Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer

Summary

Participation Requirements

Description

PRIMARY OBJECTIVES: I. To determine whether a statistically significant improvement in progression free survival exists for patients receiving the combination. SECONDARY OBJECTIVES: I. To determine whether the combination is safe and whether objective response rate (ORR), duration of response (DOR) ...

PRIMARY OBJECTIVES: I. To determine whether a statistically significant improvement in progression free survival exists for patients receiving the combination. SECONDARY OBJECTIVES: I. To determine whether the combination is safe and whether objective response rate (ORR), duration of response (DOR) and overall survival (OS) improve as a result of treatment with combination of axitinib + anti-OX40 antibody PF-04518600 (PF-04518600 [OX40 Ab]) compared to axitinib + placebo. TERTIARY OBJECTIVES: I. To determine whether pre and post treatment specimens collected during the trial demonstrate significant changes in tumor microenvironment and enhanced immune response to tumor cells. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive axitinib orally (PO) twice daily (BID) on days 1-14 and anti-OX40 antibody PF-04518600 intravenously (IV) over 60 minutes on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive axitinib as in Arm I and placebo IV on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30, 90, and 180 days.

Tracking Information