Drugs / Relatlimab
Relatlimab
also known as
BMS 986016 · BMS-986213 · Opdualag · Relatlimab-rmbw · Nivolumab-relatlimab · Nivolumab-relatlimab FDC · rela · Relatilmab · +3 more
Monoclonal antibody targets LAG3
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Opdualag | — | 2022-09-15 | europa.eu ↗ |
| Approved | US (FDA) | OPDUALAG | — | 2022-03-18 | fda.gov ↗ |
Trials 89 · started per year
today
US approved 2022
EU approved 2022
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05704933 | Jun 2023 → Jun 2024 | metastatic malignant neoplasm in the brain, metastatic melanoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 111 trials | ||||||
| Phase 1 | NCT05498480 | Jul 2022 → Jan 2024 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT05176483 | Dec 2021 → Jun 2030 expected | castration-resistant prostate carcinoma, clear cell renal carcinoma, colorectal carcinoma, head and neck squamous cell carcinoma +3 | Exelixis | Recruiting | No outcome recorded |
| Phase 1 | NCT03978611 | Dec 2021 → Jul 2023 | melanoma | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 1 | NCT04935229 | Aug 2021 → Jul 2024 | uveal melanoma | TriSalus Life Sciences, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT04658147 | May 2021 → Sep 2025 overdue | hepatocellular carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04112498 | Oct 2019 → Feb 2023 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03493932 | Sep 2018 → Apr 2023 | glioblastoma | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 1 | NCT03335540 | May 2018 → Mar 2021 | cancer of unknown primary site | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03044613 | Jul 2017 → Mar 2027 expected | esophageal cancer, gastric cancer, gastroesophageal cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02966548 | Jan 2017 → Jul 2024 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02658981 | Aug 2016 → Apr 2022 | gliosarcoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 1/216 trials | ||||||
| Phase 1/2 | NCT07281924 | Jul 2026 → Dec 2030 expected | metastatic melanoma | University of Wisconsin, Madison | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06683755 | May 2025 → Aug 2030 expected | melanoma | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06697197 | Feb 2025 → Jan 2029 expected | cancer | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06208657 | Jul 2024 → Dec 2030 expected | brain cancer, childhood malignant neoplasm, refractory malignant neoplasm | Australian & New Zealand Children's Haematology/Oncology Group | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05970497 | Oct 2023 → Jul 2027 expected | cutaneous melanoma | Krystal Biotech, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05255601 | Sep 2022 → Dec 2025 | Hodgkins lymphoma, non-Hodgkin lymphoma | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 1/2 | NCT05337137 | May 2022 → Jul 2025 | hepatocellular carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT05134948 | Nov 2021 → Sep 2025 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT04611126 | Apr 2021 → Mar 2024 | fallopian tube cancer, ovarian cancer, peritoneal carcinoma | Inge Marie Svane | Terminated | No outcome recorded |
| Phase 1/2 | NCT04150965 | Jul 2020 → Aug 2024 | plasma cell myeloma, refractory plasma cell neoplasm | Multiple Myeloma Research Consortium | Terminated | No outcome recorded |
| Phase 1/2 | NCT03610711 | Mar 2019 → Dec 2026 expected | gastroesophageal cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03459222 | May 2018 → Feb 2025 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT03310619 | Dec 2017 → Feb 2023 | diffuse large B-cell lymphoma, follicular lymphoma | Celgene Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT02488759 | Oct 2015 → Mar 2021 | cancer of unknown primary site | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT02061761 | Mar 2014 → Feb 2022 | hematopoietic and lymphoid cell neoplasm | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT01968109 | Nov 2013 → May 2024 | neoplasm | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 253 trials | ||||||
