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.
Single group
Nivolumab (240 mg)
DrugNivolumab at day 1 and day 15 prior to the curative standard of care surgery.
Frequency of response
Frequency of tumor response measured as Objective Response Rate (ORR) based on the standard RECIST v1.1 criteria, assessed using radiographic images.
Frequency of pathological response
Tumour pathological response, defined as percentage residual tumour cells after treatment, measured as Pathologic Complete Response, pCR (no residual tumour cells in tumor bed or lymph nodes), Major Pathological Response, MPR (≤10% residual viable tumour), Pathological Partial Response, pPR (≤50% residual viable tumour).
Frequency of volumetric tumour response
Volumetric tumour response, measured by radiographic images and/or physical measurements and assessments.
Incidence of treatment-related Adverse events (TRAEs)
Incidence of treatment related adverse events classified according to the definitions in NCI CTCAE version 5.0.
Incidence of Serious adverse events (SAE)
Incidence of serious adverse events
Change from baseline in hematology parameters
Change from baseline in white blood cells (WBC), white blood cell differentiation, absolute neutrophil count (ANC), thrombocytes/platelets, erythrocytes (haematocrit), (B)Erc-MCH, (B)Erc-MCV, haemoglobin (Hb).
Change from baseline in clinical chemistry parameters
Change from baseline in Electrolyte status: sodium (Na), potassium (K), calcium (Ca), creatinine, Liver status: albumin, bilirubin, alkaline phosphatase (ALP), alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), lactate dehydrogenase (LD), gamma-glutamyl transferase (GGT), Amylase, glucose, and c-reactive protein (CRP).
Correlation and evaluation of various biomarkers to nivolumab treatment response, prognosis and survival
Correlation of different biological markers, immune cell populations, gene expression and protein signatures, analyzed from sequential tumor and lymph node biopsies and blood, with treatment efficacy, prognosis and safety.
Click on the lead sponsor to view all of their trials.
Prof. Lars Olaf Cardell
Lead sponsor
Karolinska University Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
