Table 2.
Current ongoing clinical trials for LAG-3-specific monoclonal antibodies or antagonist agents.
| Name of the compound | Mechanism of action | Study phase | Trial ID | Targeted population | Status |
|---|---|---|---|---|---|
| INCMGA00012 + INCAGN02385 + INCAGN02390 | Anti-PD-1 + anti-LAG-3 + anti-TIM-3 | Phase I/II | ClinicalTrials.gov NCT04370704 |
The study will determine recommended phase II dose (RP2D) for all study drugs, based on the safety and tolerability of the following combinations: INCAGN02385 + INCAGN02390 and INCAGN02385 + INCAGN02390 + INCMGA00012 | Recruiting |
| REGN3767 | Anti-LAG-3 | Phase I | ClinicalTrials.gov NCT03005782 |
The primary objectives in the dose-escalation phase are to evaluate the safety and PK to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma | Active, not recruiting |
| REGN3767 + REGN2810 | Anti-LAG-3 + anti-PD-1 | ||||
| Eftilagimod alpha (IMP321) + pembrolizumab | Soluble LAG-3 fusion protein | Phase II | ClinicalTrials.gov NCT03625323 |
Metastatic NSCLC, recurrent PD-X refractory NSCLC, recurrent, or metastatic HNSCC (TACTI-002) | Active, not recruiting |
| Anti PD-1 mAb | |||||
| RO7247669 | Anti-PD-1/anti-LAG-3 bispecific antibody | Phase I | ClinicalTrials.gov NCT04140500 |
Participants with solid tumors, metastatic melanoma, NSCLC, esophageal squamous cell carcinoma | Recruiting |
| EMB-02 | Anti-PD-1/LAG-3 bispecific antibody | Phase I/II | ClinicalTrials.gov NCT04618393 |
The primary purpose of this study is to identify the RP2Ds and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds | Recruiting |
| FS118 | Anti-PD-L1/anti-LAG-3 bispecific antibody | Phase I/II | ClinicalTrials.gov NCT03440437 |
This is a phase I/II, multicenter, open-label, multiple-dose, first-in-human study, designed to systematically assess safety and tolerability, to identify the maximum tolerated dose and/or RP2D for FS118 in participants with advanced tumors and to determine the efficacy of FS118 in participants with SCCHN | Recruiting |
| Nivolumab + relatlimab | Anti-PD-1 + anti-LAG-3 | Phase II | ClinicalTrials.gov NCT03623854 |
This phase II trial studies how well nivolumab and relatlimab work in treating participants with chordoma that has spread to other places in the body | Recruiting |
| MGD013 | Anti-PD-1, anti-LAG-3 bispecific DART protein | Phase I | ClinicalTrials.gov NCT03219268 |
In patients with advanced solid tumors, hematologic neoplasms, GC, ovarian cancer, gastroesophageal cancer, HER2-positive breast cancer, HER2-positive GC, diffuse large B cell lymphoma (DLBCL) | Active, not recruiting |
| MGD013 + margetuximab | Anti-PD-1, anti-LAG-3 bispecific DART protein + anti-HER2 (human epidermal growth factor receptor 2) mAb | ||||
| BMS-986016 | Anti-LAG-3 monoclonal antibody | Phase I | ClinicalTrials.gov NCT02966548 |
This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with nivolumab in subjects with advanced solid tumors | Active, not recruiting |
| BMS-986016 + nivolumab | Anti-LAG-3 monoclonal antibody + anti-PD-1 mAb | ||||
| Relatlimab + nivolumab + BMS-986205 | Anti-LAG-3 + anti-PD-1 + reduce kynurenine production | Phase I/II | ClinicalTrials.gov NCT03459222 |
The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naïve and pretreated populations across select advanced tumor types | Recruiting |
| Relatlimab + nivolumab + ipilimumab | Anti-LAG-3 + anti-PD-1 + anti-CTLA-4 | ||||
| Nivolumab | Anti-PD-1 | Phase II | ClinicalTrials.gov NCT04080804 |
The aim of this study is to potentiate adaptive immunity to enhance the antitumor activity of anti-PD-1 antibody by the addition of anti-CTLA-4 antibody or anti-LAG-3 antibody (relatlimab) given in subjects with resectable locally advanced HNSCC prior to surgical resection | Recruiting |
| Nivolumab + relatlimab | Anti-PD-1 + anti-LAG-3 | ||||
| Nivolumab + ipilimumab | Anti-PD-1 + anti-CTLA-4 | ||||
| Relatlimab | Anti-LAG-3 | Phase II | ClinicalTrials.gov NCT03743766 |
The main goal of this study is to evaluate the antitumor activity of relatlimab and nivolumab in combination in subjects with unresectable or metastatic melanoma who have not received prior treatment with immunotherapy | Recruiting |
| Nivolumab | Anti-PD-1 | ||||
| Relatlimab + nivolumab | Anti-LAG-3 + anti-PD-1 | ||||
| Enoblituzumab + retifanlimab | Anti-B7-H3 antibody + anti-PD-1 antibody | Phase II | ClinicalTrials.gov NCT04634825 |
This is a phase II study of enoblituzumab combined with either retifanlimab or tebotelimab administered as first-line treatment to patients with recurrent or metastatic SCCHN | Terminated |
| Enoblituzumab + tebotelimab | Anti-B7-H3 antibody + PD-1 and LAG-3 bispecific DART molecule | ||||
| Nivolumab + relatlimab | Anti-PD-1 + anti-LAG-3 | Phase II | ClinicalTrials.gov NCT04326257 |
In patients with recurrent and/or metastatic HNSCC (R/M HNSCC) who have failed prior immunotherapy with anti-PD-1 or PD-L1 mAb therapy | Recruiting |
| Nivolumab + ipilimumab | Anti-PD-1 + anti-CTLA-4 | ||||
| Margetuximab + INCMGA00012 | Fc-modified anti-HER2 monoclonal antibody + chemo | Phase II/III | ClinicalTrials.gov NCT04082364 |
In patients with HER2-positive GC or gastroesophageal junction cancer | Active, not recruiting |
| Margetuximab + INCMGA00012 + chemo | Fc-modified anti-HER2 monoclonal antibody + anti-PD-1 + chemo | ||||
| Margetuximab + MGD013 + chemo | Fc-modified anti-HER2 monoclonal antibody + anti-PD-1, anti-LAG-3 dual checkpoint inhibitor DART molecule + chemo | ||||
| Margetuximab + chemo (XELOX or mFOLFOX-6) | Fc-modified anti-HER2 monoclonal antibody + chemo | ||||
| Trastuzumab + chemo (XELOX or mFOLFOX-6) | Anti-HER2 monoclonal antibody + chemo | ||||
| LAG525 + spartalizumab (in unselected patients) | Anti-LAG-3 + anti-PD-1 | Phase II | ClinicalTrials.gov NCT03484923 |
To evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma | Active, not recruiting |
| Capmatinib + spartalizumab | c-Met tyrosine kinase(c-Met) inhibitor + anti-PD-1 | ||||
| Canakinumab + spartalizumab | Anti-interleukin-1 beta + anti-PD-1 | ||||
| Ribociclib + spartalizumab | Cyclin-dependent kinase inhibitor + anti-PD-1 | ||||
| LAG525 + spartalizumab (in LAG-3 positive patients) | Anti-LAG-3 + anti-PD-1 | ||||
| Nivolumab + relatlimab | Anti-PD-1 + anti-LAG-3 | Phase II | ClinicalTrials.gov NCT03642067 |
To evaluate the safety and clinical activity of nivolumab and relatlimab in patients with metastatic or locally advanced microsatellite stable colorectal cancer | Recruiting |
| Nivolumab | Anti-PD-1 | Phase I | ClinicalTrials.gov NCT04658147 |
To determine the safety and tolerability of neoadjuvant/adjuvant nivolumab or nivolumab plus relatlimab in patients with hepatocellular carcinoma | Recruiting |
| Nivolumab + relatlimab | Anti-PD-1 + anti-LAG-3 | ||||
| Nivolumab + relatlimab 480 mg/160 mg (co-administered) or 480 mg/960 mg (sequential administration) | Anti-PD-1 + anti-LAG-3 | Phase II | ClinicalTrials.gov NCT03607890 |
In patients with microsatellite instability high solid tumors refractory to prior PD-(L)1 therapy | Recruiting |
| XmAb®22841 | Anti CTLA-4/LAG-3 bispecific antibody | Phase I | ClinicalTrials.gov NCT03849469 |
In subjects with select advanced solid tumors | Active, not recruiting |
| XmAb®22841 + pembrolizumab | Anti-CTLA-4/LAG-3 bispecific antibody + anti-PD-1 |
CTLA-4, cytotoxic tumor lymphocyte antigen 4; Fc, fragment crystallizable; GC, gastric cancer; HNSCC, squamous cell carcinoma of the head and neck; LAG-3, lymphocyte activation gene-3; mAb, monoclonal antibody; NSCLC, non-small cell lung cancer; PD-1, programmed cell death-1; PD-L1, programmed cell death-ligand 1; PK, pharmacokinetics; SCCHN, squamous cell carcinoma of the head and neck.