| Phase 2 | NCT07644312 | Mar 2027 → Mar 2033 expected | DNA repair disease, diffuse intrinsic pontine glioma, grade III glioma | Nationwide Children's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07369791 | Dec 2026 → Dec 2035 | biliary tract cancer | National Health Research Institutes, Taiwan | Withdrawn | No outcome recorded |
| Phase 2 | NCT06319196 | Aug 2026 → Feb 2027 expected | cutaneous melanoma, mucosal melanoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT06999980 | Feb 2026 → Mar 2028 expected | cutaneous melanoma, mucosal melanoma | Melanoma Institute Australia | Recruiting | No outcome recorded |
| Phase 2 | NCT06816927 | Nov 2025 → Jun 2029 expected | glioblastoma | Duke University | Recruiting | No outcome recorded |
| Phase 2 | NCT06624475 | Aug 2025 → May 2028 expected | basal cell carcinoma | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 2 | NCT06712927 | Aug 2025 → Nov 2026 expected | melanoma, metastatic malignant neoplasm in the brain | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT06708949 | Mar 2025 → Dec 2026 expected | clear cell renal carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06715241 | Dec 2024 → Dec 2030 expected | cervical carcinoma | ARCAGY/ GINECO GROUP | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06325683 | Nov 2024 → Jul 2028 | glioblastoma | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 2 | NCT06029270 | Jul 2024 → Apr 2029 expected | nasopharyngeal carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06288191 | Jun 2024 → Sep 2026 expected | skin squamous cell carcinoma | Melanoma Institute Australia | Recruiting | No outcome recorded |
| Phase 2 | NCT06295159 | May 2024 → Nov 2028 expected | melanoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06151236 | Mar 2024 → Dec 2026 expected | cutaneous neuroendocrine carcinoma | Melanoma Institute Australia | Recruiting | No outcome recorded |
| Phase 2 | NCT06237920 | Feb 2024 → Dec 2026 expected | poisoning, urinary bladder carcinoma, urothelial carcinoma | The Netherlands Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06101134 | Nov 2023 → Apr 2025 overdue | melanoma | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05418972 | Aug 2023 → Dec 2025 overdue | melanoma | Melanoma Institute Australia | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05912244 | Jun 2023 → Jun 2027 expected | melanoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05704647 | Feb 2023 → Jul 2028 expected | cutaneous melanoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05347212 | Sep 2022 → Jul 2027 expected | kidney medullary carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05148546 | Apr 2022 → Apr 2025 overdue | renal cell carcinoma | The Netherlands Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06400264 | Feb 2022 → Jan 2023 | adult lymphoma, plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 2 | NCT05034536 | Feb 2022 → Jun 2026 overdue | metastatic melanoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04953104 | Sep 2021 → Dec 2026 expected | bladder transitional cell carcinoma, renal pelvis urothelial carcinoma, ureter transitional cell carcinoma, urethra transitional cell carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05077280 | Sep 2021 → Mar 2024 | uveal melanoma | California Pacific Medical Center Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT04913922 | May 2021 → Mar 2025 | acute myeloid leukemia | Ludwig-Maximilians - University of Munich | Unknown | No outcome recorded |
| Phase 2 | NCT04623775 | Feb 2021 → Jan 2024 | non-small cell lung carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT04567615 | Feb 2021 → Aug 2023 | adult hepatocellular carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT04552223 | Nov 2020 → Jan 2024 | uveal melanoma | Jose Lutzky, MD | Completed | No outcome recorded |
| Phase 2 | NCT04326257 | May 2020 → Aug 2023 | head and neck squamous cell carcinoma | Dan Zandberg | Completed | No outcome recorded |
| Phase 2 | NCT04205552 | Mar 2020 → Nov 2025 | non-small cell lung carcinoma | University Hospital, Essen | Completed | No outcome recorded |
| Phase 2 | NCT04095208 | Feb 2020 → Sep 2024 | soft tissue sarcoma | Institut Bergonié | Completed | No outcome recorded |
