A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
Launched by MERCK KGAA, DARMSTADT, GERMANY · Mar 2, 2010
Trial Information
Current as of August 11, 2025
Completed
Keywords
ClinConnect Summary
Cetuximab is an immunoglobulin G1 (IgG1) monoclonal antibody that enhances the effects of some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping toxicities with these approaches. This prospective, observational, non-interventional and multi-centric post marketing surveillance study is being conducted to collect safety information from subjects with locally advanced or recurrent/metastatic SCCHN treated with cetuximab based on the locally approved label. Study plans to enroll 200 to 300 subjects, who are eligible for cetuximab treatment according to the indicat...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Histologically proven Stage 3-4 locally advanced SCCHN (oropharynx, hypopharynx, larynx) or recurrent and/or metastatic SCCHN
- • Age greater than or equal to 18 years
- • Signed informed consent
- Exclusion Criteria:
- • Subjects with known severe (Grade 3 or 4; National Cancer Institute Common Toxicity Criteria Version 4.03) hypersensitivity reactions to Cetuximab
- • Subjects with contraindications for concomitantly used chemotherapeutic agents or radiation therapy, identified before initiation of cetuximab combination treatment
About Merck Kgaa, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, is a leading global science and technology company, specializing in healthcare, life sciences, and performance materials. With a rich history dating back to 1668, Merck KGaA is committed to advancing innovative solutions that improve the quality of life for patients and drive scientific discovery. The company invests significantly in research and development to bring cutting-edge therapies to market, focusing on areas such as oncology, immunology, and neurology. As a dedicated clinical trial sponsor, Merck KGaA collaborates with healthcare professionals and institutions worldwide to conduct rigorous trials that ensure the safety and efficacy of its products, ultimately aiming to enhance patient outcomes and foster global health advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Liouying, Tainan County, Taiwan
Patients applied
Trial Officials
Chao-Jung Tsao, Dr.
Principal Investigator
Liouying Chi-Mei Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials