Cemiplimab clinical trials
Cemiplimab is named as an intervention in 69 current clinical trials in our USA, Spain, France, Italy, Australia, Canada, Germany, Turkey, Brazil, Netherlands, Poland, South Korea, Taiwan, Belgium, Israel, UK, Mexico, Ireland, Austria, Czechia, Japan, Switzerland, Singapore, China, Sweden and Egypt registers. 35 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Regeneron Pharmaceuticals (27). The most-studied condition is Melanoma. The EU clinical trials register (CTIS) separately lists 7 authorised or ongoing trials.
Where Cemiplimab is approved
All regulators →Of the three regulators tracked here, the first to approve Cemiplimab was the US, on 28 Sep 2018. It is approved in 3 of the 3 regulators tracked here.
- 1 EU safety letter (DHPC), latest: quality defect for Libtayo, 10 Nov 2025
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Cemiplimab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Cemiplimab works
All drug targets →- Programmed cell death protein 1 inhibitor InhibitorTarget: PDCD1 programmed cell death 1✓ In ChEMBL and the Guide to Pharmacology
- Cervical adenocarcinomaPhase 3
- Cervical squamous cell carcinomaPhase 3
- MelanomaPhase 3
- Metastatic malignant neoplasmPhase 3
- Metastatic melanomaPhase 3
- Non-small cell lung carcinomaPhase 3
- Merkel cell skin cancerPhase 2
- Adrenal cortex carcinomaPhase 2
- AngiosarcomaPhase 2
- Biliary tract cancerPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297723, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10090, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Cemiplimab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 7 technology appraisals of Cemiplimab. 7 are current, and 3 of these recommend it for at least some patients.
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Cemiplimab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: LibtayoEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-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
Trials by phase
Clinical trials of Cemiplimab
69 trialsRegisters 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.
Cemiplimab in the EU trials register (CTIS)
7 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Cemiplimab. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Cemiplimab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Cemiplimab on the HPRA medicines list.
- LIBTAYO 350 mg Concentrate for solution for infusionRegeneron Ireland U.C. · EU/1/19/1376/001
Supply shortages
No entry for Cemiplimab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Cemiplimab
88 conditionsAll 88 conditions
| Condition (as registered) | Trials |
|---|---|
| Melanoma | 7 |
| Cutaneous Squamous Cell Carcinoma | 4 |
| Non-Small Cell Lung Cancer | 3 |
| Non-small Cell Lung Cancer | 3 |
| Non Small Cell Lung Cancer | 3 |
| Fallopian Tube Cancer | 3 |
| Advanced Solid Tumors | 2 |
| Advanced Non-Small Cell Lung Cancer | 2 |
| Solid Tumor | 2 |
| Cutaneous Squamous Cell Carcinoma (CSCC) | 2 |
| Metastatic Cutaneous Squamous Cell Carcinoma | 2 |
| Ovarian Cancer | 2 |
| Primary Peritoneal Cancer | 2 |
| Carcinoma, Non-Small-Cell Lung | 2 |
| Head and Neck Squamous Cell Carcinoma | 2 |
| Metastatic Castration-Resistant Prostate Cancer (mCRPC) | 2 |
| Clear Cell Renal Cell Carcinoma (ccRCC) | 2 |
| Advanced Solid Tumor | 2 |
| NSCLC | 2 |
| Immunotherapy | 2 |
| Metastatic Solid Tumor | 2 |
| Recurrent Ovarian Cancer | 1 |
| Recurrent Fallopian Tube Cancer | 1 |
| Recurrent Primary Peritoneal Cancer | 1 |
| Recurrent Endometrial Cancer | 1 |
| Non-small Cell Lung Cancer (NSCLC) | 1 |
| Plasma Cell Myeloma | 1 |
| Advanced Cutaneous Squamous Cell Carcinoma | 1 |
| Head and Neck Squamous Cell Carcinoma (HNSCC) | 1 |
| Brain Tumor | 1 |
| Epithelial Ovarian Cancer | 1 |
| Primary Peritoneal Carcinoma | 1 |
| Colo-rectal Cancer | 1 |
| Solid Tumor, Adult | 1 |
| Relapsed Cancer | 1 |
| Refractory Cancer | 1 |
| Resectable Non-small Cell Lung Cancer | 1 |
| Recurrent Head and Neck Squamous Cell Carcinoma | 1 |
| Metastatic Head-and-neck Squamous-cell Carcinoma | 1 |
| Locally Advanced Cutaneous Squamous Cell Carcinoma | 1 |
| Clear-Cell Renal-Cell Carcinoma (ccRCC) | 1 |
| Glioblastoma | 1 |
