Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
- Determine clinical response (partial and complete responses) in patients with
unresectable stage IV (locally or distantly metastatic) pancreatic adenocarcinoma
treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
- Determine whether observed responses correlate with the incidence of autoimmunity in
patients treated with this drug.
OUTLINE: 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.
PROJECTED ACCRUAL: A total of 42-82 patients (21-41 per stratum) will be accrued for this
study within 2-4 years.
Masking: Open Label, Primary Purpose: Treatment
Clinical response (complete and partial)
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|
|NCI - Surgery Branch||Bethesda, Maryland 20892-1201|