NCT02872025

Immunotherapy in High-risk Ductal Carcinoma in Situ (DCIS)

Testing the Ability of Immunotherapy to Alter the Tumor Immune MicroEnvionment (TIME) and Reduce or Eradicate High Risk DCIS

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Laura Esserman · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to investigate the change in the immune microenvironment of high risk ductal carcinoma in situ (DCIS) after short term exposure to immunotherapy.

Detailed description

PRIMARY OBJECTIVES: DOSE ESCALATION (Monotherapy Messenger RNA-2725 (mRNA-2752): I. To determine the efficacy of intralesional mRNA-2752 monotherapy in participants with ductal carcinoma in situ (DCIS) of the breast as measured by the change in the MRI tumor size/volume/enhancement. Absence of tumor on biopsy and increase in immune infiltrates as measured by immune multiplex assays. II. To characterize the safety of mRNA-2752 and feasibility of intralesional administration of mRNA-2752 in patients with high-risk DCIS. DOSE EXPANSION (mRNA-2752 with or without an immune checkpoint inhibitor): I. To determine the Magnetic resonance imaging (MRI) response rate and complete pathologic response rate with either mRNA-2752 monotherapy or combined therapy in high risk DCIS. ENROLLMENT IN THE PREVIOUS COHORTS HAS BEEN COMPLETED.

Conditions

• Carcinoma, Intraductal, Noninfiltrating

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Injected intralesionally
BIOLOGICAL	Intralesional mRNA 2752	Injected intralesionally

Timeline

• Start date: 2016-12-12
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2016-08-18
• Last updated: 2025-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study