RecruitingPhase 2NCT03606967

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

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine Vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer

Sponsor

National Cancer Institute (NCI)

Enrollment

70 participants

Start Date

Apr 13, 2021

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a personalized cancer vaccine combined with two immunotherapy drugs (durvalumab and tremelimumab) and standard chemotherapy for patients with triple-negative breast cancer that has spread to other parts of the body. Triple-negative breast cancer is a type that does not respond to hormone therapies. **You may be eligible if...** - You have been diagnosed with metastatic triple-negative breast cancer (confirmed by biopsy) - Your cancer does not express estrogen receptors, progesterone receptors, or HER2 (triple-negative) - Your cancer does not show a protein called PD-L1 on its surface - You are willing to undergo a tumor biopsy to create your personalized vaccine **You may NOT be eligible if...** - You have a type of breast cancer that tests positive for hormone receptors or HER2 - You have active autoimmune disease or cannot receive immunotherapy - You are pregnant or breastfeeding - You have serious heart or lung conditions Talk to your doctor to see if this trial is right for you.

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

PROCEDUREBiopsy Procedure

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood and urine sample collection

DRUGCarboplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT scan

BIOLOGICALDurvalumab

Given IV

DRUGGemcitabine Hydrochloride

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGNab-paclitaxel

Given IV

BIOLOGICALPersonalized Synthetic Long Peptide Vaccine

Given SC

DRUGPoly ICLC

Given SC

BIOLOGICALSacituzumab Govitecan

Given IV

BIOLOGICALTremelimumab

Given IV

Locations(30)

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

NYP/Weill Cornell Medical Center

New York, New York, United States

Wake Forest University at Clemmons

Clemmons, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

University of Texas Medical Branch

Galveston, Texas, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT03606967

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