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| Name | Class |
|---|---|
| KCRI | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental therapy:OPDIVO (Nivolumab) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opdivo | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego Szpitala Klinicznego w Białymstoku | Recruiting | Bialystok | Poland |
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| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| 6 month of treatment phase |
| Overall survival (OS) rate- time of total survival | at 6 months (treatment phase), 12 months and 18 months (6th month and 12th month of long term follow up) |
| DCR(disease control rate) per RECIST (Response Evaluation Criteria in Solid Tumours) | Defined as not meeting the criteria for progression and PR(partial response) | through study completion, an average of 6 months |
| 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. | through study completion, an average of 1 year |
| 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. | from first infusion to last follow up ( 3 month, 6 month, 9 month,12month follow up) |
| Safety assessment of treatment with Nivolumab measured by excesive toxity | Each visit during treatment phase -12 cycles of investigation product's infusion (around 6 month of treatment). |
| Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego | Recruiting | Gdansk | Poland |
|
| Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach | Recruiting | Gliwice | 44-101 | Poland |
|
| Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii | Recruiting | Kielce | Poland |
|
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |