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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT03784066
Eligibility Criteria:
Inclusion Criteria:
* Resectable locally advanced oral cavity SCC stage IV
* Newly diagnosed disease
* Age ≥18 years at the time of screening
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
* No active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix
* No prior chemotherapy, radiotherapy or targeted therapy including PD-1, PD-L1 or CTLA-4 antibodies for SCCHN, including durvalumab or tremelimumab
* Availability of blood samples for Translational research
* Negative pregnancy test
* Normal organ function
* No participation in another interventional clinical trial in the preceding 30 days prior to randomization
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
* Body weight \> 30 kg
Exclusion Criteria:
* Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck
* Receipt of other treatments for cancer within 30 days prior to first dose of study treatment
* Previous radiotherapy in the head and neck region
* Previous systemic therapy for SCCHN
* Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned IP.
* History of allogeneic organ transplantation
* Active or prior documented autoimmune or inflammatory
* Uncontrolled intercurrent illness
* Active relevant second malignancy during the last five years
* Mean QT interval corrected for heart rate ≥470 ms
* History of active primary immunodeficiency
* Active infection Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP.
* Female patients of childbearing potential who are pregnant or breast-
* Known allergy or hypersensitivity to IP or any IP excipient
* Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of patient safety or study results
* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP
* Metastatic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03784066
Study Brief:
Protocol Section:
NCT03784066