Metastatic CancerPhase 2NICE-COMBONCT03864575
An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors
A Phase 2 study testing Celecoxib 400 mg in people with Metastatic Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Celecoxib 400 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Aug 2019to 15 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Cancer types with an indication of treatment with anti-PD1 antibodies such as
- Melanoma non BRAF mutated in first line of treatment
- Melanoma BRAF mutated in first or second line of treatment
- Lung cancer (NSCLC) in second line of treatment
- Renal cell Cancer (RCC) in second line of treatment
- Head and Neck squamous carcinoma (HNSC) after platinum salt based chemotherapy
- Bladder cancer after platinum salt based chemotherapy
Who cannot join
- Active brain metastases or leptomeningeal metastases.
- Ocular melanoma.
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic treatment, or other autoimmune condition not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects must also meet other study criteria including exclusions for medical history, positive Hep B/C, HIV, and pregnancy tests, and other laboratory criteria.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Sain-Luc
Brussels, 1200
Jean-François Baurain, MD,PHD
About this study
Official title: NICE-COMBO: An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors
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.
- Conditions
- Metastatic Cancer
- Being tested
- Celecoxib 400 mg
- Keywords
- Nivolumab, Celecoxib
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celecoxib 400 mgDrug
Also called Nivolumab 240 mg q2w
Celecoxib 400 mg/day in combination with nivolumab fixed dose
| Study group | Role | What they receive |
|---|---|---|
| Combination Group | Experimental | Celecoxib 400 mg/d Nivolumab 240 mg q2w Receives: Drug: Celecoxib 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
To evaluate the objective response rate (ORR) of Celecoxib in combination with anti-PD1 antibodies
Measured: at week 12 from onset of treatment
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From date of randomization until the date of death, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start15 Aug 2019 (estimated)
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Simon's two-stage Minimax design
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Françoi Baurain, MD,PHD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864575
- Sponsor's protocol ID
- LUC-19-002
- Acronym
- NICE-COMBO
- Status last verified
- Jul 2019
- First submitted
- 28 Feb 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NICE-COMBO: An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors
- ClinicalTrials.gov ID
- NCT03864575
- Acronym / sponsor ID
- NICE-COMBO / LUC-19-002
- Conditions
- Metastatic Cancer
- Keywords
- Nivolumab, Celecoxib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Aug 2019 (estimated)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simon's two-stage Minimax design
| Arm | Type | Receives |
|---|---|---|
| Combination Group | Experimental | Drug: Celecoxib 400 mgCelecoxib 400 mg/d Nivolumab 240 mg q2w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (4 listed)
- Active brain metastases or leptomeningeal metastases.
- Ocular melanoma.
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic treatment, or other autoimmune condition not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects must also meet other study criteria including exclusions for medical history, positive Hep B/C, HIV, and pregnancy tests, and other laboratory criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib 400 mgAlso: Nivolumab 240 mg q2wCelecoxib 400 mg/day in combination with nivolumab fixed dose | Drug | Combination Group |
Primary outcome
objective response rate
Time frame: at week 12 from onset of treatment
To evaluate the objective response rate (ORR) of Celecoxib in combination with anti-PD1 antibodies
6 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: from first dose to day 28 post last dose
Efficacy - Duration of response (DOR)
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)
Time frame: From onset of treatment to response of cancer through study completion, an average of 12 months is expected
Disease control rate (DCR)
Time frame: at week 12 from onset of treatment
Progression-free survival (PFS)
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)
Time frame: From date of randomization until the date of death, assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Françoi Baurain, MD,PHD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib 400 mg in people with Metastatic Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Baurain, MD,PHD (+3227645106, jf.baurain@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: at week 12 from onset of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.