Libtayo

(Cemiplimab)

Phase 3Monoclonal antibody

Cemiplimab is used to treat certain types of skin cancer, including cutaneous squamous cell carcinoma and melanoma. It works by helping the immune system recognize and fight cancer cells.[1] Libtayo is currently being investigated across 63 indications[3], with its most advanced program in Phase 3.[1]

Libtayo is one of 958 biologic programs targeting Melanoma. It is currently in Phase 3.

Indications

183

Total Trials

136

Active Trials

957

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MelanomaActive, not recruiting

Squamous Cell CarcinomaSuspended

Non-Small Cell Lung CancerRecruiting

Advanced NSCLCActive, not recruiting

Metastatic Skin Squamous Cell CarcinomaActive, not recruiting

Advanced MalignanciesCompleted

Erectile DysfunctionActive, not recruiting

NSCLC Stage IVActive, not recruiting

Merkel Cell Carcinoma, Stage IRecruiting

Locally Recurrent Oral Cavity Squamous Cell CarcinomaRecruiting

MelanomaPhase 3

Active, not recruiting

Squamous Cell CarcinomaPhase 3

Suspended

Non-Small Cell Lung CancerPhase 3

Recruiting

Advanced NSCLCPhase 2

Active, not recruiting

Metastatic Skin Squamous Cell CarcinomaPhase 1

Active, not recruiting

Advanced MalignanciesPhase 1

Completed

Erectile DysfunctionPreclinical

Active, not recruiting

NSCLC Stage IVPhase 2

Active, not recruiting

Merkel Cell Carcinoma, Stage IPhase 2

Recruiting

Locally Recurrent Oral Cavity Squamous Cell CarcinomaPhase 2

Recruiting

Showing 10 of 63 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Libtayo

Regeneron

Phase 3

2 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 7

Duragesic-100

CCephalon

Preclinical

2 8

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 9

Spravato

WWim Janssens

Preclinical

2 10

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Melanoma

NCT04291105

Phase 1/2Active, not recruiting

Pd-1antibody

NCT05662397

Phase 2Active, not recruiting

Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8

NCT04862650

Q1 2027

Phase 1/2Recruiting

Prostate Cancer

NCT05125016

Phase 2Recruiting

Breast Cancer

NCT06860815

Phase 1/2Recruiting

Monoclonal

NCT06090266

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer17 trials

Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Terminated· Regeneron logo

Regeneron·Phase 1·NCT03580694·17 enrolled

A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)

Active, not recruiting· Regeneron logo

Regeneron·Phase 2·NCT05557591·51 enrolled

Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab Versus Best Investigator's Choice in Patients With Resistance to Treatment Due to Antibiotics Uptake With Advanced Non-small Cell Lung Cancer

Not yet recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT07001618·162 enrolled

Show 14 more trials

Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer

Recruiting·NNitin Ohri·Phase 2·NCT06865339·76 enrolled

Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy

Recruiting·EEmory University·Phase 2·NCT06731270·20 enrolled

Cemiplimab for the Treatment of Untreated Brain Metastases From PD-L1 >= 50% Non-Small Cell Lung Cancer

Withdrawn·—·Phase 2·NCT05840770

A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients With Resectable Non-Small Cell Lung Cancer

Active, not recruiting· Regeneron logo

Regeneron·Phase 2·NCT06465329·184 enrolled

An Observational Study to Assess the Effectiveness and Safety of Cemiplimab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)

Active, not recruiting· Regeneron logo

Regeneron··NCT05363319·509 enrolled

A Randomised Phase III Trial of Adjuvant Cemiplimab in Patients With Resected Stage II-IIIA NSCLC Who Have Not Received Prior Adjuvant Chemotherapy

Recruiting·EETOP IBCSG Partners Foundation·Phase 3·NCT06931717·390 enrolled

Safety, Efficacy, and Tumor Immune Microenvironment Changes With Neoadjuvant Chemotherapy and Cemiplimab With or Without Alirocumab in Stage 1B-3A Non-Small Cell Lung Cancer: TOP 2301

Recruiting·DDuke University·Phase 2·NCT06385262·63 enrolled

RADICAL-IO: thRee Cycles of immunotherApy Without raDical Therapy In mediCALly InOperable Stage I Non-small Cell Lung Cancer

Not yet recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT07808138·30 enrolled

An Open Label, Multicenter, Phase 1b/2a Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of the ATR Inhibitor M1774 in Combination With Cemiplimab in Participants With Non-Squamous Non-Small Cell Lung Cancer That Has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies (DDRiver NSCLC 322)

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Preclinical·NCT05882734·61 enrolled

Phase I/II Study of Combined Treatment With Cemiplimab (Anti-PD-1) and Dupilumab (Anti-IL-4R) in Patients With Early-stage, Resectable NSCLC

Recruiting·CCentre hospitalier de l'Université de Montréal (CHUM)·Preclinical·NCT06743581·24 enrolled

