Phase
Condition
Breast Cancer
Cancer
Treatment
Tobemstomig
RO7247669
Nab-Paclitaxel
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Metastatic or locally advanced unresectable, histologically documentedtriple-negative breast cancer (TNBC) (absence of HER2-over-expression, ER, and PgRexpression by local assessment)
HER2-low-status
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
If metastatic disease (Stage IV), measurable disease outside of the bone
No prior systemic therapy for metastatic or locally advanced unresectable TNBC
Tumor PD-L1 expression as documented through central testing of a representativetumor tissue specimen
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Adequate hematologic and end-organ function
Negative HIV test at screening, with the following exception: individuals with apositive HIV test at screening are eligible provided they are stable onanti-retroviral therapy, have a CD4 count ≥ 200/uL, and have an undetectable viralload
Negative hepatitis B surface antigen (HBsAg) test at screening
Positive hepatitis B surface antibody (HBsAb) test at screening, or a negative HBsAbat screening accompanied by either of the following: negative hepatitis B coreantibody (HBcAb); positive HBcAb test followed by quantitative hepatitis B virus (HBV) DNA < 500 IU/mL
Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCVantibody test followed by a negative HCV RNA test at screening
Adequate cardiovascular function
Exclusion
Exclusion Criteria:
Pregnancy or breastfeeding, or intention of becoming pregnant during the study orwithin 4 months after the final dose of tobemstomig or pembrolizumab, and 6 monthsafter the final dose of nab-paclitaxel
Poor venous access
History of malignancy within 5 years prior to consent, except for the cancer underinvestigation in this study and malignancies with a negligible risk of metastasis ordeath (e.g., 5-year OS rate >90%), such as adequately treated carcinoma in situ ofthe cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinomain situ, or Stage I uterine cancer
Symptomatic, untreated, or actively progressing central nervous system (CNS)metastases
History of leptomeningeal disease
Pleural effusion, pericardial effusion, or ascites requiring recurrent drainageprocedures (once monthly or more frequently)
Hypercalcemia or hypercalcemia that is symptomatic
Active or history of autoimmune disease or immune deficiency, including, but notlimited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupuserythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipidantibody syndrome, Wegener granulomatosis (granulomatosis with polyangiitis),Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitisobliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence ofactive pneumonitis on screening chest computed tomography (CT) scan. History ofradiation pneumonitis in the radiation field (fibrosis) is permitted
Active tuberculosis (TB)
Significant cardiovascular/cerebrovascular disease within 3 months prior to consent
History or presence of an abnormal ECG that is deemed clinically significant
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmiassuch as structural heart disease (e.g., severe left ventricular systolicdysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic orwith ischemia demonstrated by diagnostic testing), clinically significantelectrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), orfamily history of sudden unexplained death or long QT syndrome
Major surgical procedure within 4 weeks prior to initiation of study treatment
Treatment with therapeutic oral or IV antimicrobials (anti-bacterial, anti-fungal,antiviral, anti-parasitic) within 1 week prior to initiation of study treatment
Prior allogeneic stem cell or solid organ transplantation
Any other disease, metabolic dysfunction, physical examination finding, or clinicallaboratory finding that contraindicates the use of an investigational drug, mayaffect the interpretation of the results, or may render the participant at high riskfrom treatment complications
Treatment with a live, attenuated vaccine within 28 days prior to initiation ofstudy treatment
Treatment with investigational therapy within 28 days prior to initiation of studytreatment
Prior treatment with CD137 agonists or anti-CTLA therapeutic antibodies or ananti-LAG3 agent
Treatment with systemic immunostimulatory agents (including, but not limited to,interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever islonger) prior to initiation of study treatment
Treatment with systemic corticosteroids or other systemic immunosuppressivemedications (including, but not limited to, prednisone, dexamethasone,cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents)within 2 weeks prior to initiation of study treatment
History of severe allergic anaphylactic reactions to chimeric or humanizedantibodies or fusion proteins
Known hypersensitivity to Chinese hamster ovary cell products or to any component ofthe tobemstomig or pembrolizumab formulation
Known allergy or hypersensitivity to any component of the to nab-paclitaxelformulation
Study Design
Connect with a study center
CEMIC
Buenos Aires, C1431FWN
ArgentinaSite Not Available
Cemic; Oncologia Clinica
Buenos Aires, C1431FWN
ArgentinaSite Not Available
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, C1125ABD
ArgentinaSite Not Available
Centro Oncologico Korben
Caba, C1426AGE
ArgentinaSite Not Available
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE
ArgentinaSite Not Available
Hospital Provincial del Centenario
Rosario, S2002KDS
ArgentinaSite Not Available
Sanatorio Parque de Rosario
Rosario, S2000KZD
ArgentinaSite Not Available
ICON Cancer Care Adelaide
Kurralta Park, South Australia 5037
AustraliaSite Not Available
Sunshine Hospital
St Albans, Victoria
AustraliaSite Not Available
Sunshine Hospital; Oncology Research
St Albans, Victoria
AustraliaSite Not Available
Fiona Stanley Hospital
Bull Creek, Western Australia 6149
AustraliaSite Not Available
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
Bull Creek, Western Australia 6149
AustraliaSite Not Available
Hospital Sao Rafael - HSR
Salvador, Bahia 41253-190
BrazilSite Not Available
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiania, GO 74605-070
BrazilSite Not Available
Hospital Araujo Jorge
Goiania, Goiás 74605-070
BrazilSite Not Available
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco 50040-000
BrazilSite Not Available
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande Do Sul 91350-200
BrazilSite Not Available
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande Do Sul 90610-000
BrazilSite Not Available
Hospital de Amor Amazônia
Porto Velho, Rondônia 76834-899
BrazilSite Not Available
Hospital de Cancer de Barretos
Barretos, São Paulo 14784-400
BrazilSite Not Available
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
Sao Paulo, São Paulo 01317-001
BrazilSite Not Available
Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie
Novy Jicin, 741 01
CzechiaSite Not Available
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00
CzechiaSite Not Available
Fakultni Thomayerova nemocnice
Praha 4 - Krc, 140 59
CzechiaSite Not Available
Fakultni Thomayerova nemocnice; Onkologicka klinika 1. LF UK a FTN
Praha 4 - Krc, 140 59
CzechiaSite Not Available
Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol
Praha 5, 150 06
CzechiaSite Not Available
Centre Hospitalier Universitaire de Treichville
Abidjan, 01BPV03
Côte D'IvoireSite Not Available
Centre Hospitalier Universitaire de Treichville; Oncologie Médicale - Chirurgie
Abidjan, 01BPV03
Côte D'IvoireSite Not Available
Aalborg Universitetshospital
Aalborg, 9000
DenmarkSite Not Available
Aalborg Universitetshospital; Onkologisk Afdeling
Aalborg, 9000
DenmarkSite Not Available
Rigshospitalet; Onkologisk Klinik
København Ø, 2100
DenmarkSite Not Available
Odense Universitetshospital, Onkologisk Afdeling R
Odense C, 5000
DenmarkSite Not Available
Vejle Sygehus; Onkologisk Afdeling
Vejle, 7100
DenmarkSite Not Available
Klinikum Augsburg; Frauenklinik
Augsburg, 86156
GermanySite Not Available
Das Brustzentrum
Berlin, 12623
GermanySite Not Available
St. Johannes Hospital; Abt. für Hämatologie und Onkologie
Dortmund, 44137
GermanySite Not Available
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
Essen, 45136
GermanySite Not Available
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen, 45136
GermanySite Not Available
Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
Esslingen, 73730
GermanySite Not Available
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg, 79110
GermanySite Not Available
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Hannover, 30625
GermanySite Not Available
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, 69120
GermanySite Not Available
InVO - Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, 56068
GermanySite Not Available
Dres. Andreas Köhler und Roswitha Fuchs
Langen, 63225
GermanySite Not Available
Onkologische Schwerpunktpraxis Lübeck
Lübeck, 23562
GermanySite Not Available
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, 55131
GermanySite Not Available
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, 48153
GermanySite Not Available
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
Münster, 48149
GermanySite Not Available
HELIOS Klinikum Schwerin; Frauenklinik
Schwerin, 19049
GermanySite Not Available
Universitätsklinikum Ulm Am Michelsberg
Ulm, 89075
GermanySite Not Available
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
Ulm, 89075
GermanySite Not Available
Somogy Varmegyei Kaposi Mor Oktato Korhaz; Onkologiai Osztaly
Kaposvár, 7400
HungarySite Not Available
Bács-Kiskun Vármegyei Oktatókórház
Kecskemét, 6000
HungarySite Not Available
Bács-Kiskun Vármegyei Oktatókórház; Onkoradiológiai Központ
Kecskemét, 6000
HungarySite Not Available
B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház; Klin. Onkológiai és Sugárterápiás Centrum
Miskolc, 3526
HungarySite Not Available
Komarom-Eszergom Varmegyei Szent Borbala Korhaz; Onkologiai Osztaly
Tatabanya, 2800
HungarySite Not Available
Komarom-Eszergom Varmegyei Szent Borbala Korhaz
Tatabánya, 2800
HungarySite Not Available
Hadassah University Hospital - Ein Kerem
Jerusaelm, 9112001
IsraelSite Not Available
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, 9112000
IsraelActive - Recruiting
Hadassah University Hospital - Ein Kerem; Oncology
Jerusalem, 9112001
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, 5262100
IsraelSite Not Available
Sourasky / Ichilov Hospital
Tel Aviv, 6423906
IsraelSite Not Available
Sourasky / Ichilov Hospital; Dept. of Oncology
Tel Aviv, 6423906
IsraelSite Not Available
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna 40138
ItalySite Not Available
Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii
Bologna, Emilia-Romagna 40138
ItalySite Not Available
Ospedale Provinciale Santa Maria Delle Croci
Ravenna, Emilia-Romagna 48100
ItalySite Not Available
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
Ravenna, Emilia-Romagna 48100
ItalySite Not Available
RCCS - Centro di Riferimento; Oncologia Medica B
Aviano (PN), Friuli-Venezia Giulia 33081
ItalySite Not Available
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
Milano, Lombardia 20141
ItalySite Not Available
Ospedale San Raffaele
Milano, Lombardia 20132
ItalySite Not Available
Ospedale San Raffaele; Medical Oncology
Milano, Lombardia 20132
ItalySite Not Available
Ospedale S. Giuseppe
Empoli (FI), Toscana 50053
ItalySite Not Available
Ospedale S. Giuseppe; Oncologia
Empoli (FI), Toscana 50053
ItalySite Not Available
Ospedale Civile; Unita Operativa Di Oncologia Medica
Livorno, Toscana 57100
ItalySite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Health Pharma Professional Research
Cdmx, Mexico CITY (federal District) 03100
MexicoSite Not Available
OncoMed
Ciudad de México, Mexico CITY (federal District) 03100
MexicoSite Not Available
OncoMed; Supportive Care
Ciudad de México, Mexico CITY (federal District) 03100
MexicoSite Not Available
Centro Médico Zambrano Hellion
Monterrey, Nuevo LEON 66278
MexicoSite Not Available
Centro de Investigacion Clinica de Oaxaca
Oaxaca de Juárez, Oaxaca 68020
MexicoSite Not Available
Ziekenhuis Gelderse Vallei
EDE, 6716 RP
NetherlandsSite Not Available
Centro Medico Monte Carmelo
Arequipa, 04001
PeruSite Not Available
Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima 34
PeruSite Not Available
Instituto Peruano de Oncología y Radioterapia
Lima,
PeruSite Not Available
Oncosalud Sac
Lima, 41
PeruSite Not Available
Oncosalud Sac; Oncología
Lima, 41
PeruSite Not Available
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz, 85-796
PolandSite Not Available
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
Bydgoszcz, 85-796
PolandSite Not Available
Narodowy Instytut Onkologii Odzia? w Gliwicach
Gliwice, 44-102
PolandSite Not Available
Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi
Gliwice, 44-102
PolandSite Not Available
?wi?tokrzyskie Centrum Onkologii
Kielce, 25-734
PolandSite Not Available
?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii
Kielce, 25-734
PolandSite Not Available
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
Koszalin, 75-581
PolandSite Not Available
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
Kraków, 31-501
PolandSite Not Available
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
Warszawa, 02-781
PolandSite Not Available
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
Warszawa, 02-781
PolandSite Not Available
Medical Oncology Centre of Rosebank
Johannesburg, 2196
South AfricaSite Not Available
Medical Oncology Centre of Rosebank; Oncology
Johannesburg, 2196
South AfricaSite Not Available
Cancercare
Port Elizabeth, 6045
South AfricaSite Not Available
Steve Biko Academic Hospital
Pretoria, 0002
South AfricaSite Not Available
Steve Biko Academic Hospital; Oncology
Pretoria, 0002
South AfricaSite Not Available
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña 15706
SpainSite Not Available
Hospital Quiron de Madrid
Pozuelo de Alarcon, Madrid 28223
SpainSite Not Available
Hospital Quiron de Madrid; Servicio de Oncologia
Pozuelo de Alarcon, Madrid 28223
SpainSite Not Available
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia 30120
SpainSite Not Available
Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
El Palmar, Murcia 30120
SpainSite Not Available
Complejo Hospitalario de Navarra; Servicio de Oncologia
Pamplona, Navarra 31008
SpainSite Not Available
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid, 28050
SpainSite Not Available
Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
Madrid, 28050
SpainSite Not Available
Hospital Clinico Universitario Virgen de la Victoria
Malaga, 29010
SpainSite Not Available
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga, 29010
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla, 41013
SpainSite Not Available
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010
SpainSite Not Available
National Taiwan Uni Hospital
Taipei, 100
TaiwanSite Not Available
National Taiwan Uni Hospital; Dept of Oncology
Taipei, 100
TaiwanSite Not Available
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei, 00112
TaiwanSite Not Available
Veterans General Hospital
Taipei, 00112
TaiwanSite Not Available
Koo Foundation Sun Yat-Sen Cancer Center
Taipei City, 11259
TaiwanSite Not Available
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei City, 11259
TaiwanSite Not Available
Chang Gung Memorial Hosipital at Linkou
Taoyuan City, 333
TaiwanSite Not Available
Cancer Blood and Specialty Clinic
Los Alamitos, California 90720
United StatesSite Not Available
Cedars Sinai Outpatient Cancer Center
Los Angeles, California 90048
United StatesSite Not Available
Ellison Institute of Technology
Los Angeles, California 90064
United StatesSite Not Available
Lawrence J. Ellison Institute for Transformative Medicine
Los Angeles, California 90064
United StatesSite Not Available
UCSF Comprehensive Cancer Ctr
San Francisco, California 94158
United StatesSite Not Available
Providence St Johns Health Center
Santa Monica, California 90404
United StatesSite Not Available
Cedars Sinai Outpatient Cancer Center
West Hollywood, California 90048
United StatesSite Not Available
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Health Lone Tree Medical Center
Lone Tree, Colorado 80124
United StatesSite Not Available
Carle Cancer Center
Urbana, Illinois 61801
United StatesSite Not Available
Mercy Medical Center
Baltimore, Maryland 21202
United StatesSite Not Available
Frederick Health Hospital
Frederick, Maryland 21702
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University; Wash Uni. Sch. Of Med
Saint Louis, Missouri 63110
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Novant Health Presbyterain Medical Center
Charlotte, North Carolina 28204
United StatesSite Not Available
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Providence Oncology and Hematology Care Clinic - Westside
Portland, Oregon 97225
United StatesSite Not Available
Providence Portland Medical Center
Portland, Oregon 97213
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Bon Secours Mercy Health
Midlothian, Virginia 23114
United StatesSite Not Available
Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336-7774
United StatesSite Not Available
Swedish Cancer Inst.
Seattle, Washington 98104
United StatesSite Not Available
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