Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 791
- Locations
- 169
- Primary Endpoint
- Progression-Free Survival (PFS): Independent-Assessment
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
Intervention: Bevacizumab (Drug)
1
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
Intervention: Temsirolimus (Drug)
2
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
Intervention: Bevacizumab (Drug)
2
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
Intervention: Interferon-Alfa 9MU (Drug)
Outcomes
Primary Outcomes
Progression-Free Survival (PFS): Independent-Assessment
Time Frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
Secondary Outcomes
- Progression-Free Survival (PFS): Investigator-Assessment(Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))
- Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment(Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))
- Overall Survival (OS)(Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012))