RecruitingPhase 2NCT07694986

Trial of Therapies With IT cDC1s Combined w/ IT Trastuzamab for Her+ or IT Nivolumab for Her- BC LMD

Phase 2 Trial With a Safety Run-in of Combinatorial Therapies With Intrathecal (IT) Dendritic Cell Vaccines (cDC1s) inHER+ (Combined With IT Trastuzumab) and HER2- (Combined With IT Nivolumab) Breast Cancer (BC) Leptomeningeal Disease (LMD)


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

30 participants

Start Date

Aug 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to learn about the effects of the study treatment, Dendritic Cell Vaccine (DCV), in combination with trastuzumab or nivolumab to confirm the highest dose of the study treatment that can be given safely to participants with Breast Cancer (BC) with Leptomeningeal Disease (LMD).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Nivolumab, a drug called Trastuzumab, and others for people with breast cancer and leptomeningeal disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALcDC1 Vaccine

Autologous peptide-pulsed cDC1 vaccine administered intrathecally.

DRUGTrastuzumab

150 mg intrathecal weekly for HER2-positive participants.

DRUGNivolumab

50 mg intrathecal every 2 weeks for HER2-negative participants.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT07694986


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