Clinical Trial VICCURO1264
Title
A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
Principal Investigator(s)
Details
- Protocol No. VICCURO1264
- Open Date: 10/17/2012
- Staging: Phase III
- Age Group: Adults
- Scope: National
- Objective: To compare the clinical benefit, as measured by the duration of OS, provided by BMS-936558 vs everolimus in subjects with advanced or metastatic renal cell carcinoma who have received prior anti-angiogenic therapy.
- Disease Sites: Kidney (Renal Cell)
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Everolimus (RAD001); MDX-1106 (BMS-936558)
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01668784
- Secondary Protocol No: CA209025
Description
None Provided.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
Inclusion Criteria:
• Men & women ≥ 18 years of age
• Histologic confirmation of Renal cell carcinoma (RCC) with clear-cell component
• Advanced/metastatic RCC
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
• Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
• 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
• Karnofsky Performance Score ≥ 70%
Exclusion Criteria:
• Any Central Nervous System (CNS) metastases or history of CNS metastases
• Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor
• Any active known or suspected autoimmune disease.
• Uncontrolled adrenal insufficiency
• Active chronic liver disease
• Prior malignancy active within past 3 years, except for locally curable cancers
Learn More
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