EUCTR2019-000572-41-BE
Active, not recruiting
Phase 1
An open label phase II study combining Nivolumab and Celecoxibin patients with advanced « cold » solid tumors - NICE-COMBO
ConditionsCancer 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 chemotherapyTherapeutic area: Diseases [C] - Cancer [C04]
DrugsCelecoxib
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- 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
- Sponsor
- Cliniques Universitaires Saint-Luc
- Enrollment
- 68
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Men and women \= 18 years of age.
- •2\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\.
- •3\. Measurable disease as per RECIST 1\.1\.
- •4\. Adequate renal, hepatic and hematologic functions as defined by laboratory parameters within \= 7 days before treatment initiation.
- •\- Platelet count \=100x103/µL
- •\- Leukocyte count \= 3x103/µL
- •\- Hemoglobin \= 9 g/dL
- •\- ASAT and ALAT \= 2xULN
- •\- Serum creatinine \=1\.5xULN
- •\- Total bilirubin \= 1\.5xULN
Exclusion Criteria
- •1\. Active brain metastases or leptomeningeal metastases.
- •2\. Ocular melanoma
- •3\. 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 conditions not expected to
- •recur in the absence of an external trigger are permitted to enroll.
- •4\. Clinically significant cardiovascular disease (including cardiac insufficiency NYHA grade III and IV, unstable angina, arrythmia, myocardial infarction, symptomatic congestive heart failure) in the past 12 months before enrollment
- •5\. Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders or other conditions requiring concurrent medications not allowed during this study
- •6\. Concomitant chemotherapy or radiotherapy for curative intent.
- •7\. Administration of anti\-angiogenic drugs or immunomodulatory agents.
- •8\. Pregnancy or breast\-feeding or planning to become pregnant within 6 months after the end of treatment.
- •9\. Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months after the end of treatment.
Outcomes
Primary Outcomes
Not specified
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