A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

July 18, 2023

Primary Completion Date

December 18, 2026

Study Completion Date

December 18, 2026

Conditions
Breast Cancer
Interventions
DRUG

Tobemstomig

Participants will receive intravenous (IV) tobemstomig every 3 weeks (Q3W) until disease progression or until up to 24 months after the first treatment, whichever is sooner.

DRUG

Pembrolizumab

Participants will receive IV pembrolizumab Q3W until disease progression or until up to 24 months after the first treatment, whichever is sooner.

DRUG

Nab-Paclitaxel

Participants will receive IV nab-paclitaxel weekly for 3 weeks, followed by 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.

Trial Locations (38)

41

Oncosalud Sac, Lima

100

National Taiwan Uni Hospital, Taipei

2196

Medical Oncology Centre of Rosebank, Johannesburg

2800

Komarom-Eszergom Varmegyei Szent Borbala Korhaz, Tatabánya

10065

Memorial Sloan-Kettering Cancer Center, New York

20132

Ospedale San Raffaele, Milan

27103

Novant Health Forsyth Medical Center, Winston-Salem

28204

Novant Health Presbyterain Medical Center, Charlotte

28223

Hospital Quiron de Madrid, Pozuelo de Alarcón

30120

Hospital Universitario Virgen de La Arrixaca, El Palmar

45136

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH, Essen

48100

Ospedale Provinciale Santa Maria Delle Croci, Ravenna

57105

Avera Cancer Institute, Sioux Falls

63225

Dres. Andreas Köhler und Roswitha Fuchs, Langen

66278

Centro Médico Zambrano Hellion, Monterrey

68020

Centro de Investigacion Clinica de Oaxaca, Oaxaca City

89075

Universitätsklinikum Ulm Am Michelsberg, Ulm

90720

Cancer Blood and Specialty Clinic, Los Alamitos

5262100

Sheba Medical Center, Ramat Gan

9112001

Hadassah University Hospital - Ein Kerem, Jerusaelm

C1125ABD

Fundación CENIT para la Investigación en Neurociencias, Buenos Aires

Unknown

Sunshine Hospital, St Albans

Instituto Peruano de Oncología y Radioterapia, Lima

74605-070

Hospital Araujo Jorge, Goiânia

50040-000

Hospital do Cancer de Pernambuco - HCP, Recife

14784-400

Hospital de Cancer de Barretos, Barretos

01317-001

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo

140 59

Fakultni Thomayerova nemocnice, Praha 4 - Krc

03100

Health Pharma Professional Research, Mexico City

OncoMed, Mexico City

04001

Centro Medico Monte Carmelo, Arequipa

Lima 34

Instituto Nacional de Enfermedades Neoplasicas, Lima

25-734

?wi?tokrzyskie Centrum Onkologii, Kielce

31-501

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii, Krakow

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY