Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects (INTORACT)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Renal Cell Carcinoma

Treatments: Drug: Interferon-Alfa 9MU; Drug: Temsirolimus; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631371

3066K1-3311

B1771006 (Other Identifier)

2007-003793-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 791 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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791 participants in 2 patient groups

1

Experimental group

Description:

Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly

Treatment:

Drug: Bevacizumab

Drug: Bevacizumab

Drug: Temsirolimus

2

Active Comparator group

Description:

Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW

Treatment:

Drug: Bevacizumab

Drug: Bevacizumab

Drug: Interferon-Alfa 9MU