Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01383148
Status:
TERMINATED
Last Update Posted:
2017-01-05
First Post:
2011-06-23
Brief Title:
Phase IIBIII Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer
Sponsor:
Transgene
Organization:
Transgene
Study Overview
Official Title:
A Phase IIBIII Randomized Double-blind Placebo Controlled Study Comparing First Line Therapy With or Without TG4010 Immunotherapy Product in Patients With Stage IV Non-Small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2017-01
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:
TIME
Brief Summary:
This is a Phase IIbIII randomized double-blind placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer NSCLC
TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara MVA strain carrying coding sequences for human MUC1 antigen and human interleukin-2 IL2 TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen
TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a non-specific activation of several components of the immune system
TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara MVA strain carrying coding sequences for human MUC1 antigen and human interleukin-2 IL2 TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen
TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a non-specific activation of several components of the immune system
Detailed Description:
None
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 |
|---|---|---|---|
| 8559 | OTHER | FDA | None |