Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342037
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-03-07
Brief Title:
NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer TNBC Patients TONIC-3 Trial
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer TNBC Patients TONIC-3 Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
TONIC-3
Brief Summary:
This is a single center non-blinded multi-cohort non-comparative phase II trial to study the safety and efficacy of tiragolumab with atezolizumab andor ipilimumab in advanced triple-negative breast cancer
Detailed Description:
Programmed cell death protein 1 PD1 -blockade is currently being approved for the neoadjuvant treatment of early TNBC as well as for first-line treatment in combination with chemotherapy for patients with Programmed cell death-ligand 1 PD-L1 -positive TNBC with metastatic disease However response rates are modest responses are not always durable and PD-L1 is a suboptimal biomarker to select patients for this regimen Therefore the overarching goal of this TONIC-3 study is to develop novel immunomodulatory strategies for patients with advanced TNBC making use state-of-the-art research tools to better understand the underlying cancer-immune interactions of this disease
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?:
None
Is an FDA AA801 Violation?:
None