^
    2d
    Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation) (clinicaltrials.gov)
    P2, N=494, Not yet recruiting, Melanoma Institute Australia | Trial completion date: Sep 2037 --> Jan 2038 | Trial primary completion date: Dec 2027 --> Mar 2028
    Trial completion date • Trial primary completion date • IO biomarker
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    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
    2d
    A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Regeneron Pharmaceuticals | Trial completion date: Nov 2029 --> Dec 2030 | Initiation date: Mar 2025 --> Mar 2026 | Trial primary completion date: Apr 2027 --> Jun 2028
    Trial completion date • Trial initiation date • Trial primary completion date • IO biomarker
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    PD-L1 (Programmed death ligand 1)
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    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    3d
    Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis (clinicaltrials.gov)
    P1/2, N=15, Not yet recruiting, University of Wisconsin, Madison
    New P1/2 trial
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    melphalan • Opdualag (nivolumab/relatlimab-rmbw) • Melblez Kit (melphalan hepatic delivery system) • relatlimab (BMS-986016)
    3d
    Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P2, N=66, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New P2 trial
    |
    capecitabine • oxaliplatin • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    5d
    Long-term outcomes of preoperative nivolumab with or without relatlimab in patients with resectable non-small-cell lung cancer (NEOpredict-Lung). (PubMed, Eur J Cancer)
    Short course preoperative nivolumab with or without relatlimab showed encouraging efficacy and survival outcomes, which compare favorably with chemo-immunotherapy-based perioperative treatment regimens.
    Journal
    |
    LAG3 (Lymphocyte Activating 3)
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    14d
    A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors (clinicaltrials.gov)
    P1, N=15, Recruiting, Shenyang Sunshine Pharmaceutical Co., LTD. | N=10 --> 15
    Enrollment change
    15d
    RELATIVITY 059: A Study to Assess Relatlimab and Nivolumab Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=24, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed
    Trial completion
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
    20d
    LBL-007-CN-004: A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors (clinicaltrials.gov)
    P1/2, N=490, Recruiting, Nanjing Leads Biolabs Co.,Ltd | Trial completion date: Dec 2025 --> Jul 2026 | Trial primary completion date: Oct 2025 --> May 2026
    Trial completion date • Trial primary completion date
    |
    cisplatin • gemcitabine • docetaxel • Tevimbra (tislelizumab-jsgr) • alcestobart (LBL-007)
    20d
    International real-world study of combination immunotherapy sequences in metastatic melanoma. (PubMed, J Immunother Cancer)
    Our findings indicate that rela/nivo may remain active following anti-PD-1 or ipi/nivo therapy. Additionally, our results suggest that sequencing ipi/nivo before rela/nivo may yield better outcomes than starting with rela/nivo. Patients who respond to the first combination regimen appear to derive greater benefit from the second. Further efforts are needed to optimize sequencing strategies in advanced melanoma, and future studies should consider the impact of prior treatment outcomes.
    Retrospective data • Journal • Real-world evidence
    |
    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
    24d
    Lead-in therapy targeting PD1 and/or LAG3 imposes distinct immune phenotypes in first-line treatment of metastatic melanoma. (PubMed, medRxiv)
    The analyses of component agents afforded by this novel lead-in trial has identified differential clinical and immunological modulation of anti-PD1 and anti-LAG3 in comparison to the combination therapy. Lead-in monotherapy with nivolumab or relatlimab reduces efficacy to the comboMPRbx serves as an early surrogate marker of response and long-term PFS Relatlimab lead-in led to CD8 + T cell:Treg clustering in the TME and poor PFS Combo therapy non-responders had decreased CD14 + CD16 - HLA-DR low CD33 dim monocytes.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • CD33 (CD33 Molecule) • CD14 (CD14 Molecule) • FOXP3 (Forkhead Box P3)
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    27d
    TQB2223-AK105-Ib-01: Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma. (clinicaltrials.gov)
    P1, N=22, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=34 --> 22 | Recruiting --> Terminated | Trial primary completion date: Feb 2025 --> Nov 2025; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
    Enrollment change • Trial termination • Trial primary completion date
    |
    Anniko (penpulimab) • Sym022
    29d
    Neo ReNi II: A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II Cutaneous Melanoma (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, Melanoma Institute Australia | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • NRAS mutation • NRAS wild-type
    |
    Opdualag (nivolumab/relatlimab-rmbw)