About this trial
Multicentre , non-randomized, prospective clinical trial to assess efficacy of Nivolumab in treatment of nasopharyngeal cancer who progressed during or after platinum-based chemotherapy . Patients disqualified from radical therapy . The total number of patients was estimated for 32.
Eligibility criteria
Qualifiers
Age > 18 years old
Histological or cytological documentation of squamous cell carcinoma.
Primary tumor location in nasopharynx
Previous, documented failure on platinum-based chemotherapy or progression of the disease during platinum-based chemotherapy
Disqualifiers
Known active central nervous system metastases.
Presence of renal insufficiency defined as eGFR(estimated glomerular filtration rate) < 30 ml/min/m2
Presence of liver disfunction, defined as level of AST(aspartate aminotransferase) and /or ALT(alanine aminotransferase) > 2,5 x ULN(upper limits of normal) (> 5 x ULN in patients with documented liver metastases); total bilirubin > 1,5 xULN ( bilirubin > 1,5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%) or albumin < 2,5 g/dL
Abnormalities in blood count such as: hemoglobin < 9 g/dl, platelets < 100 x 109 /L, Absolute Neutrophil Count (ANC) <1,0 x 109 /L
Trial design
Treatments tested in this trial
- Opdivo