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)
Triple Negative Breast Cancer, PD-L1 Positive
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer
Eligibility Criteria
Key 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.
Key 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 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.
Sites / Locations
- Alaska Oncology and HematologyRecruiting
- Arizona Oncology Associates, PC-Hope,1845 W Orange Grove RdRecruiting
- Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd.Recruiting
- Arizona Oncology Associates, PC-HopeRecruiting
- Arizona Oncology Associates, PC-Hope,1620 West St. Mary's RoadRecruiting
- Genesis Cancer and Blood InstituteRecruiting
- Genesis Cancer and Blood Institute,1456 Higdon Ferry Road Suite B.Recruiting
- Saint Bernards Medical CenterRecruiting
- Saint Bernards Medical Center,4000 Linwood DriveRecruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200Recruiting
- University of California Irvine Health Chao Family,1640 Newport BlvdRecruiting
- City of HopeRecruiting
- University of California San Diego Moores CancerRecruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200Recruiting
- Cancer and Blood Specialty ClinicRecruiting
- City of Hope,1601 Avocado AveRecruiting
- University of California Irvine Health Chao FamilyRecruiting
- City of Hope,209 Fair Oaks AveRecruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240Recruiting
- Sansum ClinicRecruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600Recruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304Recruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer CenterRecruiting
- St. Jude Hospital Yorba dba St. Joseph Heritage HealthcareRecruiting
- Sansum Clinic,2040 Viborg RoadRecruiting
- City of Hope,5215 Torrance BlvdRecruiting
- Torrance Memorial Physician Network - Cancer CareRecruiting
- City of Hope,1100 San Bernardino RdRecruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100Recruiting
- Rocky Mountain Cancer Centers,1700 South Potomac StreetRecruiting
- Rocky Mountain Cancer CentersRecruiting
- Rocky Mountain Cancer Centers,2312 N. Nevada AvenueRecruiting
- Rocky Mountain Cancer Centers,6031 E. Woodman Rd.Recruiting
- Rocky Mountain Cancer Centers,4700 E. Hale ParkwayRecruiting
- Rocky Mountain Cancer Centers,11750 West 2nd PlaceRecruiting
- Rocky Mountain Cancer Centers,22 West Dry Creek CircleRecruiting
- Rocky Mountain Cancer Centers,10107 Ridge Gate ParkwayRecruiting
- Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210Recruiting
- Rocky Mountain Cancer Centers,3676 Parker BlvdRecruiting
- Rocky Mountain Cancer Centers,525 W. 15th StreetRecruiting
- Rocky Mountain Cancer Centers,8820 Huron StreetRecruiting
- Eastern Connecticut Hematology and Oncology AssociatesRecruiting
- Advent Health Medical GroupRecruiting
- SCRI - Florida Cancer Specialists - North Region R,106 Boston AveRecruiting
- University of Miami - Sylvester Comprehensive Cancer Center,2801 NE 213th StRecruiting
- Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 ARecruiting
- Florida Cancer Specialists,3630 Manatee Avenue WestRecruiting
- Florida Cancer Specialists,5985 Silver Falls RunRecruiting
- SCRI - Florida Cancer Specialists - North Region R,403 S. Kings Ave.Recruiting
- Florida Cancer Specialists,1030 Commerce Creek BlvdRecruiting
- SCRI - Florida Cancer Specialists - North Region R,3280 McMullen Booth RoadRecruiting
- University of Miami - Sylvester Comprehensive Cancer Center,5555 Ponce De Leon BlvdRecruiting
- SCRI - Florida Cancer Specialists - West Palm Beach,224 Memorial Medical Parkway, Suite 300Recruiting
