Relatlimab Clinical Trials

What Is Relatlimab?

Relatlimab is a medication currently under investigation in clinical trials for various cancers. It is a human IgG4 LAG-3 blocking antibody. This means that relatlimab works by targeting and blocking the LAG-3 (Lymphocyte-Activation Gene 3) protein, which is found on certain immune cells. By blocking LAG-3, relatlimab aims to enhance the activity of the immune system against cancer cells. It is often studied in combination with other immunotherapies, such as nivolumab, which is a PD-1 blocking antibody, to further boost the body's anti-tumor response.

Clinical trials for relatlimab began in 2013, with the latest trial starting in 2026. A total of 90 clinical trials have involved relatlimab, enrolling 25,158 participants. While many trials are ongoing, 23 have been completed. The primary focus of these studies is on various forms of melanoma, but relatlimab is also being explored for other advanced cancers.

Uses and Conditions Under Study

Relatlimab is being studied for its potential to treat several types of cancer, primarily focusing on melanoma. Melanoma is a serious form of skin cancer that can spread to other parts of the body. Relatlimab, often in combination with other immunotherapies, aims to stimulate the immune system to fight these cancer cells. Various forms of melanoma, including metastatic, advanced, cutaneous, and unresectable types, are being investigated in a combined total of 34 trials.

Beyond melanoma, relatlimab is also under investigation for a broader range of advanced cancers and solid tumors. These studies seek to understand if the immune-boosting effects of relatlimab can be beneficial across different cancer types. Broader categories like advanced cancer and advanced solid tumors are being explored in 11 trials.

Additionally, relatlimab is being evaluated for specific internal cancers. This includes Gastric Cancer, which affects the stomach, and Non-small Cell Lung Cancer, a common type of lung cancer. Each of these conditions is being studied in 3 trials, contributing to the understanding of relatlimab's potential in diverse oncological settings.

Major sponsors of these trials include Bristol-Myers Squibb, which is leading 30 trials, along with academic institutions like the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and M.D. Anderson Cancer Center.

Dosing

Relatlimab is primarily studied as an injectable medication, often administered in combination with other immunotherapies like nivolumab. It has been investigated in both intravenous (IV) and subcutaneous (SC) fixed-dose combination (FDC) formulations. Specific dosage forms studied include the Nivolumab + Relatlimab Fixed-Dose Combination (FDC) for both IV and SC administration, as well as single agent vials.

Various strengths of relatlimab have been explored in clinical trials. One common fixed-dose combination involves nivolumab 480 mg and relatlimab 160 mg, administered on Day 1 of each 28-day cycle for up to 2 years. Other studied combinations include nivolumab plus relatlimab at 360 mg/360 mg, and combinations with relatlimab at 80 mg or 240 mg with nivolumab. In some neoadjuvant settings, relatlimab has been given for 2 doses on days 1 and 22.

The dosing regimens are tailored to the specific cancer type and the combination therapy being used. For instance, in one trial (NCT05546221), relatlimab is part of a combination with sarilumab, ipilimumab, and nivolumab for patients with advanced solid tumors. Another trial (NCT04724934) evaluates relatlimab with nivolumab as first-line treatment for melanoma.

Side Effects

In a study (NCT02750514) of patients with advanced non-small cell lung cancer, the combination of Relatlimab with nivolumab was compared to nivolumab alone for overall safety. All patients (100.0%) receiving the combination of Relatlimab and nivolumab experienced adverse events (AEs), which was similar to the 100.0% of patients receiving nivolumab alone. Serious adverse events (SAEs) occurred in 61.1% of patients on the combination therapy, compared to 57.1% on nivolumab alone. However, fewer patients on the combination therapy (5.6%) discontinued treatment due to AEs, compared to 14.3% of patients on nivolumab alone. Deaths occurred in 66.7% of patients on the combination, versus 57.1% on nivolumab monotherapy.

Specific laboratory abnormalities were also observed in studies involving Relatlimab in combination with nivolumab. In the non-small cell lung cancer study (NCT02750514), 0 to 1 participant experienced hepatic (liver) test abnormalities with

Currently Recruiting Trials

Relatlimab is being investigated in numerous clinical trials to explore its potential in treating various cancers, often in combination with other immunotherapies. These studies aim to improve outcomes for patients with advanced or metastatic disease by targeting specific pathways that help the immune system fight cancer.

