Overview

Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer

Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Antibodies, Monoclonal
Hormones
Ipilimumab