Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaria Sklodowska-Curie National Research Institute of Oncology

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

Treatment groups

32 Participants
are divided into 1 treatment group