EUCTR2019-004916-76-IT
Active, not recruiting
Phase 1
A phase II study of nivolumab combined with metformin in pre-treated metastatic renal cell carcinoma (mRCC) patients. - NivoMet
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 sites21 target enrollmentOctober 21, 2020
DrugsOpdivo
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
- Enrollment
- 21
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Willing and able to provide written informed consent
- •2\.Male aged 18 years and above
- •3\.Histological confirmation of RCC with a clear cell component
- •4\.Advanced or metastatic RCC
- •5\.Measurable disease as defined by RECIST1\.1criteria
- •6\.Must have received at least one prior systemic treatment regimen in the advanced or metastatic setting, and must have evidence of progression on or after the last treatment regimen received
- •7\.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- •8\.Adequate bone marrow and chemistry values defined as:
- •a.Hemoglobin \= 9\.0 g/dL independent of transfusion
- •b.Platelet count \=100\.000/µL
Exclusion Criteria
- •1\.Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection
- •2\.Any active known or suspected autoimmune disease
- •3\.Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
- •4\.Uncontrolled adrenal insufficiency
- •5\.Evidence of active pneumonitis during screening, except for pulmonary fibrosis induced by prior thoracic irradiation
- •6\.Dialitic patients
- •7\.Diabetes mellitus
- •8\.Any history of biguanide\-based therapy within 1 year prior to enrollment
- •9\.Current severe, uncontrolled systemic disease
- •10\.Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II\-IV heart disease or cardiac ejection fraction measurement of \< 50% at baseline
Outcomes
Primary Outcomes
Not specified
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