Spots Global Cancer Trial Database for Immunotherapy in High-risk Ductal Carcinoma in Situ (DCIS)

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Trial Identification

Brief Title: Immunotherapy in High-risk Ductal Carcinoma in Situ (DCIS)

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

Study ID: NCT02872025

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

Pembrolizumab

Intralesional mRNA 2752

Study Description

Brief 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) ): * 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. * 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): \*To determine the 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.