Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT02383966
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02383966
Study Brief:
Protocol Section:
NCT02383966