Clinical trial · Interventional
Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients
Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients: the TONIC-2 Trial
NCT04159818CI-TRIAL-00057263TONIC-2recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single center non-blinded randomized multi-cohort non-comparative phase II trial with a Simon's two-stage design.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Low dose doxorubicin | Drug | Doxorubicin | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Control group
- description
- no induction treatment, nivolumab 240 mg flat-dose, every 2 weeks
- interventionNames
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Cisplatin induction
- description
- Cisplatin 40mg/m2, weekly for two weeks, after 2 weeks followed by nivolumab 240 mg flat-dose, every 2 weeks
- interventionNames
- Drug: Nivolumab
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Low dose doxorubicin induction
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic or incurable locally advanced triple negative breast cancer (ER \< 10%, HER2 IHC 0,1+ or 2+ with no 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. Treatment with low-dose doxorubicin in the palliative setting is not allowed. * 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 * Subjects with brain metastases are eligible if these are not symptomatic and free of progression of at least 4 weeks * A maximum dosage of 360 mg/m2 of anthracyclines and no previous anthracycline-related cardiac toxicity. In case of radiation in the cardiac area, hypertension, diabetes mellitus or hypercholesterolemia, the left ventricular ejection fraction must be 50% or higher. * Adequate bone marrow, kidney and liver function Exclusion Criteria: * 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. * active other cancer * history of uncontrolled serious medical or psychiatric illness * current pregnancy or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.