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Nivolumab

Celecoxib

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Celecoxib 400 mg/day in combination with nivolumab fixed dose

Celecoxib 400 mg

Jean-François Baurain, MD,PHD

Jean-Françoi Baurain, MD,PHD

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.

An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors

NICE-COMBO: An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors

To evaluate the objective response rate (ORR) of Celecoxib in combination with anti-PD1 antibodies

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

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.

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.

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.

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.

defined as the time from the date of first dose of study drug until death, due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors	NCT03864575	Metastatic Canc...	Celecoxib 400 m...	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors	NCT03864575	Metastatic Canc...	Celecoxib 400 m...	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors	NCT03864575	Metastatic Canc...	Celecoxib 400 m...	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Spots Global Cancer Trial Database for celecoxib 400 mg