JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05852691

Studienbeginn:
Juli 2023

Letztes Update:
24.04.2024

Wirkstoff:
Tobemstomig, Pembrolizumab, Nab-Paclitaxel

Indikation (Clinical Trials):
Breast Neoplasms, Triple Negative Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: CO44194 https://forpatients.roche.com/
Kontakt:
Phone: 888-662-6728
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen

Studienlocations
(3 von 71)

Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
73730 Esslingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
79110 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
30625 Hannover
(Niedersachsen)
GermanyZurückgezogen» Google-Maps

InVO - Institut für Versorgungsforschung in der Onkologie GbR
56068 Koblenz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps

Dres. Andreas Köhler und Roswitha Fuchs
63225 Langen
(Hessen)
GermanyRekrutierend» Google-Maps

Onkologische Schwerpunktpraxis Lübeck
23562 Lübeck
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps

Cancer Blood and Specialty Clinic
90720 Los Alamitos
United StatesRekrutierend» Google-Maps

Lawrence J. Ellison Institute for Transformative Medicine
90064 Los Angeles
United StatesRekrutierend» Google-Maps

UCSF Comprehensive Cancer Ctr
94158 San Francisco
United StatesRekrutierend» Google-Maps

Cedars Sinai Outpatient Cancer Center
90048 West Hollywood
United StatesRekrutierend» Google-Maps

Mercy Medical Center
21202 Baltimore
United StatesRekrutierend» Google-Maps

Frederick Health Hospital
21701 Frederick
United StatesRekrutierend» Google-Maps

Novant Health Presbyterain Medical Center
28204 Charlotte
United StatesRekrutierend» Google-Maps

Novant Health Forsyth Medical Center
27103 Winston-Salem
United StatesRekrutierend» Google-Maps

Providence Portland Medical Center
97213 Portland
United StatesRekrutierend» Google-Maps

Providence Oncology and Hematology Care Clinic - Westside
97225 Portland
United StatesRekrutierend» Google-Maps

Avera Cancer Institute
57105 Sioux Falls
United StatesRekrutierend» Google-Maps

Swedish Cancer Inst.
98104 Seattle
United StatesRekrutierend» Google-Maps

Fundación CENIT para la Investigación en Neurociencias
C1125ABD Buenos Aires
ArgentinaRekrutierend» Google-Maps

Cemic; Oncologia Clinica
C1431FWN Buenos Aires
ArgentinaRekrutierend» Google-Maps

Centro Oncologico Korben
C1426AGE Caba
ArgentinaRekrutierend» Google-Maps

Centro Oncologico Riojano Integral (CORI)
F5300COE La Rioja
ArgentinaRekrutierend» Google-Maps

Sanatorio Parque de Rosario
S2000DSV Rosario
ArgentinaRekrutierend» Google-Maps

Hospital Provincial del Centenario
S2002KDS Rosario
ArgentinaRekrutierend» Google-Maps

ICON Cancer Care Adelaide
5037 Kurralta Park
AustraliaRekrutierend» Google-Maps

Sunshine Hospital; Oncology Research
St Albans
AustraliaAktiv, nicht rekrutierend» Google-Maps

Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
6149 Bull Creek
AustraliaRekrutierend» Google-Maps

Hospital Araujo Jorge; Departamento de Ginecologia E Mama
74605-070 Goiania
BrazilRekrutierend» Google-Maps

Hospital do Cancer de Pernambuco - HCP
50040-000 Recife
BrazilRekrutierend» Google-Maps

Hospital de Amor Amazônia
76834-899 Porto Velho
BrazilRekrutierend» Google-Maps

Hospital Nossa Senhora da Conceicao
90040-373 Porto Alegre
BrazilRekrutierend» Google-Maps

Hospital Sao Lucas - PUCRS
90610-000 Porto Alegre
BrazilRekrutierend» Google-Maps

Hospital de Cancer de Barretos
14784-400 Barretos
BrazilRekrutierend» Google-Maps

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
01317-001 Sao Paulo
BrazilRekrutierend» Google-Maps

Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie
741 01 Novy Jicin
CzechiaRekrutierend» Google-Maps

Fakultni nemocnice Olomouc; Onkologicka klinika
779 00 Olomouc
CzechiaRekrutierend» Google-Maps

Fakultni Thomayerova nemocnice; Onkologicka klinika 1. LF UK a FTN
140 59 Praha 4 - Krc
CzechiaRekrutierend» Google-Maps

Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol
150 06 Praha 5
CzechiaRekrutierend» Google-Maps

Aalborg Universitetshospital; Onkologisk Afdeling
9000 Aalborg
DenmarkRekrutierend» Google-Maps

Rigshospitalet; Onkologisk Klinik
2100 København Ø
DenmarkRekrutierend» Google-Maps

Odense Universitetshospital, Onkologisk Afdeling R
5000 Odense C
DenmarkRekrutierend» Google-Maps

Hadassah University Hospital - Ein Kerem; Oncology
9112001 Jerusalem
IsraelRekrutierend» Google-Maps

Sheba Medical Center
5262100 Ramat Gan
IsraelRekrutierend» Google-Maps

Sourasky / Ichilov Hospital; Dept. of Oncology
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps

Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Gangnam Severance Hospital, Yonsei University Health System
06273 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Health Pharma Professional Research
03100 Cdmx
MexicoRekrutierend» Google-Maps

OncoMed; Supportive Care
03100 Ciudad de México
MexicoRekrutierend» Google-Maps

Centro de Investigacion Clinica de Oaxaca
68020 Oaxaca de Juárez
MexicoRekrutierend» Google-Maps

Centro Medico Monte Carmelo
04001 Arequipa
PeruRekrutierend» Google-Maps

Oncosalud Sac; Oncología
41 Lima
PeruRekrutierend» Google-Maps

Instituto Nacional de Enfermedades Neoplasicas
Lima 34 Lima
PeruRekrutierend» Google-Maps

Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
85-796 Bydgoszcz
PolandRekrutierend» Google-Maps

?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii
25-734 Kielce
PolandRekrutierend» Google-Maps

Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
75-581 Koszalin
PolandRekrutierend» Google-Maps

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
30-688 Kraków
PolandRekrutierend» Google-Maps

Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
02-781 Warszawa
PolandRekrutierend» Google-Maps

Medical Oncology Centre of Rosebank; Oncology
2196 Johannesburg
South AfricaRekrutierend» Google-Maps

Cancercare
6045 Port Elizabeth
South AfricaRekrutierend» Google-Maps

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps

Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
30120 El Palmar
SpainRekrutierend» Google-Maps

Complejo Hospitalario de Navarra; Servicio de Oncologia
31008 Pamplona
SpainRekrutierend» Google-Maps

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
28050 Madrid
SpainRekrutierend» Google-Maps

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
29010 Malaga
SpainRekrutierend» Google-Maps

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
46010 Valencia
SpainRekrutierend» Google-Maps

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
11259 Taipei City
TaiwanRekrutierend» Google-Maps

VETERANS GENERAL HOSPITAL; Department of General Surgery
00112 Taipei
TaiwanRekrutierend» Google-Maps

National Taiwan Uni Hospital; Dept of Oncology
100 Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps

Chang Gung Memorial Hosipital at Linkou
333 Taoyuan City
TaiwanRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Prior allogeneic stem cell or solid organ transplantation

- Any other disease, metabolic dysfunction, physical examination finding, or clinical

laboratory finding that contraindicates the use of an investigational drug, may affect

the interpretation of the results, or may render the participant at high risk from

treatment complications

- Treatment with a live, attenuated vaccine within 28 days prior to initiation of study

treatment

- Treatment with investigational therapy within 28 days prior to initiation of study

treatment

- Prior treatment with CD137 agonists or anti-CTLA therapeutic antibodies or an

anti-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 is

longer) prior to initiation of study treatment

- Treatment with systemic corticosteroids or other systemic immunosuppressive

medications (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 humanized antibodies

or fusion proteins

- Known hypersensitivity to Chinese hamster ovary cell products or to any component of

the tobemstomig or pembrolizumab formulation

- Known allergy or hypersensitivity to any component of the to nab-paclitaxel

formulation

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) (Time Frame - From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months))

Secondary outcome:

1. Objective Response Rate (ORR) (Time Frame - Two consecutive occasions at least 4 weeks apart (up to approximately 24 months))

2. Duration of Response (DOR) (Time Frame - 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))

3. Overall Survival (OS) (Time Frame - From randomization to death from any cause (up to approximately 24 months))

4. PFS rate at 12 months (Time Frame - 12 months after randomization)

5. OS rate at 12 months (Time Frame - 12 months after randomization)

6. Serum Concentration of Tobemstomig (Time Frame - Up to approximately 24 months)

7. Incidence of Anti-Drug Antibodies (ADAs) to Tobemstomig (Time Frame - Up to approximately 24 months)

Studien-Arme

Experimental: Arm A
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.
Active Comparator: Arm B
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.

Geprüfte Regime

Tobemstomig (RO7247669):
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.
Pembrolizumab:
Participants will receive IV pembrolizumab Q3W until disease progression or until up to 24 months after the first treatment, whichever is sooner.
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.

Quelle: ClinicalTrials.gov

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"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"

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