Neoadjuvant Chemo-Cemiplimab for Clinical Stage I, 2-3.9cm, Non-Small Cell Lung Cancer

Not yet recruiting·MMedical University of South Carolina·Phase 2·NCT07720167·38 enrolled

LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

Recruiting· BioNTech logo

BioNTech·Phase 1·NCT05142189·320 enrolled

A Phase 1/2 Study of Combined Treatment With Dupilumab (Anti-IL-4Ra) and Cemiplimab (Anti-PD-1) in Patients With Early-stage, Resectable NSCLC

Recruiting·IIcahn School of Medicine at Mount Sinai·Preclinical·NCT06088771·21 enrolled

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

Active, not recruiting· Regeneron logo

Regeneron·Preclinical·NCT05800015·160 enrolled

Cutaneous Squamous Cell Carcinoma9 trials

Expanded Access Protocol for Cemiplimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

No longer available· Regeneron logo

Regeneron··NCT03492489

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

Active, not recruiting· Regeneron logo

Regeneron·Phase 3·NCT03969004·415 enrolled

Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors

Terminated·EExicure, Inc.·Phase 1/2·NCT03684785·57 enrolled

Show 6 more trials

Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma

Completed· Regeneron logo

Regeneron·Phase 2·NCT04154943·79 enrolled

Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

Withdrawn· Regeneron logo

Regeneron·Phase 2·NCT06384820

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Completed· Regeneron logo

Regeneron·Phase 2·NCT02760498·432 enrolled

Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

Completed· Regeneron logo

Regeneron·Phase 1·NCT03889912·97 enrolled

Feasibility Study of Cemiplimab and Quad Shot Radiation in Elderly, Frail, or High Comorbidity Patients With Locally Advanced Cutaneous Squamous Cell Carcinomas of the Skin Arising in the Head and Neck Region

Recruiting·VVanderbilt-Ingram Cancer Center·Phase 1·NCT07869823·25 enrolled

Comprehensive and Deep Profiling in Cutaneous Squamous Cell Carcinomas to Unravel Treatment Efficacy in Immunotherapy Treated Patients

Active, not recruiting·PPeter MacCallum Cancer Centre, Australia·Phase 2·NCT05878288·11 enrolled

Skin Cancer5 trials

Next-gen Flow Cytometry to Find Immune Profiles, Treatment Response, and Toxicity Markers in Skin Cancer Patients Treated With Cemiplimab.

Recruiting·IInstituto de Investigación Biomédica de Salamanca··NCT07064330·30 enrolled

A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer

Active, not recruiting·UUniversity of Southern California·Phase 2·NCT04315701·35 enrolled

A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)

Terminated· Sanofi logo

Sanofi·Phase 1/2·NCT04913220·46 enrolled

Show 2 more trials

Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

Active, not recruiting·RReplimune Inc.·Phase 2·NCT04050436·231 enrolled

A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05574101·34 enrolled

Melanoma5 trials

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

Active, not recruiting· Regeneron logo

Regeneron·Phase 2·NCT06190951·151 enrolled

A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment

Completed· BioNTech logo

BioNTech·Phase 2·NCT04526899·184 enrolled

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT06246916·560 enrolled

Show 2 more trials

Phase 2 Trial of Voyager VI (Vesicular Stomatitis Virus Expressing NIS and Human Interferon Beta, VV1), in Combination With Cemiplimab in Patients With Select Solid Tumors

Active, not recruiting·VVyriad, Inc.·Phase 2·NCT04291105·87 enrolled

A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma

Active, not recruiting· Regeneron logo

Regeneron·Phase 3·NCT05608291·1,564 enrolled

Squamous Cell Carcinoma5 trials

A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck

Not yet recruiting·UUniversity of Chicago·Phase 2·NCT07346196·90 enrolled

Neoadjuvant Plus Adjuvant Treatment With Cemiplimab in Cutaneaous Squamous Cell Carcinoma

Active, not recruiting·UUnknown Sponsor·Phase 2·NCT04632433·25 enrolled

Study of Cemiplimab - TP Induction Chemotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Enrolling by invitation·KKrzysztof Misiukiewicz·Phase 1·NCT05376553·24 enrolled

Show 2 more trials

Randomized Phase III Trial of Neoadjuvant Immunotherapy With Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (C-PRE)

Suspended·NNational Cancer Institute (NCI)·Phase 3·NCT06568172·420 enrolled

Neoadjuvant Chemotherapy With or Without Cemiplimab (REGN2810) in Sinonasal Squamous Cell Carcinoma: A Randomized Phase 2 Study

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07281417·108 enrolled

109 more indications

Prostate Cancer4 trials

A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer

Recruiting· Regeneron logo

Regeneron·Phase 1/2·NCT05125016·370 enrolled

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

Terminated· BioNTech logo

BioNTech·Phase 1/2·NCT04382898·75 enrolled

Phase I/II Trial of Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer

Active, not recruiting·UUniversity of Wisconsin, Madison·Preclinical·NCT04989946·57 enrolled

