Clinical trial NCT03053661: Immune Response Evaluation to Curative Conventional Therapy
Official title: Immune Response Evaluation to Curative Conventional Therapy of Stage III/IV Head and Neck Squamous Cell Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Head and Neck Squamous Cell Carcinoma
cancer-specific immunity
cancer immunology
cancer-testis antigens
human papilloma virus
immune modulatory cells
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stage III-IVa/b treatment-naive head and neck squamous cell carcinoma patients

Brief summary: The IRECT trial is a non-interventional, prospective clinical trial using modern immune monitoring techniques over the course of the standard of care for HNSCC. The dynamics of host/tumor immune interactions during the conventional standard treatment will be analyzed to find the most promising target antigen and to develop a strategy how and when specific immunotherapy should be added to the current treatment schedule.

The results from this trial will help to understand how state of the art treatment can be complemented using cancer-testis antigen specific vaccines and immune-modulating drugs to improve the outcome of head and neck cancer patients.


Eligibility criteria: Inclusion Criteria:

* newly diagnosed patients with stage III-IVa/b head and neck squamous cell carcinoma
* fit for treatment with curative intent
* conventional primary treatment
* primary surgical treatment
* primary radiotherapeutic treatment
* informed consent
* \>18 years of age
* sufficient contraception

Exclusion Criteria:

* distant metastasis at baseline
* severe concomitant disease compromising curative treatment
* previously diagnosed other malignant diseases
* active immunosuppressive therapy
* known immune defect
* pregnancy
* anemia requiring treatment at study entry (\<9g/dl)

Primary outcomes:
measure: prevalence of spontaneous tumor-specific immunity at baseline
timeFrame: baseline
measure: dynamics of tumor-specific immunity and immune modulatory cells during conventional treatment
timeFrame: 7-12 weeks (treatment phase)
measure: dynamics of tumor-specific immunity and immune modulatory cells during follow up
timeFrame: 12 months after end of treatment
Secondary outcomes:
measure: overall survival at 3 years
timeFrame: baseline - 3 years
measure: progression free survival at 3 years
timeFrame: baseline - 3 years
Other outcomes:
Locations:
Study officials:
References:
citation: von Witzleben A, Fehn A, Grages A, Ezic J, Jeske SS, Puntigam LK, Brunner C, Kraus JM, Kestler HA, Doescher J, Brand M, Theodoraki MN, Ottensmeier CH, Hoffmann TK, Schuler PJ, Laban S. Prospective longitudinal study of immune checkpoint molecule (ICM) expression in immune cell subsets during curative conventional therapy of head and neck squamous cell carcinoma (HNSCC). Int J Cancer. 2021 Apr 15;148(8):2023-2035. doi: 10.1002/ijc.33446. Epub 2020 Dec 30.