| Phase 2 | NCT04080804 | Dec 2019 → Oct 2027 expected | head and neck squamous cell carcinoma | Dan Zandberg | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03704077 | Oct 2019 → Feb 2022 | gastric carcinoma, gastroesophageal junction adenocarcinoma | Bristol-Myers Squibb | Withdrawn | No outcome recorded |
| Phase 2 | NCT04062656 | Sep 2019 → Mar 2024 | gastric cancer, gastroesophageal junction adenocarcinoma | University Hospital, Essen | Unknown | No outcome recorded |
| Phase 2 | NCT03899155 | Aug 2019 → Aug 2029 expected | cancer | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 2 | NCT03645928 | May 2019 → Feb 2026 | head and neck squamous cell carcinoma, metastatic melanoma, non-small cell lung carcinoma | Iovance Biotherapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03623854 | Apr 2019 → Sep 2023 | chordoma | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03743766 | Mar 2019 → Jul 2024 | melanoma | John Kirkwood | Completed | No outcome recorded |
| Phase 2 | NCT03867799 | Mar 2019 → Oct 2022 | colorectal cancer | Royal Marsden NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 2 | NCT03642067 | Feb 2019 → Feb 2024 | colorectal adenocarcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT03724968 | Jan 2019 → May 2020 | metastatic melanoma | Elizabeth Davis | Terminated | No outcome recorded |
| Phase 2 | NCT03521830 | Nov 2018 → Jul 2027 expected | basal cell carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT03607890 | Nov 2018 → Oct 2026 expected | refractory malignant neoplasm | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03662659 | Oct 2018 → Aug 2020 | gastric cancer, gastroesophageal junction adenocarcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT03026140 | Mar 2017 → Mar 2032 expected | colon carcinoma | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04204837 | Mar 2017 → Dec 2026 expected | skin squamous cell carcinoma | Salzburger Landeskliniken | Recruiting | No outcome recorded |
| Phase 2 | NCT02996110 | Feb 2017 → Nov 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT02935634 | Nov 2016 → May 2022 | gastric cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT02750514 | May 2016 → Jan 2020 | cancer of unknown primary site | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 2 | NCT02519322 | Feb 2016 → Jan 2023 | acral lentiginous melanoma, mucosal melanoma, uveal melanoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2026 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02060188 | Mar 2014 → Oct 2024 | colorectal cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05987241 | Feb 2024 → Sep 2030 expected | infiltrating bladder urothelial carcinoma, infiltrating renal pelvis/ureter urothelial carcinoma, urethra transitional cell carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03470922 | Apr 2018 → Jan 2021 overdue | melanoma | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06561386 | Oct 2024 → Jul 2030 expected | non-small cell lung carcinoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT05625399 | Mar 2023 → Aug 2025 overdue | melanoma | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05328908 | Apr 2022 → Jul 2025 | colorectal neoplasm | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 3 | NCT05002569 | Oct 2021 → Dec 2024 | melanoma | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07459543 | Nov 2026 → May 2029 expected | metastatic melanoma | Bristol-Myers Squibb | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07574047 | Sep 2026 → Jun 2030 expected | melanoma | Swiss Cancer Institute | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 12 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05629546 Background | Nov 2024 → Feb 2029 expected | metastatic melanoma | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT04697576 Background | Oct 2021 → Sep 2027 expected | cutaneous melanoma, metastatic melanoma | Carlo Contreras | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06963905 Comparator | Dec 2025 → Dec 2030 expected | triple-negative breast carcinoma | Yale University | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05428007 Background | Feb 2023 → Aug 2026 overdue | melanoma | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06624644 Comparator | Aug 2025 → Feb 2029 expected | cutaneous melanoma | Linnaeus Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06743126 Comparator | Jan 2025 → Jan 2028 expected | cutaneous melanoma | Immatics US, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06246916 Comparator | Sep 2024 → Mar 2027 expected | melanoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06264180 Comparator | Jul 2024 → Sep 2030 expected | melanoma | Replimune, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06112314 Comparator | Jun 2024 → Oct 2027 expected | melanoma | Immunocore Ltd | Recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07504796 Background | Apr 2026 → May 2029 expected | metastatic melanoma | NYU Langone Health | Recruiting | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT05170659 Background | — | — | Bristol-Myers Squibb | No longer available | No outcome recorded |
| — | NCT05170685 Background | — | — | Bristol-Myers Squibb | No longer available | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2022-03-18 | Bristol-Myers Squibb | U.S. Food and Drug Administration Approves First LAG-3-Blocking Antibody Combination, Opdualag™ (nivolumab and relatlimab-rmbw), as Treatment for Patients with Unresectable or Metastatic Melanoma bms.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 103 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Relatlimab | “Opdualag, a fixed-dose combination of Nivolumab 480mg and Relatlimab 160mg, intravenous, on day 1, 28 day cycle, 26 cycles” NCT06208657 ↗87“Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years” NCT05077280 ↗ “Nivolumab 480 mg and relatlimab 160 mg administered intravenously every 4 weeks (Q4W)” NCT07574047 ↗ “Nivolumab 480mg and Relatlimab 160mg will be administered intravenously every 4 weeks” NCT03867799 ↗ “Fixed dose combination of relatlimab and nivolumab (Opdualag)” NCT07644312 ↗ “Nivolumab + Relatlimab Fixed-Dose Combination (FDC)” NCT07459543 ↗ “Relatlimab (Anti-LAG-3 Monoclonal Antibody)” NCT05134948 ↗ |
| Known as | BMS 986016 | “Nivolumab and BMS-986016 (Relatlimab) as Potentially Targeting Treatment” NCT06400264 ↗9“Biological: Anti-LAG-3 Monoclonal Antibody BMS 986016” NCT02658981 ↗ “Relatlimab (BMS-986016) With Nivolumab (BMS-936558)” NCT04913922 ↗ “anti-LAG-3 monoclonal antibody BMS-986016” NCT02658981 ↗ “Anti-LAG-3 (BMS-986016)” NCT04150965 ↗ “BMS986016” NCT06029270 ↗ |
| Known as | BMS-986213 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06708949 ↗ |
| Known as | Nivolumab-relatlimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03645928 ↗ |
| Known as | Nivolumab-relatlimab FDC | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05328908 ↗ |
| Known as | Opdualag | “Opdualag” NCT03645928 ↗ |
| Known as | rela | “This is a multicenter, phase II trial of relatlimab (rela), nivolumab (nivo), and ipilimumab (ipi) in patients with asymptomatic and symptomatic melanoma brain metastases.” NCT06712927 ↗ |
| Known as | Relatilmab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05629546 ↗ |
| Known as | Relatlimab component of bms-986213 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990044 ↗ |
| Known as | Relatlimab component of opdualag -rmbw | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990044 ↗ |
| Known as | Relatlimab-rmbw | “Opdualag (Nivolumab and Relatlimab-rmbw) is a combination formulation composed of nivolumab, a human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative...” NCT06295159 ↗1“Opdualag (Nivolumab and Relatlimab-rmbw) is a human monoclonal antibody to LAG-3, currently under investigation.” NCT05704933 ↗ |
| Known as | Relatlimab: BMS-986016 | “Relatlimab: BMS-986016” NCT04326257 ↗ |
| Action | Inhibit | “relatlimab (anti-lymphocyte-activation gene 3 (LAG-3))” PMID 40010775 ↗ Feb 2025 |
| Modality | Monoclonal antibody | “Anti-LAG-3 Monoclonal Antibody (Relatlimab, BMS-986016)” NCT02061761 ↗ |
| Route | Intravenous | “relatlimab IV over 30 minutes” NCT02465060 ↗ |
| Target | LAG3 | “relatlimab (anti-lymphocyte-activation gene 3 (LAG-3))” PMID 40010775 ↗ Feb 2025 |