This is a Phase II, single-centre, non-randomized, single-arm clinical trial to investigate the efficacy and safety of neoadjuvant nivolumab therapy in adult participants with resectable, locoregionally advanced Oral Squamous Cell Carcinoma (OSCC) tumors. Identification of predictive molecular biomarkers of tumor response to treatment will also be performed.
The subject is willing to participate and has given their written and dated consent to participate in the trial.
Naïve to immunotherapy.
Primary histologically or cytologically confirmed Oral Squamous Cell Carcinoma classified according to the ICD-10 classification.
Stage T2-4 N0-3 M0.
Distant metastases (pathologically proven, radiologic or clinical evidence of distant metastatic disease). This includes all diseases below the clavicles, as well as disease metastatic to the bone, brain, or in the spinal canal.
Active malignancy requiring concurrent treatment or history of another primary malignancy.
History of radio- and/or chemotherapy.
Pregnant, breastfeeding, planning pregnancy or refusal to use highly effective contraception method during the treatment period and for at least 5 months after the last dose.
Prof. Lars Olaf Cardell
Lead sponsor
Karolinska University Hospital
Sponsor institution