^
    almost2years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; This was a sponsor decision and was not a consequence of any safety concern
    Trial termination • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    almost2years
    PLATforM: Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P2, N=196, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    BRAF wild-type • CD8 expression
    |
    Kisqali (ribociclib) • Tabrecta (capmatinib) • spartalizumab (PDR001) • Ilaris (canakinumab) • ieramilimab (LAG525)
    2years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2022 --> Feb 2023 | Trial primary completion date: Oct 2022 --> Feb 2023
    Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    2years
    PLATforM: Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P2, N=196, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: May 2023 --> Jan 2023
    Trial completion date • Metastases
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    BRAF wild-type • CD8 expression
    |
    Kisqali (ribociclib) • Tabrecta (capmatinib) • spartalizumab (PDR001) • Ilaris (canakinumab) • ieramilimab (LAG525)
    over2years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2022 --> Oct 2022 | Trial primary completion date: Jun 2022 --> Oct 2022
    Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    over2years
    Phase I/II study of the LAG-3 inhibitor ieramilimab (LAG525) ± anti-PD-1 spartalizumab (PDR001) in patients with advanced malignancies. (PubMed, J Immunother Cancer)
    Ieramilimab was well tolerated as monotherapy and in combination with spartalizumab. The toxicity profile of ieramilimab in combination with spartalizumab was comparable to that of spartalizumab alone. Modest antitumor activity was seen with combination treatment.
    P1/2 data • Clinical Trial,Phase I • Clinical Trial,Phase II • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    CD8 expression • LAG3 expression
    |
    spartalizumab (PDR001) • ieramilimab (LAG525)
    almost3years
    PLATforM: Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P2, N=196, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | Trial completion date: Jan 2023 --> Jun 2023 | Trial primary completion date: Aug 2022 --> Jan 2023
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    BRAF wild-type • CD8 expression
    |
    Kisqali (ribociclib) • Tabrecta (capmatinib) • spartalizumab (PDR001) • Ilaris (canakinumab) • ieramilimab (LAG525)
    almost3years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=220 --> 64 | Trial completion date: Jan 2022 --> Jun 2022 | Trial primary completion date: Jan 2022 --> Jun 2022
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    3years
    PLATforM: Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P2, N=195, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2022 --> Jan 2023 | Trial primary completion date: Dec 2021 --> Aug 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    BRAF wild-type • CD8 expression
    |
    Kisqali (ribociclib) • Tabrecta (capmatinib) • spartalizumab (PDR001) • Ilaris (canakinumab) • ieramilimab (LAG525)
    3years
    A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab, or With Spartalizumab and Carboplatin, or With Carboplatin, in Patients With Advanced Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=88, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
    Clinical • Trial completion • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative • PGR expression
    |
    carboplatin • spartalizumab (PDR001) • ieramilimab (LAG525)
    almost4years
    A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab, or With Spartalizumab and Carboplatin, or With Carboplatin, in Patients With Advanced Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=88, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jan 2021 --> Aug 2021
    Clinical • Trial completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    carboplatin • spartalizumab (PDR001) • ieramilimab (LAG525)
    almost4years
    Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov)
    P1/2, N=490, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
    Clinical • Trial completion • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • LAG3 (Lymphocyte Activating 3)
    |
    LAG3 expression
    |
    spartalizumab (PDR001) • ieramilimab (LAG525)
    over4years
    Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov)
    Trial completion date: Jul 2020 --> Nov 2020 | Trial primary completion date: Jul 2020 --> Nov 2020
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • LAG3 (Lymphocyte Activating 3)
    |
    LAG3 expression
    |
    spartalizumab (PDR001) • ieramilimab (LAG525)
    over4years
    PLATforM: Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P2, N=195, Recruiting, Novartis Pharmaceuticals | Suspended --> Recruiting | Trial completion date: Aug 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Nov 2021
    Clinical • Enrollment open • Trial completion date • Trial primary completion date • PD(L)-1 Biomarker
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    BRAF mutation • CD8 expression
    |
    Kisqali (ribociclib) • Tabrecta (capmatinib) • spartalizumab (PDR001) • Ilaris (canakinumab) • ieramilimab (LAG525)
    almost5years
    A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab, or With Spartalizumab and Carboplatin, or With Carboplatin, in Patients With Advanced Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=88, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2020 --> Jan 2021
    Clinical • Trial completion date • Combination therapy • PD(L)-1 Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    carboplatin • spartalizumab (PDR001) • ieramilimab (LAG525)
    almost5years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=220, Recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2020 --> Jan 2022 | Trial primary completion date: Oct 2020 --> Jan 2022
    Clinical • Trial completion date • Trial primary completion date • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    almost5years
    A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab, or With Spartalizumab and Carboplatin, or With Carboplatin, in Patients With Advanced Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=88, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy • PD(L)-1 Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    carboplatin • spartalizumab (PDR001) • ieramilimab (LAG525)