Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Spartalizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

LIVI (Liquid in vial) Concentrate for Solution for infusion

spartalizumab

LAG525 LIVI (Liquid in vial) Concentrate for Solution for infusion

LAG525

NIR178

capmatinib

MCS110

LIVI (Liquid in vial) Solution for injection

canakinumab

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.

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

A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Immunotherapy Combinations in Adult Patients With Triple-negative Breast Cancer

Novartis Pharmaceuticals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).	NCT03742349	Triple Negative...	spartalizumab LAG525 NIR178 capmatinib MCS110 canakinumab	18 Years -	Novartis
Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).	NCT03742349	Triple Negative...	spartalizumab LAG525 NIR178 capmatinib MCS110 canakinumab	18 Years -	Novartis

Spots Global Cancer Trial Database for phase ib, tnbc, advanced, metastatic, immunotherapy, pdr001,