• A Phase 1/2 study, NCT07281924, sponsored by the University of Wisconsin, Madison, is evaluating the safety and effectiveness of combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) for patients with metastatic melanoma and liver metastases. This trial is seeking to enroll 15 participants.
• NYU Langone Health is sponsoring a Phase 4 study, NCT07504796, which investigates using circulating tumor DNA (ctDNA) to guide first-line therapy for advanced or metastatic melanoma. This study aims to enroll 90 participants.
• The Melanoma Institute Australia is conducting a Phase 2 trial, NCT06999980, called Neo IRENIE, for patients with stage 3 cutaneous melanoma and mucosal melanoma who are candidates for surgery. This study is exploring new immunotherapy combinations and plans to enroll 494 participants.
• Yale University is sponsoring a Phase 1/2 study, NCT06963905, to assess the safety and efficacy of sacituzumab govitecan plus nivolumab or sacituzumab govitecan plus a fixed dose combination of nivolumab and relatlimab in patients with metastatic triple-negative breast cancer. This trial targets 60 participants.
• Duke University is leading the GIANT trial, NCT06816927, a Phase 2 study investigating nivolumab with or without relatlimab in patients with newly diagnosed glioblastoma. The study aims to enroll 92 participants.
• A translational study, NCT07223411, sponsored by John Kirkwood, is examining the immunological response in tumor and peripheral blood of 20 participants with unresectable or metastatic melanoma receiving Opdualag™ versus cemiplimab/fianlimab.
• The University of California, San Diego, is conducting a Phase 2 trial, NCT06624475, comparing neoadjuvant Opdualag™ (nivolumab + relatlimab) versus nivolumab alone for resectable high-risk basal cell carcinoma, with an enrollment target of 30 participants.
• Linnaeus Therapeutics, Inc. is sponsoring a Phase 2/3 trial, NCT06624644, of LNS8801 with or without pembrolizumab in 135 participants with refractory melanoma.
• Stanford University is conducting a Phase 2 trial, NCT06712927, of relatlimab, nivolumab, and ipilimumab in 60 patients with asymptomatic and symptomatic melanoma brain metastases.
• M.D. Anderson Cancer Center is sponsoring a Phase 2 trial, NCT06708949, comparing nivolumab, relatlimab, and ipilimumab versus nivolumab plus ipilimumab in 15 patients with first-line advanced renal cell carcinoma.
• Bristol-Myers Squibb is conducting a large Phase 1/2 study, NCT06697197, to test the safety and efficacy of BMS-986482 alone or in combination with other therapies in 413 participants with advanced solid tumors.
• Immatics US, Inc. is sponsoring a Phase 3 trial, NCT06743126, comparing SUPRAME-ACTengine® IMA203 to investigator's choice of treatment in 360 patients with previously treated, unresectable or metastatic cutaneous melanoma.
• A Phase 3 study, NCT06561386, sponsored by Bristol-Myers Squibb, is comparing the efficacy of nivolumab and relatlimab plus chemotherapy versus pembrolizumab plus chemotherapy for stage IV/recurrent non-squamous non-small cell lung cancer with PD-L1 expression ≥ 1%. This study aims to enroll 1000 participants.
• Regeneron Pharmaceuticals is sponsoring the Harmony Head-to-Head study, NCT06246916, a Phase 3 trial comparing fianlimab+cemiplimab with relatlimab+nivolumab in 560 adult participants with advanced or metastatic melanoma.
• The National Cancer Institute (NCI) is conducting a Phase 2 trial, NCT06029270, testing the addition of BMS-986016 (relatlimab) to usual immunotherapy after initial treatment for recurrent or metastatic nasopharyngeal cancer, with an enrollment target of 156 participants.
• Replimune, Inc. is sponsoring the IGNYTE-3 trial, NCT06264180, a Phase 3 study comparing VO and nivolumab versus physician's choice in 400 patients with advanced melanoma that progressed on anti-PD-1 and anti-CTLA-4 drugs.
• The Melanoma Institute Australia is also conducting a Phase 2 study, NCT06288191, on neoadjuvant nivolumab and relatlimab in 20 participants with cutaneous squamous cell carcinoma.
• Immunocore Ltd is sponsoring the PRISM-MEL-301 trial, NCT06112314, a Phase 3 study comparing IMC-F106C regimens versus nivolumab regimens in 680 previously untreated advanced melanoma patients.
• H. Lee Moffitt Cancer Center and Research Institute is conducting a Phase 2 study, NCT06295159, on neoadjuvant and adjuvant anti-PD1 or combinations for locoregionally advanced melanoma, aiming to enroll 90 participants.
• Another Phase 2 trial from the Melanoma Institute Australia, NCT06151236, is testing neoadjuvant nivolumab and relatlimab in 20 patients with Merkel cell carcinoma.
• The Netherlands Cancer Institute is sponsoring a Phase 2 trial, NCT06237920, randomizing pre-operative nivolumab with or without relatlimab in 90 patients with Stage II-IIIa urothelial cancer.
• The National Cancer Institute (NCI) is conducting the MODERN Study, NCT05987241, a Phase 2/3 trial examining the role of ctDNA in guiding immunotherapy after surgical removal of bladder, kidney, ureter, and urethra for urothelial cancer. This large study aims to enroll 992 participants.
• M.D. Anderson Cancer Center is sponsoring a Phase 2 study, NCT05704647, of nivolumab in combination with relatlimab in 30 patients with active melanoma brain metastases.
• NYU Langone Health is conducting a Phase 2 study, NCT05428007, of interleukin-6 receptor inhibitor sarilumab in combination with ipilimumab, nivolumab, and relatlimab in 105 patients with unresectable stage III or IV melanoma.
• Exelixis is sponsoring a Phase 1 study, NCT05176483, of zanzalintinib in combination with immuno-oncology agents, including nivolumab and relatlimab, in 1314 participants with solid tumors.
• Carlo Contreras is sponsoring a Phase 1 trial, NCT04697576, investigating intralesional influenza vaccine for the treatment of stage I-IV melanoma in 36 participants.
• The University Hospital, Essen, is sponsoring a Phase 2 study, NCT04205552, of neoadjuvant nivolumab combination treatment in 90 resectable non-small cell lung cancer patients, including a nivolumab/relatlimab arm.
• Bristol-Myers Squibb is sponsoring a large Phase 2 Pan Tumor Rollover Study, NCT03899155, examining the long-term safety of nivolumab monotherapy and combinations, including relatlimab, in 1500 participants with various tumor types.
• The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is conducting a Phase 2 study, NCT03521830, of nivolumab alone or plus relatlimab or ipilimumab for 57 patients with locally-advanced unresectable or metastatic basal cell carcinoma.
• Salzburger Landeskliniken is sponsoring a Phase 2 study, NCT04204837, of nivolumab alone or plus relatlimab for the treatment of squamous cell carcinoma of the skin in 61 patients.

