Trial Title:
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/NSABP B-63)
NCT ID:
NCT05633654
Condition:
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Pembrolizumab
Capecitabine
Sacituzumab govitecan
Conditions: Keywords:
OptimICE-RD
AFT-65
NSABP B-63
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sacituzumab govitecan-hziy (SG)
Description:
Administered intravenously
Arm group label:
Sacituzumab govitecan-hziy (SG) + Pembrolizumab
Other name:
GS-0132
Other name:
IMMU-132
Other name:
Trodelvy™
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Administered intravenously
Arm group label:
Sacituzumab govitecan-hziy (SG) + Pembrolizumab
Arm group label:
Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine
Other name:
KEYTRUDA®
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Tablets administered orally
Arm group label:
Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine
Other name:
Xeloda
Summary:
The goal of this study is to find out if the experimental product, sacituzumab
govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective
and safe compared to the treatment of physician's choice (TPC) which includes either
pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative
breast cancer that still remains after surgery and pre-surgical treatment.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the
breast or lymph nodes after neoadjuvant therapy and surgery:
- TNBC criteria for the study is defined as estrogen receptor (ER) and
progesterone receptor (PR) < 10%, human epidermal growth factor receptor 2
(HER2)-negative per American Society of Clinical Oncology and College of
American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or
in situ hybridization (ISH)).
- Adequate excision and surgical removal of all clinically evident of disease in the
breast and/or lymph nodes and have adequately recovered from surgery.
- Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual
invasive disease tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Individuals must have received appropriate radiotherapy and have recovered prior to
starting study treatment.
- Adequate organ function.
Key Exclusion Criteria:
- Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or
contralateral) invasive breast cancer.
- Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg,
cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of
differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior or
concurrent treatment with any endocrine therapy agent.
- Evidence of recurrent disease following preoperative therapy and surgery.
- Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs)
containing a topoisomerase inhibitor.
- Individuals with germline breast cancer gene (BRCA) mutations.
- Myocardial infarction or unstable angina pectoris within 6 months of enrollment or
history of serious ventricular arrhythmia (ie, ventricular tachycardia or
ventricular fibrillation), high-grade atrioventricular block, or other cardiac
arrhythmias or Left ventricular ejection fraction (LVEF) of < 50%
- Active serious infections requiring anti-microbial therapy.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Alabama Oncology
Address:
City:
Birmingham
Zip:
35243
Country:
United States
Status:
Recruiting
Facility:
Name:
Clearview Cancer Institute
Address:
City:
Huntsville
Zip:
35805
Country:
United States
Status:
Recruiting
Facility:
Name:
Palo Verde Hematology Oncology
Address:
City:
Glendale
Zip:
85304
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic Hospital
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Facility:
Name:
Arizona Oncology Associates
Address:
City:
Prescott Valley
Zip:
86314
Country:
United States
Status:
Recruiting
Facility:
Name:
Alta Bates Summit Medical Center
Address:
City:
Berkeley
Zip:
94704
Country:
United States
Status:
Recruiting
Facility:
Name:
Community Cancer Institute
Address:
City:
Clovis
Zip:
93611
Country:
United States
Status:
Recruiting
Facility:
Name:
PIH Health Whittier Hospital
Address:
City:
Downey
Zip:
90241
Country:
United States
Status:
Recruiting
Facility:
Name:
Compassionate Cancer Care Medical Group - Inc
Address:
City:
Fountain Valley
Zip:
92708
Country:
United States
Status:
Recruiting
Facility:
Name:
Los Angeles Cancer Network
Address:
City:
Los Angeles
Zip:
90017
Country:
United States
Status:
Recruiting
Facility:
Name:
USC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
Hoag Memorial Hospital Presbyterian
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Recruiting
Facility:
Name:
Emad Ibrahim, MD, INC
Address:
City:
Redlands
Zip:
92373
Country:
United States
Status:
Withdrawn
Facility:
Name:
Sutter Institute for Medical Research
Address:
City:
Sacramento
Zip:
95816
Country:
United States
Status:
Recruiting
Facility:
Name:
UCSF Medical Center
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Facility:
Name:
Sansum Clinic
Address:
City:
Santa Barbara
Zip:
93105
Country:
United States
Status:
Recruiting
Facility:
Name:
Stockton Hematology Oncology Medical Group
Address:
City:
Stockton
Zip:
95204
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Colorado Cancer Center
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Facility:
Name:
Norwalk Hospital
Address:
City:
Danbury
Zip:
06810
Country:
United States
Status:
Recruiting
Facility:
Name:
Stamford Hospital
Address:
City:
Stamford
Zip:
06902
Country:
United States
Status:
Recruiting
Facility:
Name:
Morton Plant Hospital - Bay Care
Address:
City:
Clearwater
Zip:
00337
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Florida
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer Specialists of North Florida
Address:
City:
Jacksonville
Zip:
32256
Country:
United States
Status:
Recruiting
Facility:
Name:
Jupiter Medical Center
Address:
City:
Jupiter
Zip:
33458
Country:
United States
Status:
Recruiting
Facility:
Name:
Mount Sinai Comprehensive Cancer Center
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Recruiting
Facility:
Name:
Midland Florida Clinical Research Center, L
Address:
City:
Orange City
Zip:
32763
Country:
United States
Status:
Recruiting
Facility:
Name:
Orlando Health
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer Care Centers of Brevard, Inc
Address:
City:
Palm Bay
Zip:
32909
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Healthcare System
Address:
City:
Pembroke Pines
Zip:
33028
Country:
United States
Status:
Recruiting
Facility:
Name:
Sacred Heart Medical Oncology Group
Address:
City:
Pensacola
Zip:
32504
Country:
United States
Status:
Recruiting
Facility:
Name:
Sylvester Comprehensive Cancer Center
Address:
City:
Plantation
Zip:
33324
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic Florida, Martin North Hospital
Address:
City:
Stuart
Zip:
34994
Country:
United States
Status:
Recruiting
Facility:
Name:
St. Joseph's Hospital
Address:
City:
Tampa
Zip:
33614
Country:
United States
Status:
Recruiting
Facility:
Name:
Weston Hospital
Address:
City:
Weston
Zip:
33331
Country:
United States
Status:
Recruiting
Facility:
Name:
University Cancer & Blood Center, LLC.
Address:
City:
Athens
Zip:
30607
Country:
United States
Status:
Recruiting
Facility:
Name:
Piedmont Cancer Institute
Address:
City:
Atlanta
Zip:
30318
Country:
United States
Status:
Recruiting
Facility:
Name:
Northside Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Georgia Oncology Centers, PC
Address:
City:
Marietta
Zip:
30060
Country:
United States
Status:
Recruiting
Facility:
Name:
Pearlman Cancer Center
Address:
City:
Valdosta
Zip:
31602
Country:
United States
Status:
Recruiting
Facility:
Name:
St Lukes Mountain States Tumor Institute
Address:
City:
Boise
Zip:
83712
Country:
United States
Status:
Recruiting
Facility:
Name:
Kootenai Health
Address:
City:
Coeur d'Alene
Zip:
83814
Country:
United States
Status:
Recruiting
Facility:
Name:
Rush University Medical Center
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Illinois
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Facility:
Name:
NorthShore University Healthsystem
Address:
City:
Evanston
Zip:
60201
Country:
United States
Status:
Recruiting
Facility:
Name:
Edward Hospital
Address:
City:
Naperville
Zip:
60540
Country:
United States
Status:
Recruiting
Facility:
Name:
West Suburban Medical Center- River Forest
Address:
City:
River Forest
Zip:
60305
Country:
United States
Status:
Recruiting
Facility:
Name:
Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
Address:
City:
Skokie
Zip:
60076
Country:
United States
Status:
Withdrawn
Facility:
Name:
Springfield Clinic LLP
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Facility:
Name:
Carle Cancer Center
Address:
City:
Urbana
Zip:
61801
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Clinical Research of Indiana, LLC
Address:
City:
Indianapolis
Zip:
46260
Country:
United States
Status:
Recruiting
Facility:
Name:
IU Health Arnett Hospital
Address:
City:
Lafayette
Zip:
47904
Country:
United States
Status:
Recruiting
Facility:
Name:
Franciscan Health Munster
Address:
City:
Munster
Zip:
46321
Country:
United States
Status:
Recruiting
Facility:
Name:
Mercy Medical Center
Address:
City:
Cedar Rapids
Zip:
52403
Country:
United States
Status:
Recruiting
Facility:
Name:
Mission Cancer & Blood - John Stoddard Cancer Center
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Iowa Hospitals and Clinics
Address:
City:
Fairfield
Zip:
52556
Country:
United States
Status:
Recruiting
Facility:
Name:
Franciscan Health Indianapolis
Address:
City:
Indianapolis
Zip:
46237
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Kentucky
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Facility:
Name:
Norton Healthcare, Inc.
