NCT02499367Active, not recruitingPhase 2
Adaptive phase II randomized non-comparative trial of nivolumab after induction treatment in triple-negative breast cancer (TNBC) patients: TONIC-trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 Jan 2025
Brief summary (registry, in English)
To determine the activity of nivolumab after four different immune response induction treatments in TNBC patients with metastatic disease. We hypothesize that short-term induction treatment with radiation, doxorubicin, cyclophosphamide or cisplatin induces an anticancer immune response resulting in increased activity of nivolumab as compared to unprimed, single agent nivolumab.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 14 Jan 2025
- Start date
- 8 Sept 2015
- Lead sponsor
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- NCT number
- NCT02499367
- EU CT number
- 2025-520487-18-00
- EudraCT number
- 2015-001969-49
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 84
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known leptomenigeal disease localization
- History of having recceived other anticancer therapies within 2 weeks of start of the study drug
- History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mg daily prednisone equivalents) or chronic infections
Other
- Current pregnancy or breastfeeding
Who the study is looking for
- Metastatic ER and HER2 negative breast cancer
- 18 years or older
- Metastatic lesions accessible for histological biopsy
- Maximum of three lines of chemotherapy for metastatic disease
- Evaluable disease according to RECIST 1.1
- WHO performance status 0 or 1
- Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment is completed and prior to first dose of study drug administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
- Signed written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
Related publications
- CfDNA-based copy-number dynamics during anti-PD1 treatment in metastatic triple negative breast cancer.Cell Rep Med · 2025 · PMID 41406937
This page is information, not medical advice. Discuss any trial with your doctor.