^
    2ms
    Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=61, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    4ms
    Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov)
    P2, N=176, Active, not recruiting, Incyte Biosciences International Sàrl | Trial completion date: Jun 2025 --> Jul 2026
    Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    5ms
    First-in-human phase I open-label study of the LAG-3 antagonist antibody INCAGN02385 in patients with select advanced or metastatic solid tumors. (PubMed, Oncologist)
    INCAGN02385 exhibited linear PK and preliminary evidence of disease control in this heavily pretreated population, consistent with other LAG-3-targeting monotherapies. A 350-mg Q2W dose was selected for phase II studies that will focus on combinations of INCAGN02385 with other ICIs.
    P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD4 (CD4 Molecule)
    |
    tuparstobart (INCAGN2385)
    6ms
    POD1UM-204: Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. (clinicaltrials.gov)
    P2, N=206, Active, not recruiting, Incyte Corporation | Trial primary completion date: Apr 2025 --> Apr 2026
    Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon)
    |
    PD-L1 expression • MSI-H/dMMR • FGFR mutation
    |
    Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    10ms
    TRICK-MCC: Triple Immune Checkpoint Inhibition for Advanced or Metastatic PD-(L)1 Refractory Merkel Cell Carcinoma (clinicaltrials.gov)
    P2, N=12, Active, not recruiting, University of Washington | N=20 --> 12 | Trial completion date: Dec 2029 --> Apr 2027 | Trial primary completion date: Dec 2029 --> Jan 2027 | Recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    1year
    POD1UM-204: Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. (clinicaltrials.gov)
    P2, N=206, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=300 --> 206
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon)
    |
    PD-L1 expression • MSI-H/dMMR • FGFR mutation • FGFR1 mutation
    |
    Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    over1year
    PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL (clinicaltrials.gov)
    P1, N=0, Withdrawn, University of Alabama at Birmingham | N=18 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • CAR T-Cell Therapy • Checkpoint inhibition • Checkpoint block
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    over1year
    Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov)
    P2, N=176, Active, not recruiting, Incyte Biosciences International Sàrl | Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: May 2024 --> Feb 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    almost2years
    PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, University of Alabama at Birmingham
    New P1 trial • CAR T-Cell Therapy • Checkpoint inhibition • Checkpoint block
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    almost2years
    Optimus: An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=30, Terminated, Incyte Corporation | Trial completion date: Jun 2024 --> Jan 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Jan 2024; Business Decision. No safety concerns contributed to this decision.
    Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    2years
    Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=61, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=146 --> 61
    Enrollment closed • Enrollment change
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    2years
    Optimus: An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=45 --> 30
    Enrollment closed • Enrollment change • Combination therapy
    |
    Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)