RecruitingPhase 2NCT04159818
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
Sponsor
The Netherlands Cancer Institute
Enrollment
52 participants
Start Date
Feb 21, 2020
Study Type
INTERVENTIONAL
Conditions
Summary
This is a single center non-blinded randomized multi-cohort non-comparative phase II trial with a Simon's two-stage design.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- 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
- 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 Criteria8
- 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
Interventions
DRUGNivolumab
240 mg flat-dose, every 2 weeks. From 20 weeks onwards, nivolumab will be administered every 4 weeks with a flat-dose of 480 mg starting from week 20 onwards
DRUGCisplatin
40mg/m2, weekly for two weeks
DRUGLow dose doxorubicin
15mg flat dose, weekly for 8 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04159818
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