This study is a multicentric phase II open-label trial consisting of 6 cycles Nivolumab (2 weeks interval) followed by a PET-CT scan. The treatment will be allocated according to PET and CT scan responses. : * In case of CMR according to Lugano Classification (Cheson et al.2014, PET-CT based response), patients will receive 18 additional cycles of Nivolumab, according to CT-based response at Cycle 12. * In case of Partial Metabolic Response (PMR) or No Metabolic Response(NMR), according to Lugano Classification (Cheson et al.2014, PET-CT based response) patients will receive 12 to 18 cycles of Nivolumab combined with Vinblastin according to CT-based response at Cycle 12. * In case of progressive disease, according to Lugano Classification (Cheson et al.2014, PET-CT scan based response) patients will be considered in treatment failure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
240 mg
6mg/m²
ZNA Stuivenberg
Antwerp, Belgium
Az Sint Jan
Bruges, Belgium
Clinique Universitaire Saint LUC
Brussels, Belgium
Institut Jules Bordet
Brussels, Belgium
Hopital Jolimont
Haine-Saint-Paul, Belgium
Az Groeninge
Kortrijk, Belgium
Complete Metabolic Response (CMR) rate (Deauville scale 1-3) at the end of treatment
by the Lugano classification 2014
Time frame: 12 months
Quantity of drug taken
Time frame: 12 months
Number of Serious Adverse Event
Time frame: 12 months
Progression-free survival (PFS)
Time frame: 5 years
Event-free survival (EFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Complete Metabolic Response (CMR) rate
by the Lugano classification 2014 at the end of induction treatment
Time frame: 3 months
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CHU de Liege
Liège, Belgium
CHU Dinant Godinne
Yvoir, Belgium
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Yvoir, Belgium
CHU d'Amiens
Amiens, France
...and 41 more locations