- University of Miami - Sylvester Comprehensive Cancer Center,1192 East Newport Center DriveRecruiting
- Florida Cancer SpecialistsRecruiting
- Florida Cancer Specialists,8981 Colonial Center DriveRecruiting
- Florida Cancer Specialists,8260 Gladiolus DrRecruiting
- SCRI - Florida Cancer Specialists - North Region R,6420 W. Newberry RoadRecruiting
- University of Miami - Sylvester Comprehensive Cancer Center,3850 Hollywood BlvdRecruiting
- SCRI - Florida Cancer Specialists - North Region R,100 Highland AvenueRecruiting
- SCRI - Florida Cancer Specialists - North Region R,521 North Lecanto HighwayRecruiting
- University of Miami - Sylvester Comprehensive Cancer Center,1400 NW 12th AveRecruiting
- University of Miami - Sylvester Comprehensive Cancer CenterRecruiting
- University of Miami - Sylvester Comprehensive Cancer Center,8932 S.W. 97 AveRecruiting
- Florida Cancer Specialists,1100 Goodlette RoadRecruiting
- SCRI - Florida Cancer Specialists - North Region R,4945 SW 49th PlaceRecruiting
- SCRI - Florida Cancer Specialists - North Region R,765 Image WayRecruiting
- Advent Health Medical Group,2501 North Orange AveRecruiting
- SCRI - Florida Cancer Specialists - North Region R,70 W. Gore StreetRecruiting
- University of Miami - Sylvester Comprehensive Cancer Center,8100 SW 10 StreetRecruiting
- Florida Cancer Specialists,22395 Edgewater DriveRecruiting
- SCRI - Florida Cancer Specialists - North Region R,1201 Fifth Avenue NorthRecruiting
- SCRI - Florida Cancer Specialists - North Region RRecruiting
- Florida Cancer Specialists,600 North Cattlemen RoadRecruiting
- Florida Cancer Specialists,1970 Golf StreetRecruiting
- SCRI - Florida Cancer Specialists - North Region R,7154 Medical Center DriveRecruiting
- SCRI - Florida Cancer Specialists - West Palm Beach,301 SE Ocean Blvd, Suite 102Recruiting
- SCRI - Florida Cancer Specialists - North Region R,3402 West Dr. Martin Luther King Jr. BoulevardRecruiting
- SCRI - Florida Cancer Specialists - North Region R,4100 Waterman WayRecruiting
- SCRI - Florida Cancer Specialists - North Region R,1400 US Highway 441 NRecruiting
- SCRI - Florida Cancer Specialists - North Region R,9320 State Road 54Recruiting
- Florida Cancer Specialists,836 Sunset Lake BlvdRecruiting
- SCRI - Florida Cancer Specialists - West Palm Beach,3730 7th Terrace, Suite 101Recruiting
- SCRI - Florida Cancer Specialists - West Palm Beach,1037 S. State Road 7, Bldg B, Suite 303Recruiting
- SCRI - Florida Cancer Specialists - West Palm BeachRecruiting
- SCRI - Florida Cancer Specialists - North Region R,460 N Orlando AveRecruiting
- Northside Hospital,125 King AvenueRecruiting
- Piedmont Cancer Institute - Atlanta,1267 Hwy 54WRecruiting
- Winship Cancer Institute of Emory University,550 Peachtree St NERecruiting
- Piedmont Cancer Institute - AtlantaRecruiting
- Winship Cancer Institute of Emory UniversityRecruiting
- Northside Hospital,5670 Peachtree Dunwoody Rd.Recruiting
- Northside HospitalRecruiting
- Winship Cancer Institute of Emory University,5665 Peachtree Dunwoody RoadRecruiting
- Northside Hospital,308 Deep South Farm Rd, Suite 200Recruiting
- Northside Hospital,228 Riverstone Dr.Recruiting
- Northside Hospital,1505 Northside Blvd, Suite 4600Recruiting
- Northside Hospital,3855 Pleasant Hill Rd., Suite 480Recruiting
- Northside Hospital,308 Coliseum Dr.Recruiting
- Piedmont Cancer Institute - Atlanta,775 Poplar RoadRecruiting
- Piedmont Cancer Institute - Atlanta,1240 Eagles Landing PkwyRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityRecruiting
- University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)Recruiting
