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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.

Phase 2RecruitingThe Netherlands Cancer InstituteNCT03815890Data as of May 2026

Treatment: Nivolumab · Ipilimumab · IpilimumabTo 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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