washout period of 3 weeks from any prior cytotoxic chemotherapy, targeted therapy, immunotherapy or investigational drug is required"}
• {"criterion_text":"- Previous treatment with cetuximab for RM disease. Use of cetuximab is allowed if given concurrently with radiation"}
• {"criterion_text":"- Significant pulmonary disease, including pulmonary hypertension or interstitial pneumonitis"}
• {"criterion_text":"- Peripheral edema >= grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0"}

Primary endpoints

• {"endpoint_text":"- Objective response (OR, confirmed complete response [CR] or partial response [PR]) determined according to RECIST Version 1.1 assessed by the Investigators","definition_or_measurement_approach":"Determined according to RECIST Version 1.1 assessed by the Investigators"}

Italy

Earliest CTIS Part Ii Submission Date

09-10-2024

Latest Decision Or Authorization Date

01-12-2025

Processing Time Days

418

Number Of Sites

11

Number Of Participants

30

Primary sponsor

Full Name

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy