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Trial details
A phase II open label, randomized, three-arm, multicenter study of LAG525 given in combination with spartalizumab (PDR001), or with spartalizumab and carboplatin, or with carboplatin, as first or second line therapy in patients with advanced triple-negative breast cancer
Current status:
Approved
|
Date registered:
03/04/2019
Trial version(s)
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
Current: 20/02/2019
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Main Information
Primary registry identifying number
LBCTR2019020196
Protocol number
CLAG525B2101
MOH registration number
33223/2018
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
LCTR was recently initiated, original file was previously submitted by Paper
Date of registration in national regulatory agency
06/08/2018
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
A phase II open label, randomized, three-arm, multicenter study of LAG525 given in combination with spartalizumab (PDR001), or with spartalizumab and carboplatin, or with carboplatin, as first or second line therapy in patients with advanced triple-negative breast cancer
Acronym
Scientific title
A phase II open label, randomized, three-arm, multicenter study of LAG525 given in combination with spartalizumab (PDR001), or with spartalizumab and carboplatin, or with carboplatin, as first or second line therapy in patients with advanced triple-negative breast cancer
Acronym
Brief summary of the study: English
The purpose of this study is to assess the efficacy, safety, and PK characteristics of the following three combinations: i) LAG525 + spartalizumab; ii) LAG525 + spartalizumab + carboplatin, and iii) LAG525 + carboplatin in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. A thorough biomarker strategy to address key aspects of tumor immunogenicity will be implemented in the study.
Brief summary of the study: Arabic
دراسة مرحلة ثانية مفتوحة اللصاقة وعشوائيّة التوزيع ومتعددة المراكز من ثلاث مجموعات حول دواء LAG525 المعطى بالاشتراك مع دواء سبارتاليزوماب (PDR001) ، أو مع سبارتاليزوماب وكاربوبلاتين، أو مع كاربوبلاتين، كعلاج أساسي أو كعلاج خيار ثانٍ لدى المرضى المصابين بسرطان الثدي الثلاثيّ السلبيّ المتقدّم
Health conditions/problem studied: Specify
Triple Negative Breast Cancer
Interventions: Specify
LAG525/ PDR001/ Carboplatin
Key inclusion and exclusion criteria: Inclusion criteria
1-Patient has advanced (loco-regionally recurrent not amenable to curative therapy or metastatic) breast cancer. 2-Patient must have measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (Tumor lesions previously irradiated or subjected to other loco-regional therapy will only be considered measurable if disease progression at the treated site after completion of therapy is clearly documented) 3-Patient progressed after adjuvant or 1 prior systemic treatment in the metastatic setting. Patients with de novo metastatic disease are eligible if they received 1 prior line of therapy 4-Patient must have received prior systemic treatment that included taxane-based chemotherapy for adjuvant or metastatic disease 5-Patient must have a site of disease amenable to biopsy, and must be willing to undergo a new tumor biopsy at screening and during therapy on this study, the latter if medically feasible. Patients with an available archival tumor tissue do not need to perform a tumor biopsy at screening if patient has not received anti-cancer therapy since the biopsy was taken. 6-Patient has histologically and/or cytologically confirmed diagnosis of advanced TNBC (based on most recently analyzed biopsy, local lab) meeting the following criteria: HER2 negative in situ hybridization test or an IHC status of 0 or 1+, and ER and PR expression is <1 percent as determined by immunohistochemistry (IHC)
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
90
Key inclusion and exclusion criteria: Exclusion criteria
1-Patient has received prior immunotherapy as anticancer treatment such as anti-LAG-3, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody (any line of therapy). 2-Patient received prior neoadjuvant or adjuvant therapy with a platinum agent or mitomycin and experienced recurrence within 12 months after the end of the platinum-based or mitomycin containing therapy or received Platinum or mitomycin for metastatic disease 3-Patient has had major surgery within 14 days prior to starting study treatment or has not recovered to grade 1 or less from major side effects. 4-Patient with presence of CTCAE grade 2 toxicity or higher due to prior cancer therapy. Exception to this criterion; patients with any grade of alopecia are allowed to enter the study.. 5-Patient has received radiotherapy ≤ 4 weeks prior to randomization (≤ 2 weeks for limited field radiation for palliation), and has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia). 6-Patient has a known hypersensitivity to other monoclonal antibodies, platinum-containing compounds, or to any of the excipients of LAG525, spartalizumab, or carboplatin. 7-Patient has symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within the 2 weeks prior to first dose of study treatment. Patients with treated brain metastases should be neurologically stable and witout CNS progression for at least 12 weeks prior to randomization and have discontinued corticosteroid treatment (with the exception of < 10 mg/day of prednisone or equivalent for an indication other than CNS metastases) for at least 4 weeks before first dose of any study treatment.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Other
Trial scope: Specify scope
Efficacy and safety
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
2
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
LAG525
Type of IMP
Immunological
Pharmaceutical class
LAG525 is a high-affinity, ligand-blocking humanized IgG4 antibody (stabilized hinge, S228P) against LAG-3 that blocks the binding of MHC Class II to LAG-3.
