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

Primary Purpose

Metastatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Celecoxib 400 mg

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring Nivolumab, Celecoxib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cliniques universitaires Sain-Luc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination Group

Arm Description

Celecoxib 400 mg/d Nivolumab 240 mg q2w

Outcomes

Primary Outcome Measures

objective response rate

To evaluate the objective response rate (ORR) of Celecoxib in combination with anti-PD1 antibodies

Secondary Outcome Measures

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

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.

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.

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.

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.

Overall survival (OS)

defined as the time from the date of first dose of study drug until death, due to any cause.

Full Information

NCT ID

NCT03864575

First Posted

February 28, 2019

Last Updated

July 11, 2019

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT03864575

Brief Title

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

Acronym

NICE-COMBO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 15, 2019 (Anticipated)

Primary Completion Date

June 15, 2021 (Anticipated)

Study Completion Date

June 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Cancer

Keywords

Nivolumab, Celecoxib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Simon's two-stage Minimax design

Masking

None (Open Label)

Allocation

N/A

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combination Group

Arm Type

Experimental

Arm Description

Celecoxib 400 mg/d Nivolumab 240 mg q2w

Intervention Type

Drug

Intervention Name(s)

Celecoxib 400 mg

Other Intervention Name(s)

Nivolumab 240 mg q2w

Intervention Description

Celecoxib 400 mg/day in combination with nivolumab fixed dose

Primary Outcome Measure Information:

Title

objective response rate

Description

To evaluate the objective response rate (ORR) of Celecoxib in combination with anti-PD1 antibodies

Time Frame

at week 12 from onset of treatment

Secondary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Description

Time Frame

from first dose to day 28 post last dose

Title

Efficacy - Duration of response (DOR)

Description

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

Title

Efficacy - Time to response (TTR)

Description

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.

Time Frame

From onset of treatment to response of cancer through study completion, an average of 12 months is expected

Title

Disease control rate (DCR)

Description

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.

Time Frame

at week 12 from onset of treatment

Title

Progression-free survival (PFS)

Description

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

Title

Overall survival (OS)

Description

defined as the time from the date of first dose of study drug until death, due to any cause.

Time Frame

From date of randomization until the date of death, assessed up to 60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean-François Baurain, MD,PHD

Phone

+3227645106

jf.baurain@uclouvain.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Françoi Baurain, MD,PHD

Organizational Affiliation

Cliniques universitaires Saint-Luc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cliniques universitaires Sain-Luc

City

Brussel

ZIP/Postal Code

1200

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-François Baurain, MD,PHD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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