Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).

Part of paid clinical trials in New York, New York.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03742349
Phase
PHASE1
Status
Terminated

Conditions

  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • spartalizumab — BIOLOGICAL
    LIVI (Liquid in vial) Concentrate for Solution for infusion
  • LAG525 — BIOLOGICAL
    LAG525 LIVI (Liquid in vial) Concentrate for Solution for infusion
  • NIR178 — DRUG
    Capsule
  • capmatinib — DRUG
    Tablet
  • MCS110 — BIOLOGICAL
    LIVI (Liquid in vial) Concentrate for Solution for infusion
  • canakinumab — BIOLOGICAL
    LIVI (Liquid in vial) Solution for injection

Study Details

This is a Phase Ib, open label, dose escalation study of spartalizumab + LAG525 in combination with NIR178, capmatinib, MCS110, or canakinumab, followed by a dose expansion in adult patients with advanced or metastatic TNBC. 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.

Key Dates

Start date
Jan 31, 2019
Status verified
May 2025
Primary completion
Feb 6, 2023
Completion
Feb 6, 2023

Study Design

Enrollment
64 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1: spartalizumab + LAG525 + NIR178
    phase Ib (escalation and expansion)
  • Experimental: 2: spartalizumab +LAG525 +capmatinib
    phase Ib (escalation and expansion)
  • Experimental: 3: spartalizumab + LAG525 + MCS110
    phase Ib (escalation and expansion)
  • Experimental: 4: spartalizumab +LAG525 +canakinumab
    phase Ib (escalation and expansion)

Primary Outcome Measure

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of safety [ Time Frame: at month 18 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Columbia University Medical Center- New York Presbyterian ColumbiaNew YorkNew York10032-
Sarah Cannon Research Institute Sarah Cannon ResearchNashvilleTennessee37203-

Find similar trials in New York, NY

By research site
Columbia University Medical Center- New York Presbyterian Columbia· New York, NYSarah Cannon Research Institute Sarah Cannon Research· Nashville, TN

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