Phase II Study of Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody (MDX-010) in Patients With Unresectable Stage IV (Locally or Distantly Metastatic) Pancreatic Adenocarcinoma
First Published: 5/23/2005  Last Modified: 9/20/2010
MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
Basic Trial Information
Special Category: NCI Web site featured trial
A total of 42-82 patients (21-41 per stratum) will be accrued for this study within 2-4 years.
Clinical response (complete and partial)
Incidence of autoimmunity
This is an open-label study. Patients are stratified according to status of disease (locally vs distantly metastatic).
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on days 0, 21, 42, and 63. Treatment repeats every 84 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression after achieving a partial response or complete response receive 2 additional courses of therapy.
After completion of study treatment, patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Royal RE, Levy C, Turner K, et al.: Phase 2 trial of single agent Ipilimumab (anti-CTLA-4) for locally advanced or metastatic pancreatic adenocarcinoma. J Immunother 33 (8): 828-33, 2010.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
NCI - Center for Cancer Research
Steven Rosenberg, MD, PhD, Principal investigator
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.