OncoMatch/Clinical Trials/NCT06218303
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
Is NCT06218303 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including MUC1 Peptide Vaccine and Hiltonol® for ductal carcinoma in situ.
Treatment: MUC1 Peptide Vaccine · Hiltonol® · Aromatase Inhibitor · Selective estrogen receptor modulator (SERM) — Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator (SERM) for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator and MUC1 vaccination (MUC1 peptide + Hiltonol®) pre-operatively at baseline, and weeks 2 and 10, followed by surgery at about 12 weeks. Patients in the vaccine cohort will be offered an optional boost vaccine 6 months after surgery.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: ESR1 overexpression (ER+)
Biopsy-proven ER+ DCIS
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: hormone replacement therapy
Exception: wash out of 30 days must occur prior to baseline biopsy for the study
Current hormone replacement therapy, selective estrogen receptor modulator therapy, or aromatase inhibitor therapy--if yes, wash out of 30 days must occur prior to baseline biopsy for the study
Cannot have received: selective estrogen receptor modulator
Exception: wash out of 30 days must occur prior to baseline biopsy for the study
Current hormone replacement therapy, selective estrogen receptor modulator therapy, or aromatase inhibitor therapy--if yes, wash out of 30 days must occur prior to baseline biopsy for the study
Cannot have received: aromatase inhibitor
Exception: wash out of 30 days must occur prior to baseline biopsy for the study
Current hormone replacement therapy, selective estrogen receptor modulator therapy, or aromatase inhibitor therapy--if yes, wash out of 30 days must occur prior to baseline biopsy for the study
Cannot have received: investigational vaccine, drug, or device
Participation on any investigational vaccine, drug, or device trial within the last 30 days
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; Hemoglobin ≥ 9 g/dl or ≥ 5.6 mmol/L
Kidney function
Creatinine ≤ 1.5X the upper limit of normal OR creatinine clearance ≥ 60 ml/min
Liver function
Total bilirubin ≤ 1.5X the ULN; ≤ 2x ULN for patients with Gilbert's disease. AST and ALT ≤ 2.5X ULN
Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; Hemoglobin ≥ 9 g/dl or ≥ 5.6 mmol/L; Creatinine ≤ 1.5X the upper limit of normal OR creatinine clearance ≥ 60 ml/min; Total bilirubin ≤ 1.5X the ULN; ≤ 2x ULN for patients with Gilbert's disease; AST and ALT ≤ 2.5X ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UPMC Magee Womens Hospital · Pittsburgh, Pennsylvania
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