- Orchard Healthcare Research Inc,2845 North Sheridan Road, 1st FloorRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1 Kish Hospital DriveRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,10 Health Services DriveRecruiting
- Orchard Healthcare Research Inc,800 Austin Street, Suite 360, East TowerRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,300 Randall RoadRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,304 Randall RoadRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1000 N. Westmoreland RoadRecruiting
- Orchard Healthcare Research IncRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4405 Weaver ParkwayRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4455 Weaver ParkwayRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,25 N Winfield RoadRecruiting
- Regulatory Management Only: TRIO-US Central AdministrationRecruiting
- The University of Kansas Cancer Center,2000 Olathe BlvdRecruiting
- The University of Kansas Cancer Center,12200 W. 110th StreetRecruiting
- The University of Kansas Cancer Center,10710 Nall AvenueRecruiting
- The University of Kansas Cancer Center,10730 Nall AvenueRecruiting
- The University of Kansas Cancer CenterRecruiting
- Norton Cancer Institute - Saint Matthews,234 E. Gray StrretRecruiting
- Norton Cancer Institute - Saint Matthews,676 S. Floyd StreetRecruiting
- Norton Cancer Institute - Saint MatthewsRecruiting
- Norton Cancer Institute - Saint Matthews,4955 Norton Healthcare BlvdRecruiting
- Hematology Oncology Clinic - Baton RougeRecruiting
- Hematology Oncology Clinic - Baton Rouge,1673 E Mount Please DriveRecruiting
- Cancer Institute Ascension Saint AgnesRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Massachusetts General HospitalRecruiting
- Massachusetts General Hospital,102 Endicott StreetRecruiting
- Massachusetts General Hospital,2014 Washington StRecruiting
- Ascension St. John HospitalRecruiting
- Ascension Providence Hospital Southfield Cancer CenterRecruiting
- Mayo ClinicRecruiting
- The West Clinic, PLLC dba West Cancer Center,7668 Airways BlvdRecruiting
- The University of Kansas Cancer Center,2750 Clay Edwards DriveRecruiting
- The University of Kansas Cancer Center,8700 North Green Hills RoadRecruiting
- The University of Kansas Cancer Center,4881 N.E. Goodview CircleRecruiting
- Nebraska Cancer Specialists,2730 W. Faidley AveRecruiting
- Nebraska Cancer Specialists,8303 Dodge StreetRecruiting
- Nebraska Cancer SpecialistsRecruiting
- Nebraska Cancer Specialists,611 Fenwick DrRecruiting
- Comprehensive Cancer Centers of Nevada - Central V,10001 S. Eastern Avenue, Suite 108Recruiting
- Comprehensive Cancer Centers of Nevada - Central V,2460 W. Horizon Ridge ParkwayRecruiting
- Comprehensive Cancer Centers of Nevada - Central V,1501 Wigwam Parkway, Suite 1300Recruiting
- Comprehensive Cancer Centers of Nevada - Central V,653 North Town Center Drive, Suite 402Recruiting
- Comprehensive Cancer Centers of Nevada - Central V,9280 W. Sunset Road Suite 100Recruiting
- Comprehensive Cancer Centers of Nevada - Central V,7445 Peak DriveRecruiting
- Comprehensive Cancer Centers of Nevada - Central VRecruiting
- Summit Medical Group,1 Diamond Hill RoadRecruiting
- Regional Cancer Care Associates - East BrunswickRecruiting
- Summit Medical GroupRecruiting
- John Theurer Cancer CenterRecruiting
- Rutgers Cancer Institute of New Jersey,2575 Klockner RoadRecruiting
- Rutgers Cancer Institute of New Jersey,414 Grand StreetRecruiting
- Rutgers Cancer Institute of New Jersey,600 River AvenueRecruiting
- Rutgers Cancer Institute of New Jersey,94 Old Short Hills RoadRecruiting
