This study evaluates the addition of nivolumab to gemcitabine, oxaliplatin plus rituximab in case of B-cell lymphoma
International, multicentre, randomised, open-label, treatment optimisation study, preceded by safety run-in phases conducted for B-cell and T-cell lymphoma separately.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
348
eight cycles of nivolumab (240 mg flatdose) plus (R)-GemOx in 2-wk intervals followed by additional 9 infusions of Nivolumab (480 mg flatdose) in 4-wk intervals as consolidation or up to progression or unacceptable toxicity, whatever occurs first
eight cycles of R-GemOx in 2-wk intervals
eight cycles of (R)-GemOx in 2-wk intervals
PFS
Progression free survival
Time frame: 1 year
CR rate
complete response rate
Time frame: 4-6 weeks after cycle 8 (each cycle is 14 days)
PR rate
partial response rate
Time frame: 4-6 weeks after cycle 8 (each cycle is 14 days)
ORR rate
overall response rate
Time frame: 4-6 weeks after cycle 8 (each cycle is 14 days)
Duration of response
Duration of response
Time frame: up to 2 years after inclusion of last patient
Primary Progression rate
Rate of Primary progression
Time frame: up to 2 years after inclusion of last patient
Treatment related deaths rate
Rate of Treatment related deaths
Time frame: up to 2 years after inclusion of last patient
Relapse rate
Rate of relapses
Time frame: up to 2 years after inclusion of last patient
EFS
Event free survival
Time frame: up to 2 years after inclusion of last patient
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eight cycles of (R)-GemOx in 2-wk intervals
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Innsbruck University Hospital
Innsbruck, Austria
Kepler Universitätsklinikum GmbH- Med. Campus III
Linz, Austria
Ordensklinikum Linz - Elisabethinen
Linz, Austria
Ordensklinikum Linz - Krankenhaus der Barmherzigen Schwestern Linz
Linz, Austria
Paracelsus Medical University Salzburg
Salzburg, Austria
Universitätsklinik für Innere Medizin I, AKH Wien
Vienna, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Austria
INSTITUT JULES BORDET -Hematology
Brussels, Belgium
UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Hematology
Brussels, Belgium
...and 67 more locations
OS
Overall survival
Time frame: up to 2 years after inclusion of last patient
Toxicities: rates and grades of adverse events
Toxicity: Rates and grades of toxicities will be determined according to CTC-v4.03
Time frame: up to 2 years after inclusion of last patient
Protocol adherence according to number of given chemotherapy cycles
Protocol adherence will be determined according to number of chemotherapy cycles
Time frame: up to 2 years after inclusion of last patient
Protocol adherence according to duration of given chemotherapy cycles
Protocol adherence will be determined according to duration of chemotherapy cycles
Time frame: up to 2 years after inclusion of last patient
Protocol adherence according to cumulative dose of immunochemotherapy given
Protocol adherence will be determined according to cumulative dose of immunochemotherapy given
Time frame: up to 2 years after inclusion of last patient
Protocol adherence according to relative dose of immunochemotherapy given
Protocol adherence will be determined according to relative dose of immunochemotherapy given
Time frame: up to 2 years after inclusion of last patient
QoL
Quality of Life (QoL) will be assessed by the EQ-5D-5L questionnaire
Time frame: up to 1 year after inclusion of last patient
Biological Parameters according to PD-L1 expression alterations
Outcome assessment of response according to PD-L1 expression alterations
Time frame: up to 2 years after inclusion of last patient
Biological Parameters according to PD-1 expression
Outcome assessment of response according to PD-1 expression
Time frame: up to 2 years after inclusion of last patient
Biological Parameters according to cell of origin
Outcome assessment of response according to cell of origin
Time frame: up to 2 years after inclusion of last patient
Biological Parameters according to 9p24.1 alterations
Outcome assessment of response according to 9p24.1 alterations
Time frame: up to 2 years after inclusion of last patient