Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-02-20 @ 3:45 PM
Study NCT ID:
NCT03066427
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2017-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Efficacy and Safety of Sunitinib in Renal Cell Carcinoma Progressed to 1L Immunotherapy Treatment.
Sponsor:
Spanish Oncology Genito-Urinary Group
Organization:
Study Overview
Official Title:
Phase II Study to Evaluate Efficacy and Safety of Sunitinib Therapy in Patients With Metastatic Renal Clear Cell Carcinoma Who Have Progressed to First-line Immunotherapy Treatment (INMUNOSUN Study)
Status:
COMPLETED
Status Verified Date:
2020-10
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:
INMUNOSUN
Brief Summary:
The therapeutic scenario of metastatic renal cancer is undergoing a new revolution with the appearance of a novel therapeutic strategy after the antiangiogenic treatments, that is the immunotherapy, in addition to the approval of new active drugs in the following lines of treatment.
There are currently two phase III trials in the first line of treatment in metastatic renal cancer that include different combinations of treatment based on immunotherapy. If results of these studies were positive, the therapeutic algorithm would be modified so that the remaining drugs would have to be repositioned within the therapeutic decision scheme.
Sunitinib has previously demonstrated its benefit in patients who had failed to prior treatment with cytokines, so it is likely to continue to be effective in patients who have become resistant to treatment with new drugs based on immune checkpoint blockade.
This phase II study is developed to evaluate the activity of sunitinib after treatment with immunotherapy-based regimens that are currently being developed within phase III clinical trials.
There are currently two phase III trials in the first line of treatment in metastatic renal cancer that include different combinations of treatment based on immunotherapy. If results of these studies were positive, the therapeutic algorithm would be modified so that the remaining drugs would have to be repositioned within the therapeutic decision scheme.
Sunitinib has previously demonstrated its benefit in patients who had failed to prior treatment with cytokines, so it is likely to continue to be effective in patients who have become resistant to treatment with new drugs based on immune checkpoint blockade.
This phase II study is developed to evaluate the activity of sunitinib after treatment with immunotherapy-based regimens that are currently being developed within phase III clinical trials.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|---|
| 2016-004011-12 | EUDRACT_NUMBER | None | View |