- Rutgers Cancer Institute of New Jersey,300 Second AveRecruiting
- Regional Cancer Care Associates - East Brunswick,9 Centre DriveRecruiting
- Regional Cancer Care Associates - East Brunswick,34-36 Progress StreetRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Rutgers Cancer Institute of New Jersey,150 Bergen St.Recruiting
- Rutgers Cancer Institute of New Jersey,201 Lyons AvenueRecruiting
- Regional Cancer Care Associates - East Brunswick,75 Veronica AvenueRecruiting
- Rutgers Cancer Institute of New Jersey,110 Rehill AveRecruiting
- Rutgers Cancer Institute of New Jersey,99 Highway 37 WestRecruiting
- Rutgers Cancer Institute of New Jersey,100 State Route 36Recruiting
- New York Cancer & Blood Specialists - Port Jeffers,72 East Main St.Recruiting
- New York Cancer & Blood Specialists - Port Jeffers,12 East 86th St, Suite 4Recruiting
- Montefiore Medical Center - Montefiore Medical ParkRecruiting
- New York Cancer & Blood Specialists - Port Jeffers,2330 Eastchester Road, Suite 360Recruiting
- Perlmutter Cancer Center - Manhattan - 34th Street,259 First StreetRecruiting
- New York Cancer & Blood Specialists - Port Jeffers,1 Delaware Dr.Recruiting
- Perlmutter Cancer Center - Manhattan - 34th StreetRecruiting
- NYP/Columbia Univeresity Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
- New York Cancer & Blood Specialists - Port Jeffers,365 East Main St.Recruiting
- New York Cancer & Blood Specialists - Port Jeffers,49 Rte. 347, Newconset HwyRecruiting
- New York Cancer & Blood Specialists - Port JeffersRecruiting
- New York Cancer & Blood Specialists - Port Jeffers,1500 Rte, 112, Building 4Recruiting
- New York Cancer & Blood Specialists - Port Jeffers,750 Old County Rd. Suite 4Recruiting
- The Ohio State University Wexner Medical Center Clinical LaboratoriesRecruiting
- Zangmeister Cancer CenterRecruiting
- Northwest Cancer Specialists, PC,5050 NE Hoyt St.Recruiting
- Northwest Cancer Specialists, PC,265 N. BroadwayRecruiting
- Northwest Cancer Specialists, PCRecruiting
- Magee-Womens Hospital of UPMC,200 Oxford DriveRecruiting
- Magee-Womens Hospital of UPMC,3 St. Francis WayRecruiting
- Magee-Womens Hospital of UPMC,2500 West 12th StreetRecruiting
- Magee-Womens Hospital of UPMC,201 State Street, 6 MainRecruiting
- Magee-Womens Hospital of UPMC,200 Village DriveRecruiting
- Magee-Womens Hospital of UPMC,4300 Londonberry RoadRecruiting
- Magee-Womens Hospital of UPMC,400 Oxford DriveRecruiting
- University of Pennsylvania Abramson Cancer CenterRecruiting
- Magee-Womens Hospital of UPMCRecruiting
- Magee-Womens Hospital of UPMC,5115 Centre AvenueRecruiting
- Magee-Womens Hospital of UPMC,9100 Babcock BoulevardRecruiting
- Magee-Womens Hospital of UPMC,100 Fairfield DrRecruiting
- Magee-Womens Hospital of UPMC,470 Johnson RoadRecruiting
- Magee-Womens Hospital of UPMC,1703 Innovation DriveRecruiting
- Rhode Island HospitalRecruiting
- Rhode Island Hospital,164 Summit Ave, Fain 275ARecruiting
- Tennessee Oncology, PLLC,103 Natchez Park DriveRecruiting
- Tennessee Oncology, PLLC,4488 Carothers ParkwayRecruiting
- Tennessee Oncology, PLLC,225 Big Station Camp BlvdRecruiting
- The West Clinic, PLLC dba West Cancer CenterRecruiting
- Tennessee Oncology, PLLC,353 New Shackle Island RoadRecruiting
- Tennessee Oncology, PLLC,5653 First Blvd.Recruiting
- Tennessee Oncology, PLLC,103 Physicians WayRecruiting
- Tennessee Oncology, PLLC,1840 Medical Center ParkwayRecruiting
- Tennessee Oncology, PLLC,2004 Hayes StreetRecruiting
- Tennessee Oncology, PLLCRecruiting
- Tennessee Oncology, PLLC,4220 Harding RdRecruiting
