The primary objective of this study is to evaluate the incidence of high-grade (i.e. Grade 3-4 and Grade 5 of CTCAE v4.0) adverse reactions of interest in patients with metastatic RCC who have progressed during or after receiving at least one prior systemic anti-angiogenic treatment and who are eligible for nivolumab monotherapy.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
730
The dose and schedule of nivolumab in this study will be 3 mg/kg every 2 weeks. Infusion of nivolumab will be performed in 30 minutes (± 5 minutes). Nivolumab will be administered every 2 weeks until death, disease progression, unacceptable toxicity or withdrawal of the informed consent
Centre Francois Baclesse
Caen, France
Centre Georges-Francois Leclerc
Dijon, France
Centre Leon Berard
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Incidence for high-grade (Grade3-4-5) adverse reactions of interest
The primary endpoint of this study is the incidence for high-grade (CTCAE v4.0 Grade 3-4 and Grade 5) adverse reactions of interest (i.e. adverse event related to study treatment). The adverse reactions of interest are: skin, endocrinopathy, gastrointestinal, hepatic, renal, pulmonary, and hypersensitivity adverse events.
Time frame: 5 years
Assessment of Overall Survival (OS) by Follow-up continued
The efficacy data assessed by measuring the OS : OS is defined as the time from first dosing date to the date of death. A patient who has not died will be censored at last known date alive. OS will be followed continuously while patients are on the treatment and every 3 months via in-person or phone contact after patients discontinue the study drug.
Time frame: 5 years
Number of patients with a Best Overall Response (BOR) by RECIST v1.1
Time frame: 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety and tolerability will be measured by the incidence of all adverse events, serious adverse events, deaths and laboratory abnormalities. Adverse event assessments and laboratory tests will be performed at baseline, and continuously throughout the study at the beginning of each subsequent cycle.
Time frame: 5 years
Percentage of patients who received immune modulating concomitant medication
The percentage of patients who received immune modulating concomitant medication (e.g., corticosteroids, infliximab, cyclophosphamide, IVIG, mycophenolate mofetil), collected in a specific form.
Time frame: 5 years
Percentage of patients who received hormonal replacement therapy
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Centre Antoine Lacassagne
Nice, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France
Gustave Roussy Cancer Campus Grand Paris
Villejuif, France
The percentage of patients who received hormonal replacement therapy.
Time frame: 5 years
Median time to resolution of adverse reactions of interest
The median time to onset, median time to resolution (Grade 3-4) of adverse reactions of interest.
Time frame: 5 years
Assessment of quality of life by questionnaire FACT-G
Patient reported outcomes will be assessed by FACT-G
Time frame: 5 years
Assessment of quality of life by questionnaire FKSI-19
Patient reported outcomes will be assessed by FKSI-19.
Time frame: 5 years
Assessment of quality of life by questionnaire EQ-5D
Global health status will be assessed by EQ-5D instrument.
Time frame: 5 years