Address:
City:
Louisville
Zip:
40207
Country:
United States
Status:
Recruiting
Facility:
Name:
Mercy Health
Address:
City:
Paducah
Zip:
42003
Country:
United States
Status:
Recruiting
Facility:
Name:
Mary Bird Perkins Cancer Center
Address:
City:
Baton Rouge
Zip:
70809
Country:
United States
Status:
Recruiting
Facility:
Name:
University Medical Center New Orleans
Address:
City:
New Orleans
Zip:
70112
Country:
United States
Status:
Recruiting
Facility:
Name:
New England Cancer Specialists
Address:
City:
Scarborough
Zip:
04074
Country:
United States
Status:
Recruiting
Facility:
Name:
Sinai Hospital of Baltimore, Inc.
Address:
City:
Baltimore
Zip:
21215
Country:
United States
Status:
Recruiting
Facility:
Name:
St. Agnes Hospital
Address:
City:
Baltimore
Zip:
21229
Country:
United States
Status:
Recruiting
Facility:
Name:
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Status:
Recruiting
Facility:
Name:
Medstar Franklin Square Medical Center
Address:
City:
Baltimore
Zip:
21237
Country:
United States
Status:
Recruiting
Facility:
Name:
American Oncology Partners of Maryland, PA
Address:
City:
Bethesda
Zip:
20817
Country:
United States
Status:
Withdrawn
Facility:
Name:
James M Stockman Cancer Institute
Address:
City:
Frederick
Zip:
21702
Country:
United States
Status:
Recruiting
Facility:
Name:
Greater Baltimore Medical Center
Address:
City:
Towson
Zip:
21204
Country:
United States
Status:
Recruiting
Facility:
Name:
Tufts Medical Center
Address:
City:
Boston
Zip:
02111
Country:
United States
Status:
Recruiting
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Baystate Medical Center Inc.
Address:
City:
Springfield
Zip:
01199
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry Ford Health System
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer and Hematology Centers of Western Michigan
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Facility:
Name:
Ascension
Address:
City:
Grosse Pointe Woods
Zip:
48236
Country:
United States
Status:
Recruiting
Facility:
Name:
William Beaumont Hospital
Address:
City:
Royal Oak
Zip:
48073
Country:
United States
Status:
Recruiting
Facility:
Name:
Ascension Providence Hospital Southfield Cancer Center
Address:
City:
Southfield
Zip:
48075
Country:
United States
Status:
Recruiting
Facility:
Name:
Trinity Health St. Joseph Mercy Ann Arbor
Address:
City:
Ypsilanti
Zip:
48197
Country:
United States
Status:
Recruiting
Facility:
Name:
Minnesota Oncology Hematology, PA
Address:
City:
Maplewood
Zip:
55109
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Piper Cancer Center (Allina Health)
Address:
City:
Minneapolis
Zip:
55407
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Minnesota Medical Center, Fairview
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Facility:
Name:
Metro Minnesota Community Oncology
Address:
City:
Saint Louis Park
Zip:
55426
Country:
United States
Status:
Recruiting
Facility:
Name:
Baptist Clinical Research Institute
Address:
City:
Saint Louis
Zip:
63131
Country:
United States
Status:
Recruiting
Facility:
Name:
Mercy Hospital
Address:
City:
Saint Louis
Zip:
63141
Country:
United States
Status:
Recruiting
Facility:
Name:
Mary Lanning Healthcare - Morrison Cancer Center
Address:
City:
Hastings
Zip:
68901
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Hematology West - Methodist
Address:
City:
Omaha
Zip:
68114
Country:
United States
Status:
Recruiting
Facility:
Name:
Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
Address:
City:
Omaha
Zip:
68124
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Cancer Centers of Nevada
Address:
City:
Las Vegas
Zip:
89169
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer Care & Hematology Specialists
Address:
City:
Reno
Zip:
89511
Country:
United States
Status:
Recruiting
Facility:
Name:
Regional Cancer Care Associates LLC
Address:
City:
East Brunswick
Zip:
08816
Country:
United States
Status:
Recruiting
Facility:
Name:
Hunterdon Medical Center
Address:
City:
Flemington
Zip:
08822
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Medical Group, P.A.
Address:
City:
Florham Park
Zip:
07932
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Health
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
Overlook Medical Center
Address:
City:
Summit
Zip:
07901
Country:
United States
Status:
Recruiting
Facility:
Name:
University of New Mexico
Address:
City:
Albuquerque
Zip:
87131
Country:
United States
Status:
Recruiting
Facility:
Name:
San Juan Oncology Associates
Address:
City:
Farmington
Zip:
87401
Country:
United States
Status:
Recruiting
Facility:
Name:
New York Oncology Hematology (NYOH)
Address:
City:
Amsterdam
Zip:
12010
Country:
United States
Status:
Recruiting
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Facility:
Name:
Hematology Oncology Associates of Central New York, PC
Address:
City:
East Syracuse
Zip:
13057
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwell Health
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Recruiting
Facility:
Name:
Laura and Isaac Perlmutter Cancer Canter
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
Lipson Cancer Institute - Linden Oaks
Address:
City:
Rochester
Zip:
14618
Country:
United States
Status:
Recruiting
Facility:
Name:
New York Cancer and Blood Specialists
Address:
City:
Shirley
Zip:
11967
Country:
United States
Status:
Recruiting
Facility:
Name:
Stony Brook Medicine
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Status:
Recruiting
Facility:
Name:
SUNY Upstate Medical University
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Research Alliance
Address:
City:
Westbury
Zip:
11590
Country:
United States
Status:
Recruiting
Facility:
Name:
White Plains Hospital Physician Associates
Address:
City:
White Plains
Zip:
10601
Country:
United States
Status:
Recruiting
Facility:
Name:
Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Recruiting
Facility:
Name:
Duke Cancer Institute
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
Cone Health Medical Group (Moses Cone Health System)
Address:
City:
Greensboro
Zip:
27403
Country:
United States
Status:
Recruiting
Facility:
Name:
East Carolina University Health Medical Center
Address:
City:
Greenville
Zip:
27834
Country:
United States
Status:
Recruiting
Facility:
Name:
FirstHealth Outpatient Cancer Center
Address:
City:
Pinehurst
Zip:
28374
Country:
United States
Status:
Recruiting
Facility:
Name:
UNC Rex Cancer Center
Address:
City:
Raleigh
Zip:
27607
Country:
United States
Status:
Recruiting
Facility:
Name:
UNC Nash Cancer Center
Address:
City:
Rocky Mount
Zip:
27804
Country:
United States
Status:
Recruiting
Facility:
Name:
Atrium Health Wake Forest Baptist
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Facility:
Name:
Good Samaritan Hospital
Address:
City:
Cincinnati
Zip:
45220
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Hematology Care, Inc.
Address:
City:
Cincinnati
Zip:
45242
Country:
United States
Status:
Recruiting
Facility:
Name:
Ohio State University CRS
Address:
City:
Columbus
Zip:
43212
Country:
United States
Status:
Recruiting
Facility:
Name:
Ohio Health Research Institute
Address:
City:
Columbus
Zip:
43214
Country:
United States
Status:
Recruiting
Facility:
Name:
Anita Stewart Oncology Center
Address:
City:
Columbus
Zip:
43221
Country:
United States
Status:
Recruiting
Facility:
Name:
MultiCare Regional Cancer Center - Tacoma
Address:
City:
Middletown
Zip:
45042
Country:
United States
Status:
Recruiting
Facility:
Name:
Toledo Clinic Cancer Center
Address:
City:
Toledo
Zip:
43623
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Facility:
Name:
St. Charles Health System, Inc. DBA St. Charles Medical Center
Address:
City:
Bend
Zip:
97701
Country:
United States
Status:
Recruiting
Facility:
Name:
Samaritan Hospital
Address:
City:
Corvallis
Zip:
97330
Country:
United States
Status:
Recruiting
Facility:
Name:
Willamette Valley Cancer Institute and Research Center
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Facility:
Name:
Asante Rogue Regional Medical Center
Address:
City:
Medford
Zip:
97504
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Cancer Institute - Oncology Clinical Trials
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Facility:
Name:
Saint Luke's University Hospital
Address:
City:
Bethlehem
Zip:
18015
Country:
United States
Status:
Recruiting
Facility:
Name:
Lancaster General Health
Address:
City:
Lancaster
Zip:
17601
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pennsylvania Abramson Cancer Center
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
Guthrie Clinical Research
Address:
City:
Sayre
Zip:
18840
Country:
United States
Status:
Recruiting
Facility:
Name:
Reading Hospital and Medical Center
Address:
City:
West Reading
Zip:
19611
Country:
United States
Status:
Recruiting
Facility:
Name:
Lankenau Medical Center
Address:
City:
Wynnewood
Zip:
19106
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer Care Associates of York
Address:
City:
York
Zip:
17403
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Health
Address:
City:
Providence
Zip:
02905
Country:
United States
Status:
Recruiting
Facility:
Name:
Medical University of South Carolina
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Facility:
Name:
Spartanburg Medical Center
Address:
City:
Spartanburg
Zip:
29303
Country:
United States
Status:
Recruiting
Facility:
Name:
Monument Health Cancer Care Institute
Address:
City:
Rapid City
Zip:
57701
Country:
United States
Status:
Recruiting
Facility:
Name:
Avera Cancer Institute
Address:
City:
Sioux Falls
Zip:
57105
Country:
United States
Status:
Recruiting
Facility:
Name:
Ballad Health Cancer Care - Kingsport
Address:
City:
Kingsport
Zip:
37660
Country:
United States
Status:
Recruiting
Facility:
Name:
Center for Biomedical Research, LLC
Address:
City:
Knoxville
Zip:
37909
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Tennessee
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Recruiting
Facility:
Name:
Hendrick Health System
Address:
City:
Abilene
Zip:
79601
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology
Address:
City:
Austin
Zip:
78731
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology
Address:
City:
El Paso
Zip:
79902
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Joe Arrington Cancer Research and Treatment Center
Address:
City:
Lubbock
Zip:
79410
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology
Address:
City:
San Antonio
Zip:
78240
Country:
United States
Status:
Recruiting
Facility:
Name:
Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Virginia
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Commonwealth University Medical Center
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology and Hematology Associates of Southwest Virginia, Inc
Address:
City:
Wytheville
Zip:
24382
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Regional Cancer System
Address:
City:
Lacey
Zip:
98503
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Medical Specialties, PLLC
Address:
City:
Puyallup
Zip:
98373
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Washington
Address:
City:
Renton
Zip:
98055
Country:
United States
Status:
Recruiting
Facility:
Name:
Medical Oncology Associates
Address:
City:
Spokane
Zip:
99208
Country:
United States
Status:
Recruiting
Facility:
Name:
West Virginia University Hospital
Address:
City:
Morgantown
Zip:
26505
Country:
United States
Status:
Recruiting
Facility:
Name:
ThedaCare Regional Cancer Center
Address:
City:
Appleton
Zip:
54911
Country:
United States
Status:
Recruiting
Facility:
Name:
Ascension St. Francis Reiman Cancer Center
Address:
City:
Franklin
Zip:
53132
Country:
United States
Status:
Recruiting
Facility:
Name:
HSHS Saint Mary's Hospital Medical Center - Green Bay
Address:
City:
Green Bay
Zip:
54303
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Wisconsin
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Start date:
December 12, 2022
Completion date:
August 2031
Lead sponsor:
Agency:
Gilead Sciences
Agency class:
Industry
Collaborator:
Agency:
Alliance Foundation Trials, LLC.
Agency class:
Other
Collaborator:
Agency:
NSABP Foundation Inc
Agency class:
Other
Source:
Gilead Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05633654
https://www.gileadclinicaltrials.com/study/?id=GS-US-595-6184
