Clinical trial NCT03864575: An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors
Official title: NICE-COMBO: An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Cancer
Keywords: Nivolumab
Celecoxib
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Simon's two-stage Minimax design
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: objective response rate
timeFrame: at week 12 from onset of treatment
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: from first dose to day 28 post last dose
measure: Efficacy - Duration of response (DOR)
timeFrame: 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
measure: Efficacy - Time to response (TTR)
timeFrame: From onset of treatment to response of cancer through study completion, an average of 12 months is expected
measure: Disease control rate (DCR)
timeFrame: at week 12 from onset of treatment
measure: Progression-free survival (PFS)
timeFrame: From date of randomization until the date of first documented progression or date of death, whichever comes first, assessed up to 60 months
measure: Overall survival (OS)
timeFrame: From date of randomization until the date of death, assessed up to 60 months
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques universitaires Sain-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Jean-Françoi Baurain, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: