Status:
UNKNOWN
An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 partici...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2021
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03864575
Start Date
August 15 2019
End Date
June 15 2021
Last Update
July 12 2019
Active Locations (1)
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1
Cliniques universitaires Sain-Luc
Brussels, Belgium, 1200