Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332274
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-02-29
Brief Title:
tislelizUMaB in canceR Patients With molEcuLar residuaL Disease
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
tislelizUMaB in canceR Patients With molEcuLar residuaL Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
UMBRELLA
Brief Summary:
Numerous studies have shown that even when imaging does not reveal the presence of cancer cells traces of tumor DNA ie originating from cancer cells can be detected in the blood of certain patients this is called molecular residual disease MRD When such traces are detected we speak of MRD status the risk of relapse is much higher than when there is no circulating tumor DNA MRD - status Given the success of immunotherapy in treating patients with metastatic disease in a variety of tumor types there is enormous enthusiasm for expanding the use of immunotherapy to people with cancer at an early stage
UMBRELLA is a biology-driven trial designed to study the impact of systemic treatment with tislelizumab monotherapy after detection of MRD status after completion of surgery and perioperative treatments in patients with cancer of a solid tumor Residual disease MRD will be determined by optimized detection and precise monitoring of circulating tumor DNA enabling early detection of recurrence and disease monitoring including in patients without MRD MRD-
UMBRELLA is a biology-driven trial designed to study the impact of systemic treatment with tislelizumab monotherapy after detection of MRD status after completion of surgery and perioperative treatments in patients with cancer of a solid tumor Residual disease MRD will be determined by optimized detection and precise monitoring of circulating tumor DNA enabling early detection of recurrence and disease monitoring including in patients without MRD MRD-
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20233720 | OTHER | CSET number | None |