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

NCT05852691 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: CO44194
• Study Type: interventional
• Target: 83
• Locations: 16 countries
• Sites: 37

Brief Summary

The purpose of this study is to assess the efficacy and safety of a novel immunotherapy candidate, tobemstomig, in combination with nab-paclitaxel, for patients with previously untreated, locally advanced, unresectable or metastatic (Stage IV) programmed death-ligand 1 (PD-L1)-positive triple-negative breast cancer (TNBC).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  Two consecutive occasions at least 4 weeks apart (up to approximately 24 months)

• Duration of Response (DOR)

  From the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

• Overall Survival (OS)

  From randomization to death from any cause (up to approximately 24 months)

Study Arms (2)

Arm A

EXPERIMENTAL

Participants will receive tobemstomig every 3 weeks, plus nab-paclitaxel administered on a repeating schedule of 3 weeks on, 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.

Drug: Tobemstomig; Drug: Nab-Paclitaxel

Arm B

ACTIVE COMPARATOR

Participants will receive pembrolizumab every 3 weeks, plus nab-paclitaxel administered on a repeating schedule of 3 weeks on, 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.

Drug: Pembrolizumab; Drug: Nab-Paclitaxel

Interventions

Tobemstomig DRUG

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.

Also known as: RO7247669

Arm A

Pembrolizumab DRUG

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

Arm B

Nab-Paclitaxel DRUG

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.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic or locally advanced unresectable, histologically documented triple-negative breast cancer (TNBC) (absence of HER2-over-expression, ER, and PgR expression 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 representative tumor 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 a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200/uL, and have an undetectable viral load
• Negative hepatitis B surface antigen (HBsAg) test at screening
• Positive hepatitis B surface antibody (HBsAb) test at screening, or a negative HBsAb at screening accompanied by either of the following: negative hepatitis B core antibody (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 HCV antibody test followed by a negative HCV RNA test at screening
• Adequate cardiovascular function

You may not qualify if:

• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 4 months after the final dose of tobemstomig or pembrolizumab, and 6 months after the final dose of nab-paclitaxel
• Poor venous access
• History of malignancy within 5 years prior to consent, except for the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in 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 drainage procedures (once monthly or more frequently)
• Hypercalcemia or hypercalcemia that is symptomatic
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis (granulomatosis with polyangiitis), Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation 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 dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (37)

Cancer Blood and Specialty Clinic

Los Alamitos, California, 90720, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Novant Health Presbyterain Medical Center

Charlotte, North Carolina, 28204, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Buenos Aires, C1113AAE, Argentina

Location

Sunshine Hospital

St Albans, Victoria, Australia

Location

Hospital Araujo Jorge

Goiânia, Goiás, 74605-070, Brazil

Location

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco, 50040-000, Brazil

Location

Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

São Paulo, São Paulo, 01317-001, Brazil

Location

Fakultni Thomayerova nemocnice

Praha 4 - Krc, 140 59, Czechia

Location

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

Essen, 45136, Germany

Location

Dres. Andreas Köhler und Roswitha Fuchs

Langen, 63225, Germany

Location

Universitätsklinikum Ulm Am Michelsberg

Ulm, 89075, Germany

Location

Komarom-Eszergom Varmegyei Szent Borbala Korhaz

Tatabánya, 2800, Hungary

Location

Hadassah University Hospital - Ein Kerem

Jerusaelm, 9112001, Israel

Location

Sheba Medical Center

Ramat Gan, 5262100, Israel

Location

Ospedale Provinciale Santa Maria Delle Croci

Ravenna, Emilia-Romagna, 48100, Italy

Location

Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District), 03100, Mexico

Location

OncoMed

Mexico City, Mexico CITY (federal District), 03100, Mexico

Location

Centro Médico Zambrano Hellion

Monterrey, Nuevo León, 66278, Mexico

Location

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, Oaxaca, 68020, Mexico

Location

Centro Medico Monte Carmelo

Arequipa, 04001, Peru

Location

Oncosalud Sac

Lima, 41, Peru

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, Lima 34, Peru

Location

Instituto Peruano de Oncología y Radioterapia

Lima, Peru

Location

?wi?tokrzyskie Centrum Onkologii

Kielce, 25-734, Poland

Location

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

Krakow, 31-501, Poland

Location

Medical Oncology Centre of Rosebank

Johannesburg, 2196, South Africa

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, 30120, Spain

Location

National Taiwan Uni Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pembrolizumab; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: July 18, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

AR (1); IL (2); IT (2); HU (1); KR (4); BR (4); ZA (1); ME (4); PE (4); DE (3); CZ (1); TW (1); US (4); ES (2); PL (2); AU (1)