- Tennessee Oncology, PLLC,3443 Dickerson RoadRecruiting
- Tennessee Oncology, PLLC,397 Wallace RoadRecruiting
- Tennessee Oncology, PLLC,120 Frank Martin RoadRecruiting
- Tennessee Oncology, PLLC,300 Stonecrest BlvdRecruiting
- The Center for Cancer and Blood Disorders - Magnolia,515 W. Mayfield Rd.Recruiting
- Texas Oncology-Austin,901 West 38th StreetRecruiting
- Texas Oncology-AustinRecruiting
- Texas Oncology-Austin,4101 James Casey, Suite 100Recruiting
- The Center for Cancer and Blood Disorders - Magnolia,11805 South FreewayRecruiting
- Texas Oncology-Baylor Charles A. Sammons Cancer CenterRecruiting
- Texas Oncology-DenisonRecruiting
- The Center for Cancer and Blood Disorders - MagnoliaRecruiting
- Oncology Consultants,1631 North Loop WestRecruiting
- Oncology Consultants,925 GessnerRecruiting
- Oncology ConsultantsRecruiting
- University of Texas MD Anderson Cancer Center,1155 Pressler StRecruiting
- University of Texas MD Anderson Cancer CenterRecruiting
- Mays Cancer CenterRecruiting
- The Center for Cancer and Blood Disorders - Magnolia,920 Santa Fe DriveRecruiting
- Huntsman Cancer Institute, University of Utah,165 North University AvenueRecruiting
- Huntsman Cancer Institute, University of Utah,1280 E. Stringham AvenueRecruiting
- Huntsman Cancer Institute, University of UtahRecruiting
- Huntsman Cancer Institute, University of Utah,5126 West Daybreak ParkwayRecruiting
- Virginia Oncology Associates,744 N. Battlefield BlvdRecruiting
- Virginia Cancer Institute,7501 Right Flank RoadRecruiting
- Virginia Oncology Associates,1051 Loftis Blvd Suite 100Recruiting
- Virginia Oncology AssociatesRecruiting
- Virginia Cancer Institute,210 Medical Park BoulevardRecruiting
- Virginia Cancer Institute,1401 Johnston-Willis DriveRecruiting
- Virginia Cancer InstituteRecruiting
- Virginia Oncology Associates,1950 Glenn Mitchell DriveRecruiting
- Northwest Cancer Specialists, PC,210 SE 136th AvenueRecruiting
- Hospital Británico de Buenos AiresRecruiting
- Instituto de Oncología Ángel H. RoffoRecruiting
- Fundacion CORI para la Investigacioy y Prevención del CancerRecruiting
- Instituto de Oncologia de RosarioRecruiting
- CAIPO Centro Para La Atención Integral Del PacientRecruiting
- Clinica ViedmaRecruiting
- Border Medical OncologyRecruiting
- Saint George Hospital - AustraliaRecruiting
- Mater Hospital - North SydneyRecruiting
- GenesisCare - North ShoreRecruiting
- Mater Misericordiae Limited and Mater Research LimitedRecruiting
- Princess Alexandra HospitalRecruiting
- Cancer Research SA (CRSA)Recruiting
- Icon Cancer Centre HobartRecruiting
- Monash Medical CentreRecruiting
- Austin HospitalRecruiting
- Peter MacCallum Cancer CentreRecruiting
- Breast Cancer Research Center - Western AustraliaRecruiting
- Medizinische Universität InnsbruckRecruiting
- Ordensklinikum Linz GmbH Barmherzige SchwesternRecruiting
- Landeskrankenhaus SalzburgRecruiting
- Universitätsklinikum Sankt PöltenRecruiting
- Medizinische Universität WienRecruiting
- Institut Jules BordetRecruiting
- Algemeen Ziekenhuis KlinaRecruiting
- Cliniques Universitaires Saint-LucRecruiting
- Universitair Ziekenhuis BrusselRecruiting
- Grand Hopital de Charleroi - Notre DameRecruiting
- Universitair Ziekenhuis GentRecruiting
- UZ LeuvenRecruiting
- Centre Hospitalier Universitaire Université CatholRecruiting
- Hospital Araújo Jorge - Associacao de Combate ao Cancer em Goias - ACCGRecruiting
- Centro de Pesquisa Clinica Em Oncologia - ONCOSITERecruiting
- Hospital de Clinicas de Porto Alegre - HCPARecruiting
- Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho - Hospital Amarval CarvalhoRecruiting
- Associacao Hosptialar Moinos de Vento - Hospital Moinhos de VentoRecruiting
- Hospital de Clínicas de Porto AlegreRecruiting
- Hospital Sao Lucas da PUCRSRecruiting
- Instituto Nacional de Câncer - BrazilRecruiting
- Núcleo de Oncologia da BahiaRecruiting
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Centro Universitário FMABCRecruiting
- Real e Benemerita Associacao Portuguesa de Beneficencia - Hospital Beneficencia Portuguesa (BP) - Unidade PaulistaRecruiting
- Clinica de Pesquisas e Centro de Estudos em OncoloRecruiting
- Fundação Pio XII - Hospital de Câncer de BarretosRecruiting
- Nucleo de Pesquisa Clinica da Rede Sao CamiloRecruiting
- Tom Baker Cancer CentreRecruiting
- Cross Cancer InstituteRecruiting
- QEII Health Sciences CentreRecruiting
- Grand River Regional Cancer Centre at Grand River HospitalRecruiting
- London Health Sciences CentreRecruiting
- McGill University Health CentreRecruiting
- Jewish General HospitalRecruiting
- Princess Margaret Cancer Centre - University Health NetworkRecruiting
- Ottawa Hospital - General CampusRecruiting
- Sunnybrook Research InstituteRecruiting
- Mount Sinai HospitalRecruiting
- British Columbia Cancer - VancouverRecruiting
- Oncovida - SantiagoRecruiting
- Clínica IRAMRecruiting
- Centro de Cancer Pontificia Universidad CatolicaRecruiting
- Clínica AlemanaRecruiting
- James Lind Centro de Investigacion del CancerRecruiting
- Masarykuv Onkologicky Ustav, Klinika Komplexni Onkologicke PeceRecruiting
- Fakultní Thomayerova nemocniceRecruiting
- Fakultní Nemocnice Hradec KrálovéRecruiting
- Fakultni nemocnice Olomouc, Onkologicka klinikaRecruiting
- Vseobecna Fakultni Nemocnice v Praze, Onkologicka klinikaRecruiting
- Fakultní Nemocnice Královské Vinohrady, Radioterapeuticka a onkologicka klinikaRecruiting
- Sainte Catherine Institut du Cancer Avignon ProvenceRecruiting
- Centre Hospitalier Régional et Universitaire de BeRecruiting
- Polyclinique Bordeaux Nord AquitaineRecruiting
- Hôpital Morvan, Institut de cancérologieRecruiting
- Centre de Lutte contre le Cancer - François BaclesRecruiting
- Centre Jean PerrinRecruiting
- Centre Leon BerardRecruiting
- Institut Paoli-CalmettesRecruiting
- Institut Régional du Cancer de MontpellierRecruiting
- Centre de Cancérologie du Grand MontpellierRecruiting
- Hôpital Privé du ConfluentRecruiting
- Hospices Civils de Lyon, Hôpital Lyon SudRecruiting
- Centre Armoricain de Radiothérapie, dImagerie MédRecruiting
- Centre Eugène MarquisRecruiting
- Institut Claudius Regaud - IUCT-ORecruiting
- Institut Gustave RoussyRecruiting
- Helios Klinikum Berlin-BuchRecruiting
- : Gynakologisches Zentrum Bonn, Schwerpunkt Gyn. Onkologie,Recruiting
- Marienhospital BottropRecruiting
- Universitätsklinikum Erlangen, Frauen klinikRecruiting
- Kliniken Essen-Mitte - Evangelische Huyssens-StiftRecruiting
- Praxis für interdisziplinäre Onkologie & HämatologRecruiting
- : Universitätsklinikum Hamburg-EppendorfRecruiting
- Facharztzentrum EppendorfRecruiting
- Nationales Centrum für TumorerkrankungenRecruiting
- Klinik Frauenheilkunde, Uniklinik ClO, StudienzentraleRecruiting
- Universitätsklinikum Schleswig-Holstein Institut fur Klinische ChermieRecruiting
- Universitatsklinikum Mannheim GmBH, FrauenklinikRecruiting
- Universitätsklinikum Münster, Bereich Senologie an der klinik fur Frauenheilkunde und GerburtschilfeRecruiting
- EV. Krankenhaus Bethesda - Johanniter GmbH, Station 1 Brustzentrum NiederrheinRecruiting
- Rotkreuzklinikum Munchen FrauenklinikRecruiting
- Klinik und Poliklinik für FrauenheilkundeRecruiting
- Universitatsklinikum TubingenRecruiting
- St. Josefs-Hospital Wiesbaden GmbH, Gynakologie und GeburtshilfeRecruiting
- Department of Medicine, Queen Mary HospitalRecruiting
- Hong Kong Sanatorium and HospitalRecruiting
- Tuen Mun HospitalRecruiting
- Prince of Wales Hospital - Hong KongRecruiting
- Orszagos Onkologiai IntezetRecruiting
- Uzsoki Utcai KórházRecruiting
- Debreceni Egyetem Klinikai KözpontRecruiting
- Petz Aladár Egyetemi Oktató Kórház - Gy?rRecruiting
- Soroka Medical CenterRecruiting
- Rambam Health Care CampusRecruiting
- Shaare Zedek Medical CenterRecruiting
- Hadassah - Hebrew University Medical CenterRecruiting
- Meir Medical CenterRecruiting
- Rabin Medical CenterRecruiting
- Kaplan Medical CenterRecruiting
- Sheba Medical Center Hospital - Tel HashomerRecruiting
- Tel Aviv Sourasky Medical CenterRecruiting
- IRCCS Istituto Tumori "Giovanni Paolo II"Recruiting
- SSD Oncologia Medica Addarii-Zamagni, IRCSS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'OrsolaRecruiting
- UO Oncologia, ASST degli Spedali Civili di BresciaRecruiting
- IRCCS Ospedale Policlinico San MartinoRecruiting
- S.C. Oncologia medica, ASST di LeccoRecruiting
- Presidio Ospedaliero di LuccaRecruiting
- Ospedale San RaffaeleRecruiting
- Fondazione IRCCS - Istituto Nazionale dei TumoriRecruiting
- Centro Ricerca Fase I, Fondazione IRCSS San Gerado dei TintoriRecruiting
- Oncologia Medica Senologica Sperimentale - Istituto Nazionale Tumori IRCCS Fondazione G. PascaleRecruiting
- AOU Maggiore della CaritaRecruiting
- Istituto Oncologico Veneto - IRCCSRecruiting
- S.O.C Oncologia Medica, Nuovo Ospedale di Prato Santo StefanoRecruiting
- Policlinico di RomaRecruiting
- Fondazione Policlinico Universitario Agostino GemeRecruiting
- Azienda Ospedaliera Universitaria Senese - LospedRecruiting
- Aichi Cancer Center HospitalRecruiting
- Tohoku University HospitalRecruiting
- Juntendo University HospitalRecruiting
- Chiba Cancer CenterRecruiting
- Osaka Prefectural Hospital Organization Osaka International Cancer InstituteRecruiting
- NHO Shikoku Cancer CenterRecruiting
- Fukushima Medical University HospitalRecruiting
- Saitama Cancer CenterRecruiting
- Hakuaikai Sagara HospitalRecruiting
- National Cancer Center Hospital EastRecruiting
- The Cancer Institute Hospital of JFCRRecruiting
- Kumamoto University HospitalRecruiting
- Kure Medical Center And Chugoku Cancer CenterRecruiting
- Mie University HospitalRecruiting
- Nagoya University HospitalRecruiting
- Nagoya City University HospitalRecruiting
- Hiroshima City Hiroshima Citizens HospitalRecruiting
- NIigata Cancer Center HospitalRecruiting
- Okayama University HospitalRecruiting
- Gunma Prefectural Cancer CenterRecruiting
- Kyoto University HospitalRecruiting
- Hokkaido Cancer CenterRecruiting
- Shizuoka General HospitalRecruiting
- Shizuoka Cancer CenterRecruiting
- Osaka University HospitalRecruiting
- Showa University HospitalRecruiting
- Kanagawa Cancer CenterRecruiting
- National Cancer Center - KoreaRecruiting
- Seoul National University Bundang HospitalRecruiting
- Severance HospitalRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
- Icaro Investigaciones en Medicina S.A. de C.V.Recruiting
- Cryptex Investigación ClínicaRecruiting
- Centro para el Desarrollo de la MedicinaRecruiting
- Panamerican Clinical Research Mexico - GuadalajaraRecruiting
- Medical Care and Research S.A. de C.VRecruiting
- Avix Investigacion Clinica S.C.Recruiting
- Fucam A.C.Recruiting
- Oncológico PotosinoRecruiting
- FAICIC Clínical ResearchRecruiting
- iBiomed - Investigacion Biomedica para el DesarrolRecruiting
- Amphia Ziekenhuis - Breda LangendijkRecruiting
