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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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tobemstomig
Pembrolizumab
Nab-Paclitaxel
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Blood and Specialty ClinicRecruiting
  • Mercy Medical CenterRecruiting
  • Providence Portland Medical CenterRecruiting
  • Fundación CENIT para la Investigación en Neurociencias
  • Cemic; Oncologia ClinicaRecruiting
  • Centro Oncologico KorbenRecruiting
  • Centro Oncologico Riojano Integral (CORI)Recruiting
  • Hospital Provincial del CentenarioRecruiting
  • ICON Cancer Care AdelaideRecruiting
  • Sunshine Hospital; Oncology ResearchRecruiting
  • Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials UnitRecruiting
  • Hospital Araujo Jorge; Departamento de Ginecologia E MamaRecruiting
  • Hospital do Cancer de Pernambuco - HCPRecruiting
  • Hospital de Amor AmazôniaRecruiting
  • Hospital Sao Lucas - PUCRSRecruiting
  • Hospital de Cancer de BarretosRecruiting
  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria LtdaRecruiting
  • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
  • Hadassah Ein Karem Hospital; Oncology DeptRecruiting
  • Sheba Medical CenterRecruiting
  • Sourasky / Ichilov Hospital; Dept. of OncologyRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Gangnam Severance Hospital, Yonsei University Health SystemRecruiting
  • Samsung Medical CenterRecruiting
  • Health Pharma Professional ResearchRecruiting
  • OncoMed; Supportive CareRecruiting
  • Centro de Investigacion Clinica de OaxacaRecruiting
  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-OncologyRecruiting
  • National Taiwan Uni Hospital; Dept of OncologyRecruiting
  • Chang Gung Memorial Hosipital at LinkouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

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 treatment discontinuation.

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 treatment discontinuation.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)

Secondary Outcome Measures

Objective Response Rate (ORR)
Duration of Response (DOR)
Overall Survival (OS)
PFS rate at 12 months
OS rate at 12 months
Serum Concentration of Tobemstomig
Incidence of Anti-Drug Antibodies (ADAs) to Tobemstomig

Full Information

First Posted
May 2, 2023
Last Updated
October 17, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05852691
Brief Title
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
Official Title
A Phase II, Multicenter, Randomized, Double-Blind Study of Tobemstomig/RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2023 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
February 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
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 treatment discontinuation.
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
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 treatment discontinuation.
Intervention Type
Drug
Intervention Name(s)
Tobemstomig
Other Intervention Name(s)
RO7247669
Intervention Description
Participants will receive intravenous (IV) tobemstomig every 3 weeks (Q3W) until disease progression or treatment discontinuation.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Participants will receive IV pembrolizumab Q3W until disease progression or treatment discontinuation.
Intervention Type
Drug
Intervention Name(s)
Nab-Paclitaxel
Intervention Description
Participants will receive IV nab-paclitaxel weekly for 3 weeks, followed by 1 week off, until disease progression or treatment discontinuation.
Primary Outcome Measure Information:
Title
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 30 months)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
Two consecutive occasions at least 4 weeks apart (up to approximately 30 months)
Title
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 30 months)
Title
Overall Survival (OS)
Time Frame
From randomization to death from any cause (up to approximately 30 months)
Title
PFS rate at 12 months
Time Frame
12 months after randomization
Title
OS rate at 12 months
Time Frame
12 months after randomization
Title
Serum Concentration of Tobemstomig
Time Frame
Up to approximately 30 months
Title
Incidence of Anti-Drug Antibodies (ADAs) to Tobemstomig
Time Frame
Up to approximately 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: CO44194 https://forpatients.roche.com/
Phone
888-662-6728
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Blood and Specialty Clinic
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Cemic; Oncologia Clinica
City
Buenos Aires
ZIP/Postal Code
C1431FWN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Oncologico Korben
City
Caba
ZIP/Postal Code
C1426AGE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Oncologico Riojano Integral (CORI)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Provincial del Centenario
City
Rosario
ZIP/Postal Code
S2002KDS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
ICON Cancer Care Adelaide
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sunshine Hospital; Oncology Research
City
St Albans
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
City
Bull Creek
State/Province
Western Australia
ZIP/Postal Code
6149
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-070
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital do Cancer de Pernambuco - HCP
City
Recife
State/Province
PE
ZIP/Postal Code
50040-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Amor Amazônia
City
Porto Velho
State/Province
RO
ZIP/Postal Code
76834-899
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Hadassah Ein Karem Hospital; Oncology Dept
City
Jerusalem
ZIP/Postal Code
9112000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sourasky / Ichilov Hospital; Dept. of Oncology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Health Pharma Professional Research
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
OncoMed; Supportive Care
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion Clinica de Oaxaca
City
Oaxaca de Juárez
State/Province
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
City
Taipei City
ZIP/Postal Code
11259
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan Uni Hospital; Dept of Oncology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hosipital at Linkou
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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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