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

PHASE2RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

April 13, 2021

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Anatomic Stage IV Breast Cancer AJCC v8Invasive Breast CarcinomaMetastatic 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

Trial Locations (30)

10065

RECRUITING

NYP/Weill Cornell Medical Center, New York

15232

RECRUITING

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

21287

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

23298

RECRUITING

VCU Massey Comprehensive Cancer Center, Richmond

27012

RECRUITING

Wake Forest University at Clemmons, Clemmons

27157

RECRUITING

Wake Forest University Health Sciences, Winston-Salem

33136

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

33146

RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables

33176

RECRUITING

UM Sylvester Comprehensive Cancer Center at Kendall, Miami

33180

RECRUITING

UM Sylvester Comprehensive Cancer Center at Aventura, Aventura

33324

RECRUITING

UM Sylvester Comprehensive Cancer Center at Plantation, Plantation

33442

RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach

33544

RECRUITING

Moffitt Cancer Center at Wesley Chapel, Wesley Chapel

33607

RECRUITING

Moffitt Cancer Center-International Plaza, Tampa

33612

RECRUITING

Moffitt Cancer Center - McKinley Campus, Tampa

RECRUITING

Moffitt Cancer Center, Tampa

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

63110

RECRUITING

Washington University School of Medicine, St Louis

63129

RECRUITING

Siteman Cancer Center-South County, St Louis

63136

RECRUITING

Siteman Cancer Center at Christian Hospital, St Louis

63141

RECRUITING

Siteman Cancer Center at West County Hospital, Creve Coeur

63376

RECRUITING

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

73104

ACTIVE_NOT_RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

80045

RECRUITING

UCHealth University of Colorado Hospital, Aurora

92868

ACTIVE_NOT_RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

95817

RECRUITING

University of California Davis Comprehensive Cancer Center, Sacramento

06105

ACTIVE_NOT_RECRUITING

Smilow Cancer Hospital Care Center at Saint Francis, Hartford

06520

ACTIVE_NOT_RECRUITING

Yale University, New Haven

03756

SUSPENDED

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

77555-0565

RECRUITING

University of Texas Medical Branch, Galveston

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH