OncoMatch/Clinical Trials/NCT04159818
Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients
Is NCT04159818 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Cisplatin for metastatic breast cancer.
Treatment: Nivolumab · Cisplatin · Low dose doxorubicin — This is a single center non-blinded randomized multi-cohort non-comparative phase II trial with a Simon's two-stage design.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 low expression (< 10%)
ER < 10%
Required: HER2 (ERBB2) negative (IHC 0, 1+ or 2+ with no amplification)
HER2 IHC 0,1+ or 2+ with no amplification
Performance status
WHO 0–1
Prior therapy
Cannot have received: immune checkpoint inhibitor
prior treatment with immune checkpoint inhibitors
Cannot have received: doxorubicin (low-dose, palliative setting) (doxorubicin)
Treatment with low-dose doxorubicin in the palliative setting is not allowed
Lab requirements
Blood counts
adequate bone marrow function
Kidney function
adequate kidney function
Liver function
adequate liver function
Cardiac function
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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