Comparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objectives of the study are to determine the safety and activity of multiple doses of MDX-010 in patients with hormone-refractory prostate cancer (HRPC), and to determine the safety and activity profile of a single dose of cytotoxic chemotherapy (docetaxel) in combination with MDX-010

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Docetaxel; Hormones; Ipilimumab

Criteria

Inclusion Criteria:

• Clinical diagnosis of adenocarcinoma of the prostate.

• Metastatic prostate cancer (positive bone scan or measurable disease).

• Progressive disease after androgen deprivation.

• No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).

Exclusion Criteria:

• Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for greater than or equal to 5 years.

• Previous occurrence of autoimmune disease.

• Active infection requiring therapy including HIV or chronic hepatitis.