Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 543 for:    Celecoxib

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03864575
Recruitment Status : Not yet recruiting
First Posted : March 6, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.


Condition or disease Intervention/treatment Phase
Metastatic Cancer Drug: Celecoxib 400 mg Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Simon's two-stage Minimax design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NICE-COMBO: An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combination Group
Celecoxib 400 mg/d Nivolumab 240 mg q2w
Drug: Celecoxib 400 mg
Celecoxib 400 mg/day in combination with nivolumab fixed dose
Other Name: Nivolumab 240 mg q2w




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]

    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


  2. 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 ]
    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.

  3. 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 ]
    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.

  4. Disease control rate (DCR) [ Time Frame: at week 12 from onset of treatment ]
    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.

  5. 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 ]
    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.

  6. Overall survival (OS) [ Time Frame: From date of randomization until the date of death, assessed up to 60 months ]
    defined as the time from the date of first dose of study drug until death, due to any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864575


Contacts
Layout table for location contacts
Contact: Jean-François Baurain, MD,PHD +3227645106 jf.baurain@uclouvain.be

Locations
Layout table for location information
Belgium
Cliniques universitaires Sain-Luc Not yet recruiting
Brussel, Belgium, 1200
Contact: Jean-François Baurain, MD,PHD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Layout table for investigator information
Principal Investigator: Jean-Françoi Baurain, MD,PHD Cliniques universitaires Saint-Luc

Layout table for additonal information
Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03864575     History of Changes
Other Study ID Numbers: LUC-19-002
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Nivolumab
Celecoxib
Additional relevant MeSH terms:
Layout table for MeSH terms
Celecoxib
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action