Finding studies
Finding studies
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Lead
Bristol-Myers Squibb
With
OBJECTIVES: Primary * 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 (MDX-010). Secondary * 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.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
