Klinische Studie
Induction chemotherapy with Docetaxel and Cisplatin (TP) followed by radiation compared to additional PD-1 inhibition in CPS ≥1 advanced laryngeal and hypopharyngeal cancer suitable for laryngectomy selected after short induction early response evaluation(ELOS)European Larynx Organ Preservation Study (ELOS
Krankheitsentität(en)
Kopf-Hals Bereich
StudientypInterventionsstudiePhase II
StudientypInterventionsstudiePhase II
Wesentliche Einschlusskriterien1. Male and female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of squamous cell carcinoma (SCC) of the larynx or hypopharynx according to the decision of the multidisciplinary tumor board suitable for laryngectomy can be enrolled in this study.
2. Stage III, IVA or IVB, whenever clear resection margins R0 >5 mm can be achieved and no radiologic signs of extranodal extension of neck nodes is present.
3. Have provided newly obtained excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
4. PD-L1-expression within the tumor biopsy, CPS ≥1.
Wesentliche Ausschlusskriterien1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to receiving the first dose of study medication (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory receptor on T or NK cells (e.g., CTLA-4, OX-40, CD137).
3. Has received prior systemic anti-cancer therapy including investigational agents.
4. Has received prior radiotherapy.
5. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
Statusrekrutierend
Ansprechpartner & KontaktUniversitätsklinikum RegensburgStrahlentherapieStudienzentrale0941 9447620studien.stt(at)ukr.de