Where to Participate

Clinical trials involving Relatlimab are widely accessible, with studies taking place across a broad geographic range. There are currently 848 sites in 448 cities across 49 states, making it possible for many patients to find a study nearby.

The cities with the highest number of recruiting sites include:

• Los Angeles, California (20 sites)
• New York, New York (17 sites)
• Philadelphia, Pennsylvania (15 sites)
• St Louis, Missouri (14 sites)
• Boston, Massachusetts (14 sites)
• Dallas, Texas (13 sites)
• Chicago, Illinois (12 sites)
• Pittsburgh, Pennsylvania (12 sites)
• Houston, Texas (11 sites)
• Columbus, Ohio (11 sites)

Eligibility criteria for these trials are generally inclusive, welcoming participants of all genders aged between 12 and 100 years. Some studies also include healthy volunteers and children, depending on the specific research goals.

Development Timeline

The journey of Relatlimab began on October 23, 2013, with the initiation of its first clinical trial. Since then, the development program has expanded significantly, encompassing a total of 90 trials and enrolling 25,158 participants to date, with the latest trial starting in 2026.

The primary driver behind Relatlimab's development has been Bristol-Myers Squibb, sponsoring 30 of these trials. Other notable sponsors include the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, M.D. Anderson Cancer Center, the National Cancer Institute (NCI), and the Melanoma Institute Australia, each contributing to the robust research pipeline.

Relatlimab's development has progressed through various phases, with a strong focus on later-stage research. The majority of trials are in Phase 2 (48 trials), followed by Phase 1/2 (12 trials) and Phase 1 (11 trials), indicating a mature and expanding research effort. There are also 8 Phase 3 trials and 2 Phase 4 trials, reflecting advanced stages of investigation.

Initially, the research for Relatlimab explored conditions like IBS-C and hyperphosphatemia. However, the focus quickly shifted and dramatically expanded to a wide array of cancers. The pipeline grew to include advanced melanoma, non-small cell lung cancer, cutaneous melanoma, and advanced solid tumors. This expansion continued to encompass conditions such as basal cell carcinoma, head and neck squamous cell carcinoma, hepatocellular carcinoma, various lymphomas, renal cell carcinoma, glioblastoma, and urothelial carcinoma, among many others. This broad exploration highlights Relatlimab's potential across a diverse spectrum of oncological indications, often in combination with other immunotherapies.