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:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT03771820
Eligibility Criteria:
Inclusion Criteria:
* Be willing and able to provide written informed consent for the trial.
* Males or females aged ≥18 years at screening.
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Have histologically- or cytologically-confirmed HNSCC.
* Have recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies.
* Having prior platinum failure.
Exclusion Criteria:
* Subjects with carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary origination, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, nonsquamous histologies.
* Have disease that is suitable for locoregional treatment administered with curative intent or refuses curative intent.
* Have no more than 15% body weight loss due to the underlying condition in the last 3 months from signing of informed consent in Part 1 of the study and from randomization in to Part 2.
* Are currently participating in or have participated in a study of an investigational agent or are using an investigational device within 4 weeks prior to the first dose of trial treatment.
* Were previously treated with 3 or more lines of systemic therapies administered for recurrent and/or metastatic disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03771820
Study Brief:
Protocol Section:
NCT03771820