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

Browse trials for

• Nasopharyngeal Neoplasms 240
• Nasopharyngeal Carcinoma 816

Nasopharyngeal Neoplasms

240 studies on the registry are indexed under Nasopharyngeal Neoplasms; 47 are open to participants now.

This study's planned enrollment of 32 is below the median of 60 across 198 interventional studies indexed under Nasopharyngeal Neoplasms.

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 63 studies on the registry; 16 are open to participants now.

Study arms

• Experimental
  Experimental therapy:OPDIVO (Nivolumab)

  Drug: Opdivo

Interventions

• DrugOpdivo

  Dose of Nivolumab is constant and is 240 mg .All patients will undergo maximum of 12 cycles of investigation product's infusion ( around 6 month of treatment).Each cycle will be done in intervals of 14 day (no less than 12 days after previous infusion and no longer than 42 day/6 weeks after previous infusion).

  Also known as: Nivolumab

Primary outcomes

1. Objective response rate (ORR)

   Percentage of objective responses (partial and complete responses combined /partial response (PR)+ complete response(CR)/ by immune Response Evaluation Criteria in Solid Tumours (iRECIST) response criteria) in MRI (Magnetic Resonance Imaging) after 12 weeks. 1. Partial response - at least a 30% decrease in the sum of the LD(longest diameter) of target lesions, taking as reference the baseline sum LD(longest diameter) 2. Complete response (CR)- disappearance of all target lesions and short dimension of all lymph nodes \< 10 mm

   Time frame: 12 weeks

Secondary outcomes

1. 1.Progression- free survival (PFS) by iRECIST( immune Response Evaluation Criteria in Solid Tumours) criteria- from the beginning of treatment to the progression of disease or death.

   Progression will be evaluated in MRI(Magnetic Resonance Imaging) and defined according to iRECIST(immune Response Evaluation Criteria in Solid Tumours) criteria: * least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the sum must also demonstrate an absolute increase of at least 5 mm. * the appearance of one or more new lesions

   Time frame: 6 month of treatment phase

2. Overall survival (OS) rate- time of total survival

   Time frame: at 6 months (treatment phase), 12 months and 18 months (6th month and 12th month of long term follow up)

3. DCR(disease control rate) per RECIST (Response Evaluation Criteria in Solid Tumours)

   Defined as not meeting the criteria for progression and PR(partial response)

   Time frame: through study completion, an average of 6 months

4. DoR(duration of response) per RECIST (Response Evaluation Criteria in Solid Tumours)

   Measured in MRI(Magnetic Resonance Imaging) from the time when measurement criteria for complete/ partial response are met till time when progression of the disease is documented.

   Time frame: through study completion, an average of 1 year

5. Change in quality of life in EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) (version 3.0) .A high scale score represents a higher response level.

   Time frame: from first infusion to last follow up ( 3 month, 6 month, 9 month,12month follow up)

6. Safety assessment of treatment with Nivolumab measured by excesive toxity

   Time frame: Each visit during treatment phase -12 cycles of investigation product's infusion (around 6 month of treatment).