Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01265368
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
2010-12-22
Brief Title:
A Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine in Patients With Advanced Renal Cell Carcinoma ASET
Sponsor:
Mologen AG
Organization:
Mologen AG
Study Overview
Official Title:
A Phase 12 Proof-of-Principle Multi-Center Open-Label Single-Arm Non-randomized Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine Consisting of Genetically Modified Allogeneic Human Tumor Cells for the Expression of IL-7 GM-CSF CD80 and CD154 in Fixed Combination With a DNA-based Double Stem Loop Immunomodulator in Patients With Advanced Renal Cell Carcinoma ASET Study
Status:
COMPLETED
Status Verified Date:
2018-11
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:
ASET
Brief Summary:
This is a Phase 12 proof-of-principle clinical study to assess safety and efficacy of a intradermally administered tumor vaccine MGN1601 The study will be conducted in patients with advanced renal cell carcinoma
Detailed Description:
Twenty four patients with advanced RCC will be included in this open single-arm study
The treatment will last 12 weeks The investigational product MGN1601 will be administered intradermally for a total of 8 applications whereas the first 3 applications will be administered weekly and the following 5 applications will be administered bi-weekly
Patients who will develop disease control CR PR or SD by week 12 will be proposed to participate in the extension phase of the study The extension phase will be continued until disease progression in each patient however maximally up to week 120 total treatment duration 25 years During this time period the investigational product will be administered 5 times by weeks 24 36 48 72 and 120
The treatment will last 12 weeks The investigational product MGN1601 will be administered intradermally for a total of 8 applications whereas the first 3 applications will be administered weekly and the following 5 applications will be administered bi-weekly
Patients who will develop disease control CR PR or SD by week 12 will be proposed to participate in the extension phase of the study The extension phase will be continued until disease progression in each patient however maximally up to week 120 total treatment duration 25 years During this time period the investigational product will be administered 5 times by weeks 24 36 48 72 and 120
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 |
|---|---|---|---|
| 2009-016853-16 | EUDRACT_NUMBER | None | None |