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Clinical Trials in the Netherlands / NCT04159818
Recruiting Phase 2

Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients

NCT04159818 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 2
Started
2020-02-21
Last updated
2022-03-22

Condition(s) studied

Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

Nivolumab →Cisplatin →Low dose doxorubicin →

Nivolumab: 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

Cisplatin: 40mg/m2, weekly for two weeks

Low dose doxorubicin: 15mg flat dose, weekly for 8 weeks

Study summary

This is a single center non-blinded randomized multi-cohort non-comparative phase II trial with a Simon's two-stage design.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Antoni van Leeuwenhoek Amsterdam Netherlands Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04159818 on ClinicalTrials.gov ↗ ← All trials in the Netherlands