Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Group | Experimental | Celecoxib 400 mg/d Nivolumab 240 mg q2w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib 400 mg | Drug | Celecoxib 400 mg/day in combination with nivolumab fixed dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | To evaluate the objective response rate (ORR) of Celecoxib in combination with anti-PD1 antibodies | at week 12 from onset of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from first dose to day 28 post last dose |
Not provided
Inclusion Criteria:
Men and women ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Measurable disease as per RECIST 1.1.
Adequate renal, hepatic and hematologic functions as defined by laboratory parameters within ≤ 7 days before treatment initiation.
Metastases biopsiable on two occasions
Recently acquired (within 90 days prior to treatment) tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. In order to include only IDO1 positive (≥5% expression of tumor cells) and non T-cell infiltrated tumors (<1% T cells infiltrating the tumor bed)
Cancer types with an indication of treatment with anti-PD1 antibodies such as
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-François Baurain, MD,PHD | Contact | +3227645106 | jf.baurain@uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Françoi Baurain, MD,PHD | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Sain-Luc | Brussels | 1200 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Simon's two-stage Minimax design
Not provided
Not provided
Not provided
Not provided
| 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. |
| 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. | 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. | at week 12 from onset of treatment |
| Progression-free survival (PFS) | 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. | 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. | From date of randomization until the date of death, assessed up to 60 months |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |