Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112580
Status:
COMPLETED
Last Update Posted:
2021-09-27
First Post:
2005-06-02
Brief Title:
MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
Phase II Trial of Single Agent Ipilimumab MDX-010 Anti CTLA-4 for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MDX-010-24 | None | None | None |
| NCI-P6557 | None | None | None |
| NCI-05-C-0141 | None | None | None |