^
    4d
    A novel anti-LAG-3/TIGIT bispecific antibody exhibits potent anti-tumor efficacy in mouse models as monotherapy or in combination with PD-1 antibody. (PubMed, Sci Rep)
    The tumor volume inhibition rate for ZGGS15 at 2 mg/kg was 69.70%, and for ZGGS15 at 5 mg/kg plus nivolumab at 1 mg/kg, it was 94.03% (p < 0.001). Our data reveal that ZGGS15 exhibits potent anti-tumor efficacy without eliciting ADCC or CDC or causing cytokine production, therefore having a safe profile.
    Preclinical • Journal • Combination therapy
    |
    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule)
    |
    Opdivo (nivolumab) • ZGGS15
    8d
    Testing Nivolumab and BMS-986016 (Relatlimab) as Potentially Targeting Treatment in Cancers That Are LAG-3+ and Have Mismatch Repair Deficiency (MATCH - Subprotocol Z1M) (clinicaltrials.gov)
    P2, N=0, Withdrawn, National Cancer Institute (NCI)
    New P2 trial • Mismatch repair
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016) • ABP 206 (nivolumab biosimilar)
    11d
    Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=59, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: May 2024 --> Feb 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    11d
    A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=180, Recruiting, Hoffmann-La Roche | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • tobemstomig (RG6139)
    13d
    R3767-ONC-1613: Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers (clinicaltrials.gov)
    P1, N=333, Completed, Regeneron Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Apr 2024 | Trial primary completion date: Dec 2024 --> Apr 2024
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    13d
    A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma) (clinicaltrials.gov)
    P1/2, N=110, Completed, Hoffmann-La Roche | Recruiting --> Completed | N=336 --> 110 | Trial completion date: Jul 2025 --> Mar 2024 | Trial primary completion date: Jan 2025 --> Sep 2023
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • tiragolumab (RG6058) • tobemstomig (RG6139)
    13d
    A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01) (clinicaltrials.gov)
    P1/2, N=80, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial • Combination therapy • Tumor mutational burden
    |
    favezelimab/pembrolizumab (MK-4280A) • vibostolimab/pembrolizumab (MK-7684A)
    19d
    Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC) (clinicaltrials.gov)
    P2, N=140, Not yet recruiting, Regeneron Pharmaceuticals
    New P2 trial • Combination therapy
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    19d
    Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003) (clinicaltrials.gov)
    P1/2, N=174, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Oct 2027 --> Apr 2028 | Trial primary completion date: Oct 2027 --> Apr 2028
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • favezelimab (MK-4280)
    20d
    Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov)
    P1, N=78, Active, not recruiting, Symphogen A/S | N=148 --> 78 | Trial completion date: Jan 2025 --> Jun 2024
    Enrollment change • Trial completion date • Combination therapy • Metastases
    |
    FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation • FGFR2 mutation • FGFR2 fusion
    |
    irinotecan • S95018 • Sym021 • Sym022
    22d
    Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors (clinicaltrials.gov)
    P1, N=33, Not yet recruiting, Washington University School of Medicine | Trial completion date: Mar 2030 --> Jun 2030 | Trial primary completion date: Jun 2028 --> Sep 2028
    Trial completion date • Trial primary completion date • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    25d
    Pseudoprogression in a patient with metastatic melanoma treated with PD-1 and LAG-3 inhibition. (PubMed, Melanoma Res)
    Here, we report a case of an 89-year-old patient with metastatic melanoma to the liver, lung and lymph nodes, who underwent treatment with Opdualag (combining anti-PD-1 nivolumab and anti-lymphocyte-activation gene 3 relatlimab ICBs), and developed pseudoprogression after two cycles of therapy. The patient experienced a radiographic increase in liver metastatic lesion size, but was found to have a subsequent reduction in these lesions. The patient has been on therapy for 18 months without evidence of disease progression and continues to be clinically well-appearing.
    Journal • Metastases
    |
    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Opdualag (nivolumab/relatlimab) • relatlimab (BMS-986016)
    28d
    NCI-2018-01517: Nivolumab and Relatlimab in Treating Participants With Advanced Chordoma (clinicaltrials.gov)
    P2, N=10, Completed, Jonsson Comprehensive Cancer Center | Active, not recruiting --> Completed | Trial completion date: Apr 2025 --> Sep 2023 | Trial primary completion date: Apr 2024 --> Sep 2023
    Trial completion • Trial completion date • Trial primary completion date • Tumor mutational burden • Metastases
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    1m
    A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=180, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • tobemstomig (RG6139)
    1m
    Natera and Alliance for Clinical Trials in Oncology Announce Activation of Alliance A032103 (MODERN): A Randomized, Phase II/III Adjuvant Trial in Urothelial Cancer (Businesswire)
    "Natera, Inc...today announced the launch of Alliance A032103 (MODERN), a randomized, phase II/III, biomarker-integrated trial. Alliance A032103 (MODERN) will utilize Signatera, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, to help guide personalized treatment based on molecular status in patients diagnosed with muscle-invasive urothelial cancer (MIUC) after radical cystectomy....In the Alliance A032103 (MODERN) trial, approximately 1,000 patients will be enrolled at more than 300 sites in North America. Patients will be divided into two cohorts based on an initial assessment of MRD status. Patients who are Signatera MRD-positive will have treatment randomized to either nivolumab, a PD-1 antibody, or escalation with nivolumab, a PD-1 antibody plus relatlimab, a LAG-3 antibody; LAG-3 and PD-1 are distinct inhibitory immune checkpoints."
    Trial status
    |
    Signatera™
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    1m
    Complete Remission of Metastatic Melanoma of the Scalp Following Treatment With Nivolumab Plus Relatlimab. (PubMed, Am Surg)
    He continued to show no evidence of disease at recent follow-up. Treatment of metastatic melanoma of the skin with nivolumab and relatlimab is an effective approach showing greater benefit to patients than nivolumab alone.
    Journal • Metastases
    |
    LAG3 (Lymphocyte Activating 3)
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    2ms
    XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, University of California, San Francisco | Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P1 | N=46 --> 6
    Enrollment closed • Phase classification • Enrollment change • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • LAG3 (Lymphocyte Activating 3)
    |
    bavunalimab (XmAb22841) • izuralimab (XmAb23104)
    2ms
    Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma (clinicaltrials.gov)
    P2, N=57, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Nov 2027 --> Mar 2027 | Trial primary completion date: Nov 2024 --> Mar 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
    2ms
    Pilot Study of Nivolumab w/Ipilimumab or Relatlimab in Surgically Resectable Melanoma Brain Metastases (clinicaltrials.gov)
    P1, N=1, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | N=24 --> 1
    Enrollment closed • Enrollment change
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
    |
    PD-1 expression
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab) • relatlimab (BMS-986016)
    2ms
    Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma. (clinicaltrials.gov)
    P1, N=34, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1 trial • Metastases
    |
    Anniko (penpulimab) • TQB2223
    2ms
    Neoadjuvant nivolumab or nivolumab plus LAG-3 inhibitor relatlimab in resectable esophageal/gastroesophageal junction cancer: a phase Ib trial and ctDNA analyses. (PubMed, Nat Med)
    Our findings provide insights into the safety profile of combined PD-1 and LAG-3 blockade in gastroesophageal cancer and highlight the potential of ctDNA analysis to dynamically assess systemic tumor burden during neoadjuvant ICI that may open a therapeutic window for future intervention. ClinicalTrials.gov registration: NCT03044613 .
