Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
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.
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
Conditions
Interventions
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Carboplatin Drug
- Computed Tomography Procedure
- Durvalumab Biological
- Gemcitabine Hydrochloride Drug
- Magnetic Resonance Imaging Procedure
- Nab-paclitaxel Drug
- Personalized Synthetic Long Peptide Vaccine Biological
- Poly ICLC Drug
- Sacituzumab Govitecan Biological
- Tremelimumab Biological
Procedure · Drug · Biological
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
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03606967 live on ClinicalTrials.gov.