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

NCT ID: NCT03864575

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2021-06-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination Group

Celecoxib 400 mg/d Nivolumab 240 mg q2w

Group Type: EXPERIMENTAL

Celecoxib 400 mg

Intervention Type: DRUG

Celecoxib 400 mg/day in combination with nivolumab fixed dose

Interventions

Celecoxib 400 mg

Celecoxib 400 mg/day in combination with nivolumab fixed dose

Intervention Type: DRUG

Other Intervention Names

Nivolumab 240 mg q2w

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Françoi Baurain, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

Cliniques universitaires Sain-Luc

Brussels, , Belgium

Countries

Belgium

Central Contacts

Jean-François Baurain, MD,PHD

Role: CONTACT

jf.baurain@uclouvain.be

+3227645106

Facility Contacts

Jean-François Baurain, MD,PHD

Role: primary

Other Identifiers

LUC-19-002

Identifier Type: -

Identifier Source: org_study_id