Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Fianlimab clinical trials

Also listed in trial records as REGN3767
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 14 trials in our USA, Spain, Canada, France, Turkey, Australia, Germany, Italy, Mexico, Israel, South Korea, Taiwan, Ireland, UK, Belgium, Poland, Austria, Czechia, Brazil, Netherlands and Japan registers that name Fianlimab as an intervention. Synced 9 Nov 2026
14Current trials
5Recruiting now
3Lead sponsors
21Country registers
At a glance

Fianlimab is named as an intervention in 14 current clinical trials in our USA, Spain, Canada, France, Turkey, Australia, Germany, Italy, Mexico, Israel, South Korea, Taiwan, Ireland, UK, Belgium, Poland, Austria, Czechia, Brazil, Netherlands and Japan registers. 5 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Regeneron Pharmaceuticals (12). The most-studied condition is Melanoma.

How Fianlimab works

All drug targets →
  • Lymphocyte activation gene 3 protein inhibitor Inhibitor
    Target: LAG3 lymphocyte activating 3
    ✓ In ChEMBL and the Guide to Pharmacology
Other medicines acting on LAG3
Diseases it has been tested for in clinical trials, by furthest phase
  • MelanomaPhase 3
  • Non-small cell lung carcinomaPhase 2/3
  • Basal cell carcinomaPhase 2
  • Clear cell renal carcinomaPhase 2
  • Colon carcinomaPhase 2
  • Colorectal cancerPhase 2
  • Cutaneous squamous cell carcinomaPhase 2
  • Head and neck cancerPhase 2
  • Head and neck squamous cell carcinomaPhase 2
  • Hepatocellular carcinomaPhase 2
23 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4298085, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 14532, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Fianlimab

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting536%
  • Active, closed857%
  • By invitation17%

Trials by phase

  • Phase 2750%
  • Phase 3321%
  • Phase 2/3214%
  • Phase 1214%
01

Clinical trials of Fianlimab

14 trials
StudyPhaseStatusLead sponsorRegisters
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
NCT06246916 · Melanoma
Phase 3 Recruiting Regeneron Pharmaceuticals USA, Canada
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
NCT06787612 · ClinicalTrials.gov ↗ · Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Phase 2 Recruiting Regeneron Pharmaceuticals USA, Turkey, Canada, South Korea, Taiwan
Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases
NCT06887088 · ClinicalTrials.gov ↗ · Melanoma BRAF V600E/K Mutated, Melanoma and Brain Metastases
Phase 2 Recruiting Grupo Español Multidisciplinar de Melanoma Spain
Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma
NCT07234058 · ClinicalTrials.gov ↗ · Pleural Mesotheliomas
Phase 2 Recruiting Intergroupe Francophone de Cancerologie Thoracique France
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
NCT05137054 · Multiple Myeloma
Phase 1 Recruiting Regeneron Pharmaceuticals USA, France, Spain, Israel
A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment
NCT06848088 · Melanoma
Phase 2 By invitation Regeneron Pharmaceuticals Ireland, USA
Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
NCT05352672 · Melanoma
Phase 3 Active, closed Regeneron Pharmaceuticals Ireland, UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Austria, Czechia, Turkey, Canada, Brazil, Mexico, Australia
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
NCT05608291 · Melanoma
Phase 3 Active, closed Regeneron Pharmaceuticals Ireland, UK, USA, Germany, France, Spain, Italy, Belgium, Poland, Czechia, Turkey, Canada, Brazil, Mexico, Australia, Israel
A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT05785767 · Advanced Non-Small Cell Lung Cancer
Phase 2/3 Active, closed Regeneron Pharmaceuticals USA, Spain, Turkey, Canada, Mexico, South Korea, Taiwan, Australia, Israel
A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer
NCT05800015 · Non-small Cell Lung Cancer
Phase 2/3 Active, closed Regeneron Pharmaceuticals USA, Turkey, Canada, Mexico, South Korea, Taiwan, Australia, Israel
Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients
NCT03916627 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Head and Neck Squamous Cell Carcinoma
Phase 2 Active, closed Regeneron Pharmaceuticals USA
A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery
NCT06161441 · Resectable Non-small Cell Lung Cancer
Phase 2 Active, closed Regeneron Pharmaceuticals USA, Germany, France, Spain, Italy, Turkey, South Korea, Taiwan, Australia
A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
NCT06190951 · Melanoma
Phase 2 Active, closed Regeneron Pharmaceuticals USA, Germany, France, Spain, Italy, Austria, Canada, Australia
Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies
NCT03233139 · ClinicalTrials.gov ↗ · Advanced Malignancies
Phase 1 Active, closed Regeneron Pharmaceuticals Japan

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Fianlimab

14 conditions
All 14 conditions
Condition (as registered)Trials
Melanoma5
Non-small Cell Lung Cancer2
Advanced Non-Small Cell Lung Cancer1
Ovarian Cancer1
Fallopian Tube Cancer1
Primary Peritoneal Cancer1
Resectable Non-small Cell Lung Cancer1
Multiple Myeloma1
Hepatocellular Carcinoma1
Head and Neck Squamous Cell Carcinoma1
Pleural Mesotheliomas1
Melanoma BRAF V600E/K Mutated1
Melanoma and Brain Metastases1
Advanced Malignancies1
05

Related compounds

06

Questions about Fianlimab trials

How many clinical trials are testing Fianlimab?

14 current trials in our USA, Spain, Canada, France, Turkey, Australia, Germany, Italy, Mexico, Israel, South Korea, Taiwan, Ireland, UK, Belgium, Poland, Austria, Czechia, Brazil, Netherlands and Japan registers name Fianlimab (also registered as REGN3767) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Fianlimab trials recruiting patients?

Yes. 5 of the 14 trials are recruiting: 3 with sites in USA, 2 with sites in Spain, 2 with sites in Canada, 2 with sites in France, 1 with sites in Turkey, 1 with sites in Israel, 1 with sites in South Korea and 1 with sites in Taiwan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Fianlimab clinical trials?

Regeneron Pharmaceuticals (12), Intergroupe Francophone de Cancerologie Thoracique (1) and Grupo Español Multidisciplinar de Melanoma (1). The number in brackets is how many trials each organisation leads.

Are there Fianlimab clinical trials in Ireland?

Yes. 3 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Fianlimab works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Fianlimab works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Fianlimab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.