Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT01928394
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2013-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT02475382
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief Summary:
To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also investigated in PC.
Detailed Description:
All tumor types are now closed for enrollment:
Triple Negative Breast Cancer
Gastric Cancer
Pancreatic Cancer
Small Cell Lung Cancer
Bladder Cancer
Ovarian Cancer
Triple Negative Breast Cancer
Gastric Cancer
Pancreatic Cancer
Small Cell Lung Cancer
Bladder Cancer
Ovarian Cancer
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-002844-10 | EUDRACT_NUMBER | None | View |