Search > Breast Cancer
30 Participants NeededMy employer runs this trial

cDC1 Vaccine + Trastuzumab/Nivolumab for Breast Cancer

JH
Overseen ByJulianne Hardesty
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

PF

Peter Forsyth, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with breast cancer that has spread to the lining of the brain and spinal cord (leptomeningeal disease). Participants must have either HER2-positive or HER2-negative breast cancer. Other major health issues may prevent participation.

Inclusion Criteria

I am 18 years old or older.
I have received at least whole brain radiotherapy, preferably with advanced techniques.
Life expectancy of at least 8 weeks
See 14 more

Exclusion Criteria

I have not received a live vaccine in the past 30 days.
Presence of shunts including ventriculoperitoneal or ventriculoatrial shunts
Severe acute or chronic medical or psychiatric conditions including recent or active suicidal ideation or behavior or lab abnormalities increasing risk or interfering with study
See 13 more

What Are the Treatments Tested in This Trial?

Interventions

  • cDC1 Vaccine
  • Nivolumab
  • Trastuzumab

Trial Overview

Researchers are testing a dendritic cell vaccine given directly into the fluid around the brain and spine, combined with trastuzumab for HER2-positive cases or nivolumab for HER2-negative cases, to find the safest dose.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Safety Run-In HER2- CohortExperimental Treatment2 Interventions
Group II: Safety Run-In HER2+ CohortExperimental Treatment2 Interventions
Group III: Phase 2 Efficacy CohortExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.