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

July 11, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussel, Belgium, 1200
        • Cliniques Universitaires Sain-Luc
        • Contact:
          • Jean-François Baurain, MD,PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Nivolumab 240 mg q2w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at week 12 from onset of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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)
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.
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
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)
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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Jean-Françoi Baurain, MD,PHD, Cliniques universitaires Saint-Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 15, 2019

Primary Completion (Anticipated)

June 15, 2021

Study Completion (Anticipated)

June 15, 2021

Study Registration Dates

First Submitted

February 28, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUC-19-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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