Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This trial aimed to assess efficacy and safety of cetuximab when given in combination with chemotherapy compared with chemotherapy alone in Chinese participants with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Carboplatin; Cetuximab; Cisplatin; Fluorouracil

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of SCCHN

• Recurrent and/or metastatic SCCHN, not suitable for local-regional treatment

• Presence of at least 1 measurable lesion according to RECIST Version 1.1

• Signed written informed consent before any trial-related activities are carried out

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

• Prior systemic chemotherapy, except if given as part of multimodal treatment for locally advanced disease, that was completed within 6 months before randomization

• Surgery (excluding prior biopsy for diagnosis) or irradiation within 4 weeks before trial entry

• Previous treatment with monoclonal antibody or signal transduction inhibitors targeting epidermal growth factor receptor

• Nasopharyngeal carcinoma

• Known central nervous system metastasis and/or leptomeningeal disease

• Medical or psychological condition that would not permit the participant to complete the trial or sign informed consent

• Legal incapacity or limited legal capacity

• Other protocol-defined exclusion criteria could apply