- Universitair Medisch Centrum GroningenRecruiting
- Medisch Centrum LeeuwardenRecruiting
- Erasmus Medisch CentrumRecruiting
- Narodowy Instytut Onkologii im. Marii SklodowskiejRecruiting
- SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza KoszarowskiegoRecruiting
- Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-CurieRecruiting
- Mazowiecki Szpital Wojewódzki im. w. Jana Pawa II wRecruiting
- Wojskowy Instytut MedycznyRecruiting
- Narodowy Instytut Onkologii im.Marii Marii SklodowskiejsRecruiting
- Ponce Medical School Foundation Inc.Recruiting
- Clinical Research Puerto RicoRecruiting
- Hopelands Cancer CentreRecruiting
- The Medical Oncology Centre of RosebankRecruiting
- University of PretoriaRecruiting
- Hospital Teresa Herrera - Materno InfantilRecruiting
- Hospital Universitari DexeusRecruiting
- Hospital Clinic BarcelonaRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Hospital Universitari Vall d'HebrónRecruiting
- Hospital Universitario de BasurtoRecruiting
- Hospital Universitari Arnau de VilanovaRecruiting
- Hospital General Universitario Gregorio MarañónRecruiting
- MD Anderson Cancer Centre MadridRecruiting
- Hospital Universitario Fundación Jiménez DíazRecruiting
- Hospital Universitario Virgen de la VictoriaRecruiting
- Hospital General Universitario Morales MeseguerRecruiting
- Hospital Unviersitario Virgen del RocioRecruiting
- Hospital Universitario Virgen MacarenaRecruiting
- Hospital Universitario de CanariasRecruiting
- Hospital Clínico Universitario de ValenciaRecruiting
- Kantonsspital BadenRecruiting
- Kantonsspital Baselland - Standort LiestalRecruiting
- Kantonsspital Sankt GallenRecruiting
- Kantonsspital WinterthurRecruiting
- Brust-Zentrum ZurichRecruiting
- Changhua Christian HospitalRecruiting
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
- Taipei Medical University-Shuang Ho HospitalRecruiting
- National Cheng Kung University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Linkou Chang Gung Memorial HospitalRecruiting
- Baskent Uni. Dr Turgut Noyan Uyg. ve Aras. MerkeziRecruiting
- Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve ARecruiting
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalRecruiting
- Memorial Ankara HastanesiRecruiting
- Hacettepe Üniversitesi HastanesiRecruiting
- Trakya Universitesi Tip Fakultesi HastanesiRecruiting
- Istanbul Il Saglik Mudurlugu Goztepe Prof. Dr. SulRecruiting
- Medipol Mega Universite HastanesiRecruiting
- Medicana International Izmir HastanesiRecruiting
- Acibadem Maslak HastanesiRecruiting
- NHS LothianRecruiting
- Clinical Trials Unit Lvl 0 Cancer Research UK Beatson InstituteRecruiting
- Leeds Teaching Hospitals NHS TrustRecruiting
- : Barts Health NHS Trust, St HospitalRecruiting
- Guy's and Saint Thomas' NHS Foundation TrustRecruiting
- University College London HospitalsRecruiting
- Nottingham University Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sacituzumab Govitecan-hziy (SG) + Pembrolizumab
Pembrolizumab + Treatment of Physician's Choice (TPC)
Participants will receive SG 10 mg/kg on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg on Day 1 of 21-day cycles Pembrolizumab will be administered for a maximum of 35 cycles.
Participants will receive pembrolizumab 200 mg on Day 1 of each 21-day cycle (maximum 35 cycles) plus TPC determined prior to randomization from 1 of the 3 allowed regimens: Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of 28-day cycles nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of 28-day cycles Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of 21-day cycles