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Recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT03606967

Public ClinicalTrials.gov record NCT03606967. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 2:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03606967
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
86 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 12, 2021
Primary completion
Dec 29, 2026
Completion
Dec 29, 2026
Last update posted
Aug 9, 2026

2021 – 2026

United States locations

U.S. sites
30
U.S. states
14
U.S. cities
25
Facility City State ZIP Site status
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California 92868 Active, not recruiting
University of California Davis Comprehensive Cancer Center Sacramento California 95817 Terminated
UCHealth University of Colorado Hospital Aurora Colorado 80045 Recruiting
Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut 06105 Active, not recruiting
Yale University New Haven Connecticut 06520 Active, not recruiting
UM Sylvester Comprehensive Cancer Center at Aventura Aventura Florida 33180 Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida 33146 Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida 33442 Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida 33136 Recruiting
UM Sylvester Comprehensive Cancer Center at Kendall Miami Florida 33176 Recruiting
UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida 33324 Recruiting
Moffitt Cancer Center-International Plaza Tampa Florida 33607 Recruiting
Moffitt Cancer Center - McKinley Campus Tampa Florida 33612 Recruiting
Moffitt Cancer Center Tampa Florida 33612 Recruiting
Moffitt Cancer Center at Wesley Chapel Wesley Chapel Florida 33544 Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland 21287 Recruiting
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters Missouri 63376 Recruiting
Siteman Cancer Center at West County Hospital Creve Coeur Missouri 63141 Recruiting
Washington University School of Medicine St Louis Missouri 63110 Recruiting
Siteman Cancer Center-South County St Louis Missouri 63129 Recruiting
Siteman Cancer Center at Christian Hospital St Louis Missouri 63136 Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire 03756 Suspended
NYP/Weill Cornell Medical Center New York New York 10065 Recruiting
Wake Forest University at Clemmons Clemmons North Carolina 27012 Recruiting
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 Recruiting
Ohio State University Comprehensive Cancer Center Columbus Ohio 43210 Recruiting
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 Active, not recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232 Recruiting
University of Texas Medical Branch Galveston Texas 77555-0565 Suspended
VCU Massey Comprehensive Cancer Center Richmond Virginia 23298 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03606967, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 9, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03606967 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →