Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced Or Metastatic Clear-cell RCC
- Conditions
- Advanced or metastatic (medically or surgically unresectable) clear-cell Renal Cell CarcinomaMedDRA version: 20.0 Level: PT Classification code 10038414 Term: Renal cell carcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10067946 Term: Renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-005132-26-FI
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 975
1.Men & women = 18 years of age
2.Histologic confirmation of RCC with clear-cell component
3.Advanced/metastatic RCC
4.Measurable disease per RECIST 1.1 criteria
5.Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
6.No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
7.Karnofsky Performance Score = 70%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 585
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 390
1.Any CNS metastases or history of CNS metastases
2.Prior therapy with an mTOR inhibitor
3.Any active known or suspected autoimmune disease.
4.Uncontrolled adrenal insufficiency
5.Active chronic liver disease
6.Prior malignancy active within past 3 years, except for locally curable cancers
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy.;<br> Secondary Objective: 1.Objective response rate<br> 2.Progression-free survival<br> 3.Duration of objective response<br> 4.Duration of OS in PD-L1 positive vs negative subgroups<br> 5.Overall safety & tolerability <br> 6.Disease related symptom progression rate<br> ;Primary end point(s): The primary endpoint is overall survival.;Timepoint(s) of evaluation of this end point: Overall survival will be followed at every clinic visit (every 2-4 weeks) while on treatment and then every 3 months.
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 1.Objective response rate<br> 2.Progression-free survival<br> 3.Duration of objective response<br> 4.Duration of OS in PD-L1 positive vs negative subgroups<br> 5.Overall safety & tolerability <br> 6.Disease related symptom progression rate<br> ;<br> Timepoint(s) of evaluation of this end point: 1.Disease assessments Q 8 wks after randomization for 12 months then Q 12 wks until progression of disease<br> 2.See above<br> 3.See above<br> 4.At time of OS analysis (see #38 for timeframe of collection of OS)<br> 5.Continuously throughout study treatment and up to 100 days from last dose<br> 6.Baseline, Day 1 of each cycle (starting with cycle 2), then at first 2 follow-up visits<br>