At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 27 enrolled
Drug / intervention
ipilimumabbiological
Likely dose
Not stated in record
Key inclusion· 5
- ✓Histologically confirmed pancreatic adenocarcinoma with Stage IV unresectable or metastatic disease
- ✓Clinically evaluable disease with at least 1 site of measurable disease
- ✓Age 18 and over
- ✓ECOG performance status 0-2
Key exclusion· 7
- ✕Non-adenocarcinoma pancreatic tumors: acinar cell carcinoma, pancreaticoblastoma, malignant cystic neoplasms, endocrine neoplasms, squamous cell carcinoma, Vater and periampullary duodenal or common bile duct malignancies
- ✕Active or prior autoimmune disease including uveitis or autoimmune inflammatory eye disease
- ✕Hepatitis B surface antigen positive or Hepatitis C positive (antibody positive and/or RNA positive)
- ✕HIV positive
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
In Brief
A Phase 2 clinical trial evaluating ipilimumab for Pancreatic Cancer. Completed, enrolled 27 participants across 2 sites.
Detailed Summary
RATIONALE: Biological therapies, such as MDX-010, may stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase II trial is studying how well MDX-010 works in treating patients with stage IV pancreatic cancer that cannot be removed by surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2005
Enrollment StartJul 2005
Primary CompletionJun 2009
TodayJul 2026
First PostedJun 3, 2005
Enrollment StartJul 31, 2005
Primary CompletionJun 30, 2009
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 21.1 years ago
Interventions
ipilimumabbiological