BridgeMD
Immune induction strategies to improve response to immune checkpoint blockade in triple negative breast cancer (TNBC) patients: the TONIC-2 trial
EU CTIS ID: 2024-513217-12-00
What this study is testing
To determine the activity of nivolumab after different immune response induction treatments in TNBC patients with metastatic disease
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Metastatic or incurable locally advanced triple negative breast cancer with confirmation of ER and HER2 negativity (ER <10% and HER2 IHC 0,1+ or 2+ in the absence of amplification)
- Metastatic lesion accessible for histological biopsy
- 18 years or older
- Maximum of three lines of chemotherapy for metastatic disease and with evidence of progression of disease
- WHO performance status of 0 or 1
- Measurable or evaluable disease according to RECIST 1.1
You likely can't join if
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris
- Known history of leptomeningeal disease localization
- History of having received other anticancer therapies within 2 weeks of start of the study drug
- History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mgl daily prednisone equivalents) or chronic infections
- Prior treatment with immune checkpoint inhibitors
See the full eligibility criteria
- Metastatic or incurable locally advanced triple negative breast cancer with confirmation of ER and HER2 negativity (ER <10% and HER2 IHC 0,1+ or 2+ in the absence of amplification)
- Metastatic lesion accessible for histological biopsy
- 18 years or older
- Maximum of three lines of chemotherapy for metastatic disease and with evidence of progression of disease
- WHO performance status of 0 or 1
- Measurable or evaluable disease according to RECIST 1.1
- Disease Free Interval (defined as time between first diagnosis or locoregional recurrence and first metastasis) longer than 1 year. This does not apply to patients with de novo metastatic disease or patients who did not receive (neo)adjuvant chemotherapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris
- Known history of leptomeningeal disease localization
- History of having received other anticancer therapies within 2 weeks of start of the study drug
- History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mgl daily prednisone equivalents) or chronic infections
- Prior treatment with immune checkpoint inhibitors
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.