Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer

Summary

This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Invasive Breast Carcinoma
• Metastatic Triple-Negative Breast Carcinoma

Interventions

PROCEDURE

Biopsy Procedure

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood and urine sample collection

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

BIOLOGICAL

Durvalumab

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Nab-paclitaxel

Given IV

BIOLOGICAL

Personalized Synthetic Long Peptide Vaccine

Given SC

DRUG

Poly ICLC

Given SC

BIOLOGICAL

Sacituzumab Govitecan

Given IV

BIOLOGICAL

Tremelimumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• William E Gillanders · Yale University Cancer Center LAO

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-13

Primary Completion

2026-12-30

Completion

2026-12-30

FDA Drug

Yes

Countries

• United States

Study Locations