| Cancer | 1 |
| Tumor, Solid | 1 |
| Malignant Neoplasm | 1 |
| Metastatic Cancer | 1 |
| Multiple Myeloma | 1 |
| Triple Negative Breast Cancer | 1 |
| Diffuse Large B Cell Lymphoma | 1 |
| Follicular Lymphoma | 1 |
| Lymphoma, Non-Hodgkin | 1 |
| Advanced Non-small Cell Lung Cancer | 1 |
| Cutaneous Tumor | 1 |
| Subcutaneous Tumor | 1 |
| Malignant Solid Tumor | 1 |
| Hepatocellular Carcinoma | 1 |
| Endometrial Cancer | 1 |
| Basal Cell Carcinoma (BCC) | 1 |
| First Line Treatment | 1 |
| Pleural Mesotheliomas | 1 |
| Non Small Cell Lung Cancer (Squamous or Non Squamous) | 1 |
| Stage III NSCLC | 1 |
| NSCLC Stage IV | 1 |
| NSCLC (Advanced Non-small Cell Lung Cancer) | 1 |
| Melanoma BRAF V600E/K Mutated | 1 |
| Melanoma and Brain Metastases | 1 |
| Cutaneous Basal Cell Carcinoma | 1 |
| Non Small Cell Lung Cancer Metastatic | 1 |
| Lung Diseases | 1 |
| Stage IV Non-small Cell Lung Cancer | 1 |
| Stage III Non-small Cell Lung Cancer | 1 |
| Unspecified Adult Solid Tumor, Protocol Specific | 1 |
| Adrenal Cortical Carcinoma | 1 |
| Advanced Squamous Non-Small Cell Lung Cancer | 1 |
| Carcinoma, Non-Small -Cell Lung | 1 |
| Metastatic NSCLC - Non-Small Cell Lung Cancer | 1 |
| Neoadjuvant Therapy | 1 |
| Vulvar Cancers | 1 |
| Penile Cancer | 1 |
| Recurrent Lung Non-Small Cell Carcinoma | 1 |
| Stage IV Lung Cancer AJCC v8 | 1 |
| Advanced Malignancies | 1 |
| Cutaneous Squamous Cell Carcinoma of the Head and Neck | 1 |
| Neoplasms | 1 |
| Non-melanoma Skin Cancer | 1 |
| Pancreatic Cancer | 1 |
| Adenocarcinoma of the Pancreas | 1 |
| Adenocarcinoma | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Regeneron Pharmaceuticals | 27 |
| Biohaven Therapeutics Ltd | 2 |
| Maia Biotechnology | 2 |
| Intergroupe Francophone de Cancerologie Thoracique | 2 |
| The Netherlands Cancer Institute | 2 |
| Hospital Israelita Albert Einstein | 2 |
| ETOP IBCSG Partners Foundation | 1 |
| BioNTech SE | 1 |
| Servier Bio-Innovation LLC | 1 |
| Sanofi | 1 |
| Replimune, Inc | 1 |
| InSightec | 1 |
| Vyriad, Inc | 1 |
| HotSpot Therapeutics, Inc | 1 |
| Rakuten Medical, Inc | 1 |
+ 23 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Cemiplimab trials
How many clinical trials are testing Cemiplimab?
69 current trials in our USA, Spain, France, Italy, Australia, Canada, Germany, Turkey, Brazil, Netherlands, Poland, South Korea, Taiwan, Belgium, Israel, UK, Mexico, Ireland, Austria, Czechia, Japan, Switzerland, Singapore, China, Sweden and Egypt registers name Cemiplimab (also registered as REGN2810) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Cemiplimab trials recruiting patients?
Yes. 35 of the 69 trials are recruiting: 18 with sites in USA, 11 with sites in Spain, 9 with sites in France, 5 with sites in Italy, 5 with sites in Australia, 5 with sites in Canada, 3 with sites in Germany, 3 with sites in Turkey, 1 with sites in Brazil, 2 with sites in Netherlands, 3 with sites in Poland, 4 with sites in South Korea, 2 with sites in Taiwan, 3 with sites in Belgium, 2 with sites in Israel, 2 with sites in UK, 2 with sites in Mexico, 1 with sites in Ireland, 1 with sites in Austria, 2 with sites in Switzerland, 1 with sites in Singapore and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Cemiplimab clinical trials?
Regeneron Pharmaceuticals (27), Biohaven Therapeutics Ltd (2), Maia Biotechnology (2) and Intergroupe Francophone de Cancerologie Thoracique (2), among 38 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Cemiplimab clinical trials in Ireland?
Yes. 5 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.
Is Cemiplimab licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Cemiplimab, for example LIBTAYO 350 mg Concentrate for solution for infusion (Regeneron Ireland U.C.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Cemiplimab shortage?
Not in the lists we track: Cemiplimab has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
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 Cemiplimab works or whether it is effective, and it is not medical advice.
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 Cemiplimab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Cemiplimab (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.