This is an open-label study to evaluate the safety and the anti-tumor activity of the combination of nivolumab and celecoxib. The total numbers of participants to be enrolled will be up to 68 participants, depending on the investigated dose of celecoxib during the safety run-in phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Celecoxib 400 mg/day in combination with nivolumab fixed dose
Cliniques universitaires Sain-Luc
Brussels, Belgium
objective response rate
To evaluate the objective response rate (ORR) of Celecoxib in combination with anti-PD1 antibodies
Time frame: at week 12 from onset of treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
All the patients that will receive at least one dose of nivolumab and celecoxib are assess for toxicity endpoint. All adverse events will be recorded and graded based on the CTCAE v4.0 scale. antibodies
Time frame: from first dose to day 28 post last dose
Efficacy - Duration of response (DOR)
defined as the time from earliest date of CR or PR (as determined by investigator assessment of radiographic disease burden per RECIST v1.1) until the earliest date of disease progression or death, due to any cause, if occurring sooner than disease progression.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Efficacy - Time to response (TTR)
defined as the time from the date of first dose of study drug until the time of the earliest date of CR or PR (as determined by investigator assessment of radiographic disease burden per RECIST v1.1.
Time frame: From onset of treatment to response of cancer through study completion, an average of 12 months is expected
Disease control rate (DCR)
defined as the percentage of subjects having CR, PR, or stable disease (SD) for at least 8 weeks, as determined by investigator assessment of radiographic disease as per RECIST v1.1.
Time frame: at week 12 from onset of treatment
Progression-free survival (PFS)
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defined as the time from the date of first dose of study drug until the earliest date of disease progression (as determined by investigator assessment of radiographic disease burden per RECIST v1.1), or death due to any cause, if occurring sooner than progression.
Time frame: From date of randomization until the date of first documented progression or date of death, whichever comes first, assessed up to 60 months
Overall survival (OS)
defined as the time from the date of first dose of study drug until death, due to any cause.
Time frame: From date of randomization until the date of death, assessed up to 60 months