Show 1 more trial

A Phase Ib Clinical Trial to Optimize Risk Benefit of REGN5678 (PSMAxCD28 Bispecific Antibody) Plus Cemiplimab (Anti-PD-1 Monoclonal Antibody) in Patients With Metastatic Castration-resistant Prostate Cancer

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06826768·60 enrolled

Basal Cell Carcinoma4 trials

Cemiplimab Plus Imiquimod and Laser Therapy As Neoadjuvant Treatment In Cutaneous Basal Cell Carcinoma

Recruiting·IInstituto Oncológico Dr Rosell·Phase 1/2·NCT07251413·18 enrolled

Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients

Recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT06981325·34 enrolled

Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery

Recruiting·TThomas Jefferson University·Phase 2·NCT05929664·70 enrolled

Show 1 more trial

PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

Completed· Regeneron logo

Regeneron·Phase 2·NCT03132636·138 enrolled

Solid Tumor4 trials

A First-in-Human Study of 89Zr-DFO-REGN5054 (Anti-CD8) Positron Emission Tomography in Patients With Solid Malignancies Treated With Cemiplimab

Active, not recruiting· Regeneron logo

Regeneron·Phase 1·NCT05259709·22 enrolled

A Phase 1, Multicenter, Open-Label, Dose Escalation, Dose Expansion and Dose Optimization Study of BHV-1530 as Monotherapy and in Combination With Other Anti-Cancer Agents in Adult Participants With Advanced or Metastatic Solid Tumors

Recruiting·BBiohaven Therapeutics Ltd.·Phase 1·NCT06874335·140 enrolled

Phase II Biomarker Study of BND-22 in Combination With Cemiplimab in Solid Tumors

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06651593·40 enrolled

Show 1 more trial

A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Active, not recruiting· Regeneron logo

Regeneron·Preclinical·NCT04626635·548 enrolled

Advanced Solid Tumors3 trials

LAG3 PET Imaging in Advanced Solid Tumors

Active, not recruiting·UUniversity Medical Center Groningen·Phase 1/2·NCT04706715·41 enrolled

An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors

Active, not recruiting·RRakuten Medical, Inc.·Phase 1/2·NCT04305795·23 enrolled

Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors

Recruiting·AAnkyra Therapeutics, Inc·Phase 1·NCT06171750·97 enrolled

Advanced Malignancies3 trials

Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

Completed· Regeneron logo

Regeneron·Phase 1·NCT02383212·398 enrolled

Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies

Active, not recruiting· Regeneron logo

Regeneron·Phase 1·NCT03233139·146 enrolled

Study of BDC-3042 as Single Agent and in Combination With Cemiplimab in Patients With Advanced Malignancies

Terminated·BBolt Biotherapeutics, Inc.·Phase 1·NCT06052852·17 enrolled

Ovarian Cancer3 trials

A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers

Recruiting· Regeneron logo

Regeneron·Phase 1·NCT06469281·90 enrolled

A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies

Recruiting· Regeneron logo

Regeneron·Preclinical·NCT04590326·612 enrolled

Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer

Recruiting· Regeneron logo

Regeneron·Phase 2·NCT06787612·297 enrolled

Renal Cell Carcinoma3 trials

Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma

Recruiting·UUniversity of Oklahoma·Phase 2·NCT07223541·72 enrolled

A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma

Active, not recruiting·SSillaJen, Inc.·Phase 1/2·NCT03294083·89 enrolled

A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06699602·10 enrolled

Colorectal Cancer3 trials

Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT06205836·44 enrolled

A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab and Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy

Recruiting·NNSABP Foundation Inc·Phase 2·NCT07058012·79 enrolled

Combining Capecitabine/Oxaliplatin Chemotherapy With Cemiplimab Alone or in Combination With Fianlimab or REGN7075 for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT07281768·66 enrolled

Glioblastoma3 trials

Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT07422363·30 enrolled

An Open-Label, Multi-Center Trial of INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With REGN2810 in Subjects With Newly-Diagnosed Glioblastoma (GBM)

Active, not recruiting· Inovio Pharmaceuticals logo

Inovio Pharmaceuticals·Preclinical·NCT03491683·52 enrolled

A Randomized Phase II Study of the Efficacy of Laser Interstitial Thermal Therapy (LiTT) Combined With Cemiplimab Versus Physician's Choice Chemotherapy in Recurrent Glioblastomas

Not yet recruiting·WWashington University School of Medicine·Phase 2·NCT07620548·99 enrolled

Lymphoma2 trials

Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma

Withdrawn· Regeneron logo

Regeneron·Phase 2·NCT04373083

A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.

Recruiting·OOncoNano Medicine, