Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202405736542144 Date of Approval: 14/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A 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_
Official scientific 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_
Brief summary describing the background and objectives of the trial Breast cancer is the most frequently diagnosed cancer among women, and the leading cause of cancer-related deaths in women worldwide. TNBC accounts for 12% - 20% of newly diagnosed breast cancer cases. TNBC is characterized immunohistologically by the lack of expression of hormonal estrogen receptor (ER) and progesterone receptor (PgR), and lack of overexpression and/or amplification of the human epidermal growth factor receptor 2 (HER2)/neuraminidase (NEU) gene. Compared with other breast cancer subtypes, TNBC tumors are generally larger in size, more poorly differentiated, have more extensive lymph node involvement at diagnosis, and exhibit an invasive phenotype. Patients with TNBC have a higher risk of both local and distant recurrence, and metastases are more likely to occur in visceral organs and the brain, rather than bone, when compared with patients with other breast cancers. Patients with metastatic TNBC have relatively poorer outcomes. 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).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/06/2024
Actual trial start date
Anticipated date of last follow up 28/02/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tobemstomig plus Nabpaclitaxel 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. 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. 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. 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. 80
Control Group Pembrolizumab plus Nabpaclitaxel 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. 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. 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. 80 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 (sym 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/04/2024 University of Ibadan University College Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
College of Medicine, University of lbadan, Queen Elizabeth II Road Ibadan Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 Outcome Objective Response Rate (ORR) Two consecutive occasions at least 4 weeks apart, up to approximately 24 months
Secondary Outcome 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
Secondary Outcome Overall Survival (OS) From randomization to death from any cause, up to approximately 24 months
Secondary Outcome PFS rate at 12 months 12 months after randomization
Secondary Outcome OS rate at 12 months 12 months after randomization
Secondary Outcome Serum Concentration of Tobemstomig Up to approximately 24 months
Secondary Outcome Incidence of Anti-Drug Antibodies (ADAs) to Tobemstomig Up to approximately 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Marcelle Ruth Cancer Center and Specialist Hospital Plot 1192D Olubosi Close, Victoria Island Lagos 101241 Nigeria
University College Hospital Ibadan Queen Elizabeth II Road Agodi Ibadan 200212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Hoffmann La Roche 2nd Floor 48/50 Isaac John Street, Ikeja GRA Lagos 100271 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hoffmann La Roche 2nd Floor 48/50 Isaac John Street, Ikeja GRA Lagos 100271 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Terver Akindigh terver.akindigh@roche.com +2348137328046 2nd Floor 48/50 Isaac John Street, Ikeja GRA
City Postal code Country Position/Affiliation
Lagos 100271 Nigeria Clinical Operations Lead
Role Name Email Phone Street address
Scientific Enquiries Bolarinwa Oyedeji bolarinwa.oyedeji@roche.com +2348056292228 2nd Floor 48/50 Isaac John Street, Ikeja GRA
City Postal code Country Position/Affiliation
Lagos 100271 Nigeria Country Medical Director Nigeria
Role Name Email Phone Street address
Principal Investigator Atara Ntekim kimata2000@hotmail.com +2348023059292 University College Hospital Ibadan, Queen Elizabeth II Road, Agodi
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Consultant Clinical Radiation Oncologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan description: -Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study 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). Clinical Study Report Roche commits to submit a manuscript to a peer-reviewed journal reporting primary clinical trials results no later than 18 months after the first product approval or decision to discontinue development of the product. Available studies are listed and available on the Vivli platform. Data requestors should use the Vivli data request form to request companies data Package(s). If approved requestors will need to sign a Data Use Agreement and the anonymized data will be shared in the Vivli secure research environment.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://vivli.org/ourmember/roche/ No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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