Phase 3
Completed N=791
Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
Source: ClinicalTrials.gov NCT00631371 ↗Enrolled (actual)
791
Serious AEs
43.6%
Results posted
Jun 2013
Primary outcomePrimary: Progression-Free Survival (PFS): Independent-Assessment — 9.1; 9.3 months — p=0.8
Summary
Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS): Independent-Assessment |
9.1; 9.3 | 0.8 |
| SECONDARY Progression-Free Survival (PFS): Investigator-Assessment |
9.1; 10.8 | 0.9 |
| SECONDARY Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment |
27.0; 27.4 | 1.0 |
| SECONDARY Overall Survival (OS) |
25.8; 25.5 | 0.6 |
Eligibility Criteria
Inclusion Criteria
- Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC)
- Majority component of conventional clear-cell type is mandatory
- At least 1 measurable lesion (per RECIST)
Exclusion Criteria
- Prior systemic treatment for RCC
- Evidence of current or prior central nervous system (CNS) metastases
- Cardiovascular disease
- Pregnant or nursing women
- Additional criteria applies
Data sourced from ClinicalTrials.gov (NCT00631371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.