Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Progresses During or After Prior Systemic Anti-angiogenic Regimen
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 450
Summary
- Conditions
- Metastatic Renal Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The present study will be carried out in patients suffering from refractory metastatic Renal Cell Carcinoma. The overall study population consists of 450 adult patients. In France, 10600 patients were diagnosed with kidney cancer in 2010. At the time of their diagnosis, approximately 30% of patients...
The present study will be carried out in patients suffering from refractory metastatic Renal Cell Carcinoma. The overall study population consists of 450 adult patients. In France, 10600 patients were diagnosed with kidney cancer in 2010. At the time of their diagnosis, approximately 30% of patients present with metastatic disease, with 90 to 95% of that metastatic disease being of the clear-cell histology. The present study is a multicenter, open-label, non-controlled, phase II safety study in patients who are suffering from metastatic Renal Cell Carcinoma and who have progressed during or after one prior systemic anti-angiogenic treatment. Patients intolerant to prior systemic anti-angiogenic treatment can also be eligible. The dose and schedule of nivolumab in this study will be 3 mg/kg every 2 weeks. Nivolumab will be administered every 2 weeks until death, disease progression, unacceptable toxicity or withdrawal of the informed consent. 450 patients should be included over a period of 1 year
Tracking Information
- NCT #
- NCT03013335
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Bernard ESCUDIER Gustave Roussy, Cancer Campus, Grand Paris Principal Investigator: Laurence ALBIGES Gustave Roussy, Cancer Campus, Grand Paris