A Phase 2 Dose-Ranging Study of BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma
- Conditions
- Advanced/Metastatic renal cell carcinoma with a clear cell componentMedDRA version: 18.0Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10038410Term: Renal cell carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002957-67-FI
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 181
• Histologic confirmation of RCC with a clear cell component.
• Previous treatment with at least one anti-angiogenic agent
• Progressed within 6 months of study enrollment
• Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease.
• Must have available tumor tissue for submission
• Subjects must also meet various laboratory parameters for inclusion (see Protocol section 3.3.1 item 4)
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 136
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
• Active CNS metastases within 30 days of study enrollment
• Subjects with any active autoimmune disease or a history of known autoimmune disease
• Subjects with uncontrolled adrenal insufficiency
• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.