Therapeutic indication
Patients with triple negative breast cancer
Therapeutic benefit
'Overall response rate (ORR) per RECIST v1.1 per investigators' assessment up to 8 cycles
Biospecimen retention
Samples with DNA**
Biospecimen description
Central Laboratory Q2 Solutions, The Alba Campus, Rosebank, Livingston, EH54 7EG, United Kingdom Lab Tests to be done: Hematology Hematocrit, Hemoglobin, Platelets, White blood cells, Differential (Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Bands Chemistry Albumin, Alkaline phosphatase, ALT , AST , Gamma-glutamyl-transferase (GGT), Lactate dehydrogenase (LDH), Calcium, Magnesium, Phosphorus, Chloride, Sodium, Potassium, Creatinine, Creatinine clearance, Creatine kinase, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Total Cholesterol, Blood Urea Nitrogen (BUN) or Urea, Uric Acid, Amylase, Lipase, Glucose Coagulation International normalized ratio [INR]), Activated partial thromboplastin time (APTT) Thyroid TSH, Free T3 and Free T4 Hepatitis markers HBV-DNA, HBsAg, HBsAb, HBcAb, HCV RNA-PCR Cytokines IFN-γ, IL-6, IL-1,TNF-α Pregnancy Test serum pregnancy hCG test
Target sample size
6
Actual enrollment target size
3
Date of first enrollment: Type
Actual
Date of first enrollment: Date
31/10/2018
Date of study closure: Type
Actual
Date of study closure: Date
23/07/2020
Recruitment status
Other
Recruitment status: Specify
On Hold
Date of completion
28/06/2019
IPD sharing statement plan
No
IPD sharing statement description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT03499899?term=CLAG525B2101&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinical Trials. gov
NCT03499899
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Joseph
Kattan
Beirut
Lebanon
009613635913
jkattan62@hotmail.com
Hotel Dieu De France
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Dany
Abi Gerges
Bsalim
Lebanon
+9613341960
abgerges@idm.net.lb
Middle East Institute Of Health
Public
Fadi
Farhat
Saida
Lebanon
+9613753155
drfadi.trials@gmail.com
Hammoud Hospital
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu De France
Dr Joseph Kattan
Hematology Oncology
Approved
Middle East Institute of Health
Dr Dany ABi Gerges
Hematology Oncology
Approved
Hammoud Hospital University Medical Center
Dr Fadi Farhat
Hematology Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
03/07/2018
Nancy Alam
nancy.alam@usj.edu.lb
+961 1421000 ext 2335
Middle East Institute of Health
16/08/2018
Ahmad Ibrahim
ahmad_O_Ibrahim@hotmail.com
+961 (0) 3 233 560
Hammoud Hospital University Medical Center
16/07/2018
Ahmad Zaatari
zaatari@hammoudhospital.com
+961 (0) 7 723111 ext 1160
Countries of Recruitment
Name
Australia
Belgium
Canada
France
Germany
Hungary
Italy
Japan
Lebanon
Singapore
Spain
Thailand
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
breast cancer
Breast, unspecified (C50.9)
Tripple negative ABC
Interventions
Intervention
Description
Keyword
Physical examination, height, weight, Hematology, Chemistry, Ferritin, Creatinine, Cleatinine Clearance, Hepatitis, Pregnancy Test, Urine Dipstick, Microscopic Urinalysis, Proteinuria, Urine Pregnancy Test, Liver function test, Ocular exam, audiometry, ECG, Electrocardiogram, PK sampling, vital signs, Growth and development
Physical examination, height, weight, Hematology, Chemistry, Ferritin, Creatinine, Cleatinine Clearance, Hepatitis, Pregnancy Test, Urine Dipstick, Microscopic Urinalysis, Proteinuria, Urine Pregnancy Test, Liver function test, Ocular exam, audiometry, ECG, Electrocardiogram, PK sampling, vital signs, Growth and development
Physical examination, height, weight, Hematology, Chemistry, Ferritin, Creatinine, Cleatinine Clearance, Hepatitis, Pregnancy Test, Urine Dipstick, Microscopic Urinalysis, Proteinuria, Urine Pregnancy Test, Liver function test, Ocular exam, audiometry, ECG, Electrocardiogram, PK sampling, vital signs, Growth and development
Primary Outcomes
Name
Time points
Measure
Overall response rate (ORR) per RECIST v1.1 per investigators' assessment
24 months
24 Months
Key Secondary Outcomes
Name
Time points
Measure
Duration of response (DOR)
3 years
3 years
Overall Survival (OS)
3 years
3 years
Clinical Benefit Rate (CBR)
24 months
24 months
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial