OncoMatch/Clinical Trials/NCT03815890
Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO
Is NCT03815890 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Ipilimumab for breast cancer.
Treatment: Nivolumab · Ipilimumab · Ipilimumab — To determine whether short-term pre-operative nivolumab either as monotherapy or in combination with low dose doxorubicin or novel IO combinations can induce immune activation in early BC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression <10% (<10%)
TNBC defined as ER<10%
Required: HER2 (ERBB2) negative (IHC <2 or 2+ with negative ISH)
HER2 negative is defined as an IHC score of <2 or 2+ with a negative ISH
Required: ESR1 expression ≥10% (≥10%)
luminal B defined as ER≥10%
Required: HER2 (ERBB2) negative (IHC <2 or 2+ with negative ISH)
HER2 negative is defined as an IHC score of <2 or 2+ with a negative ISH
Allowed: PR (PGR) expression ≤20%
luminal B defined as ER≥10%, HER2-negative with either Ki67≥20% or PR =<20% OR grade 3
Allowed: MKI67 expression ≥20%
luminal B defined as ER≥10%, HER2-negative with either Ki67≥20% or PR =<20% OR grade 3
Disease stage
Required: Stage I, II, III
Performance status
WHO 0–1
Prior therapy
Cannot have received: radiation therapy
previous radiation therapy
Cannot have received: cytotoxic chemotherapy
previous chemotherapy
Cannot have received: checkpoint inhibitor
prior treatment with checkpoint inhibitors (including anti- PD1, -PD-L1, -CTLA-4)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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