Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).
NCT ID: NCT03742349
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
64 participants
INTERVENTIONAL
2019-01-31
2023-02-06
Brief Summary
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During the dose-escalation part of each treatment arm, patients will be treated with fixed doses of spartalizumab + LAG525 in combination with partner investigational drugs to be escalated until the MTD is reached or a lower RDE is established: NIR178, capmatinib, MCS110, or canakinumab. It is anticipated that other partner study drugs may be added in the future by protocol amendment.
After the determination of the MTD/RDE for a particular treatment arm, dose expansion may begin in that arm in order to further assess safety, tolerability, PK/PD, and anti-tumor activity of each combination at the MTD/RDE. Dose expansion arms may initiate only after consideration by the Investigators and Novartis of all available toxicity information, the assessment of risk to future patients from the BLRM, and the available PK, preliminary efficacy, and PD information. There is no requirement for dose-escalation treatment arms reaching an MTD/RDE to proceed to dose expansion.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1: spartalizumab + LAG525 + NIR178
phase Ib (escalation and expansion)
spartalizumab
LIVI (Liquid in vial) Concentrate for Solution for infusion
LAG525
LAG525 LIVI (Liquid in vial) Concentrate for Solution for infusion
NIR178
Capsule
2: spartalizumab +LAG525 +capmatinib
phase Ib (escalation and expansion)
spartalizumab
LIVI (Liquid in vial) Concentrate for Solution for infusion
LAG525
LAG525 LIVI (Liquid in vial) Concentrate for Solution for infusion
capmatinib
Tablet
3: spartalizumab + LAG525 + MCS110
phase Ib (escalation and expansion)
spartalizumab
LIVI (Liquid in vial) Concentrate for Solution for infusion
LAG525
LAG525 LIVI (Liquid in vial) Concentrate for Solution for infusion
MCS110
LIVI (Liquid in vial) Concentrate for Solution for infusion
4: spartalizumab +LAG525 +canakinumab
phase Ib (escalation and expansion)
spartalizumab
LIVI (Liquid in vial) Concentrate for Solution for infusion
LAG525
LAG525 LIVI (Liquid in vial) Concentrate for Solution for infusion
canakinumab
LIVI (Liquid in vial) Solution for injection
Interventions
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spartalizumab
LIVI (Liquid in vial) Concentrate for Solution for infusion
LAG525
LAG525 LIVI (Liquid in vial) Concentrate for Solution for infusion
NIR178
Capsule
capmatinib
Tablet
MCS110
LIVI (Liquid in vial) Concentrate for Solution for infusion
canakinumab
LIVI (Liquid in vial) Solution for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients should have received standard chemotherapy for advanced or metastatic disease but should not have received more than 2 prior lines of chemotherapy. Neoadjuvant or adjuvant chemotherapy will count as one prior line.
* Patients must have received prior systemic treatment that included taxane-based chemotherapy for neoadjuvant or metastatic disease.
* Patients must have a site of disease amenable to core needle biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at screening, and during therapy on the study. Exceptions may be considered after documented discussion with Novartis. Patients with available archival tumor tissue obtained ≤6 months prior to study treatment initiation do not need to undergo a new tumor biopsy at screening, if the patient has not received any anti-cancer therapy since the biopsy was taken, and if adequate tissue is available.
Exclusion Criteria
* Presence of 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 2 weeks prior to initiating study treatment.
* History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients.
* Impaired cardiac function or clinically significant cardiac disease.
* HIV infection.
* Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, including those with inactive disease for patients receiving either capmatinib, MCS110 or canakinumab.
* Active, known or suspected autoimmune disease.
* History of or current interstitial lung disease or pneumonitis grade ≥ 2.
* Subjects with tuberculosis (TB), for patients receiving either MCS110 or canakinumab.
Other eligibility criteria apply.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Columbia University Medical Center- New York Presbyterian Columbia
New York, New York, United States
Sarah Cannon Research Institute Sarah Cannon Research
Nashville, Tennessee, United States
Novartis Investigative Site
Westmead, New South Wales, Australia
Novartis Investigative Site
Shatin, New Territories, Hong Kong, Hong Kong
Novartis Investigative Site
Tel Aviv, , Israel
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Countries
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Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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2018-002244-82
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CADPT01A12101C
Identifier Type: -
Identifier Source: org_study_id
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