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

Metastatic Cancer Clinical Trial

— NICE-COMBO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03864575
• Other study ID #: LUC-19-002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 15, 2019
• Est. completion date: June 15, 2021

Study information

• Verified date: July 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Jean-François Baurain, MD,PHD
• Phone: +3227645106
• Email: jf.baurain[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• Celecoxib 400 mg
Celecoxib 400 mg/day in combination with nivolumab fixed dose

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Sain-Luc	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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