Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-03-10 @ 11:51 PM
Study NCT ID:
NCT02488759
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2015-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors
Status:
COMPLETED
Status Verified Date:
2023-11
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:
CheckMate358
Brief Summary:
The purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors:
* Anal canal cancer-No longer enrolling this tumor type
* Cervical cancer
* Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type
* Merkel Cell Cancer
* Penile cancer-No longer enrolling this tumor type
* Vaginal and vulvar cancer-No longer enrolling this tumor type
* Nasopharyngeal Cancer - No longer enrolling this tumor type
* Head and Neck Cancer - No longer enrolling this tumor type
* Anal canal cancer-No longer enrolling this tumor type
* Cervical cancer
* Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type
* Merkel Cell Cancer
* Penile cancer-No longer enrolling this tumor type
* Vaginal and vulvar cancer-No longer enrolling this tumor type
* Nasopharyngeal Cancer - No longer enrolling this tumor type
* Head and Neck Cancer - No longer enrolling this tumor type
Detailed Description:
None
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 |
|---|---|---|---|---|
| 2015-000230-29 | EUDRACT_NUMBER | None | View |