OncoMatch/Clinical Trials/NCT03815890
Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO
Is NCT03815890 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
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
Demographics
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.
Frequently asked questions
Is NCT03815890 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 expression <10% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression ≥10% is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
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