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

NCT03864575 | Unknown Phase 2 DMC

• 1 other identifier: LUC-19-002
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer

Keywords

Nivolumab; Celecoxib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  from first dose to day 28 post last dose

• Efficacy - Duration of response (DOR)

  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)

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

• Disease control rate (DCR)

  at week 12 from onset of treatment

• Progression-free survival (PFS)

  From date of randomization until the date of first documented progression or date of death, whichever comes first, assessed up to 60 months

Study Arms (1)

Combination Group

EXPERIMENTAL

Celecoxib 400 mg/d Nivolumab 240 mg q2w

Drug: Celecoxib 400 mg

Interventions

Celecoxib 400 mg DRUG

Celecoxib 400 mg/day in combination with nivolumab fixed dose

Also known as: Nivolumab 240 mg q2w

Combination Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Sain-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Celecoxib; Nivolumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jean-Françoi Baurain, MD,PHD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-François Baurain, MD,PHD

CONTACT

+3227645106; jf.baurain@uclouvain.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Simon's two-stage Minimax design

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 6, 2019
• Study Start: August 15, 2019
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)