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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
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.
Frequently asked questions
Is NCT04159818 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune checkpoint inhibitor, doxorubicin (low-dose, palliative setting) disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 low expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages