A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1 (ASCENT-04)

PROTOCOL SUMMARY

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

Participation requirements

Age

18 years +

Sex

All

Healthy Volunteers

Study details

Medical Condition

Triple Negative Breast Cancer, PD-L1 Positive

Gender

N/A

Date

July 2022 - February 2027

Study Type

Interventional

Study Phase

Phase 3

Product

Sacituzumab Govitecan-hziy, Pembrolizumab, Paclitaxel, nab-Paclitaxel, Gemcitabine, Carboplatin

Eligibility information

Inclusion criteria

Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
Individuals presenting with de novo metastatic TNBC are eligible for this study.
TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Demonstrates adequate organ function
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.

Exclusion criteria

Positive serum pregnancy test or women who are lactating.
Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor.
Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment.
Individuals may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible.
Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.
Have an active second malignancy.
Have active serious infection requiring antibiotics.
Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Has an active autoimmune disease that has required systemic treatment in the past 2 years.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (504)

Alaska Oncology and Hematology

Anchorage, Alaska, United States, 99508

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ASCENT-04)

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (504)

Alaska Oncology and Hematology

Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd

Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd.

Arizona Oncology Associates, PC-Hope

Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road

Genesis Cancer and Blood Institute

Genesis Cancer and Blood Institute,1456 Higdon Ferry Road Suite B.

Saint Bernards Medical Center

Saint Bernards Medical Center,4000 Linwood Drive

University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200

University of California Irvine Health Chao Family,1640 Newport Blvd

City of Hope

University of California San Diego Moores Cancer

University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200

Cancer and Blood Specialty Clinic

City of Hope,1601 Avocado Ave

University of California Irvine Health Chao Family

City of Hope,209 Fair Oaks Ave

University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240

Sansum Clinic

University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600

University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304

University of California Los Angeles - Jonsson Comprehensive Cancer Center

St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare

Sansum Clinic,2040 Viborg Road

City of Hope,5215 Torrance Blvd

Torrance Memorial Physician Network - Cancer Care

City of Hope,1100 San Bernardino Rd

University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100

Rocky Mountain Cancer Centers,1700 South Potomac Street

Rocky Mountain Cancer Centers

Rocky Mountain Cancer Centers,2312 N. Nevada Avenue

Rocky Mountain Cancer Centers,6031 E. Woodman Rd.

Rocky Mountain Cancer Centers,4700 E. Hale Parkway

Rocky Mountain Cancer Centers,11750 West 2nd Place

Rocky Mountain Cancer Centers,22 West Dry Creek Circle

Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway

Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210

Rocky Mountain Cancer Centers,3676 Parker Blvd

Rocky Mountain Cancer Centers,525 W. 15th Street

Rocky Mountain Cancer Centers,8820 Huron Street

Eastern Connecticut Hematology and Oncology Associates

Advent Health Medical Group

SCRI - Florida Cancer Specialists - North Region R,750 Orienta Ave

University of Miami - Sylvester Comprehensive Cancer Center,2801 NE 213th St

Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 A

Florida Cancer Specialists,3630 Manatee Avenue West

Florida Cancer Specialists,5985 Silver Falls Run

SCRI - Florida Cancer Specialists - North Region R,403 S. Kings Ave.

Florida Cancer Specialists,1030 Commerce Creek Blvd

SCRI - Florida Cancer Specialists - North Region R,3280 McMullen Booth Road

University of Miami - Sylvester Comprehensive Cancer Center,5555 Ponce De Leon Blvd

SCRI - Florida Cancer Specialists - West Palm Beach,224 Memorial Medical Parkway, Suite 300

University of Miami - Sylvester Comprehensive Cancer Center,1192 East Newport Center Drive

Florida Cancer Specialists

Florida Cancer Specialists,8981 Colonial Center Drive

Florida Cancer Specialists,8260 Gladiolus Dr

SCRI - Florida Cancer Specialists - North Region R,6420 W. Newberry Road

University of Miami - Sylvester Comprehensive Cancer Center,3850 Hollywood Blvd

SCRI - Florida Cancer Specialists - North Region R,100 Highland Avenue

SCRI - Florida Cancer Specialists - North Region R,521 North Lecanto Highway

University of Miami - Sylvester Comprehensive Cancer Center,1400 NW 12th Ave

University of Miami - Sylvester Comprehensive Cancer Center

University of Miami - Sylvester Comprehensive Cancer Center,8932 S.W. 97 Ave

Florida Cancer Specialists,1100 Goodlette Road

SCRI - Florida Cancer Specialists - North Region R,4945 SW 49th Place

SCRI - Florida Cancer Specialists - North Region R,2824 Enterprise Rd

Advent Health Medical Group,2501 North Orange Ave