    P1 data • Journal • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA
    |
    PD-L1 (Programmed death ligand 1) • LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression • LAG3 expression
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    2ms
    ClearMe: Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma (clinicaltrials.gov)
    P2, N=54, Recruiting, University Health Network, Toronto
    New P2 trial
    |
    Opdualag (nivolumab/relatlimab)
    2ms
    Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=59, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting | N=96 --> 59 | Trial primary completion date: Feb 2025 --> May 2024
    Enrollment closed • Enrollment change • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    2ms
    RELATIVITY-073: A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors (clinicaltrials.gov)
    P2, N=266, Active, not recruiting, Bristol-Myers Squibb | Trial completion date: Jan 2025 --> Sep 2024
    Trial completion date • Combination therapy • Metastases • Immuno-oncology
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    2ms
    Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting
    Enrollment open
    |
    TMB (Tumor Mutational Burden)
    |
    PD-L1 expression
    |
    PD-L1 IHC 28-8 pharmDx
    |
    Opdualag (nivolumab/relatlimab) • relatlimab (BMS-986016)
    2ms
    A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov)
    P1, N=140, Recruiting, Boehringer Ingelheim | Phase classification: P1a/1b --> P1
    Phase classification • Combination therapy • Metastases
    |
    TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 mutation • TP53 wild-type • TP53 amplification
    |
    brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    2ms
    Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (clinicaltrials.gov)
    P1, N=30, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab) • relatlimab (BMS-986016)
    2ms
    Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, H. Lee Moffitt Cancer Center and Research Institute
    New P1 trial • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab) • relatlimab (BMS-986016)
    2ms
    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)
    2ms
    CA224-1065: Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Melanoma Institute Australia
    New P2 trial
    |
    Opdualag (nivolumab/relatlimab) • relatlimab (BMS-986016)
    2ms
    RELATIVITY-123: A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer (clinicaltrials.gov)
    P3, N=700, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • RAS wild-type
    |
    Opdivo (nivolumab) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil) • Opdualag (nivolumab/relatlimab)
    3ms
    TURANDORELA: Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab (clinicaltrials.gov)
    P2, N=90, Recruiting, The Netherlands Cancer Institute | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    3ms
    Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov)
    P1, N=148, Active, not recruiting, Symphogen A/S | Phase classification: P1b --> P1
    Phase classification
    |
    FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation • FGFR2 mutation • FGFR2 fusion
    |
    irinotecan • S95018 • Sym021 • Sym022
    3ms
    A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection in Patients With Solid Tumor or Lymphoma (clinicaltrials.gov)
    P1, N=18, Completed, Shanghai Henlius Biotech | Active, not recruiting --> Completed | N=11 --> 18
    Trial completion • Enrollment change • Metastases
    |
    HLX26
    3ms
    A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery (clinicaltrials.gov)
    P3, N=1530, Recruiting, Regeneron Pharmaceuticals | Trial primary completion date: Feb 2030 --> May 2028
    Trial primary completion date • Surgery
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    3ms
    A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients (clinicaltrials.gov)
    P2, N=132, Recruiting, Shanghai Henlius Biotech | N=60 --> 132
    Enrollment change
    |
    PD-L1 (Programmed death ligand 1) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression • ROS1 rearrangement • LAG3 expression
    |
    carboplatin • albumin-bound paclitaxel • Hansizhuang (serplulimab) • HLX26
    3ms
    RELATIVITY-111: Study of Relatlimab in Combination With Nivolumab in Chinese Participants (clinicaltrials.gov)
    P1, N=6, Completed, Bristol-Myers Squibb | Recruiting --> Completed | N=12 --> 6 | Trial completion date: Nov 2025 --> Jan 2024 | Trial primary completion date: Nov 2025 --> Jan 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    3ms
    KEYMAKER-U04 Substudy: A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04) (clinicaltrials.gov)
    P1/2, N=390, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Padcev (enfortumab vedotin-ejfv) • favezelimab/pembrolizumab (MK-4280A) • vibostolimab/pembrolizumab (MK-7684A)
    3ms
    Study to Evaluate the Safety and Tolerability of ABL501, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL501 in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=36, Recruiting, ABL Bio, Inc. | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    ABL501
    3ms
    KEYFORM-007: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007) (clinicaltrials.gov)
    P3, N=432, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Nov 2024 --> Nov 2025
    Trial completion date • Metastases
    |
    Keytruda (pembrolizumab) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil) • favezelimab/pembrolizumab (MK-4280A)
    3ms
    Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=96, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    3ms
    Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=35, Active, not recruiting, Bristol-Myers Squibb | Trial completion date: Sep 2023 --> Jul 2025 | Trial primary completion date: Sep 2023 --> Jul 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)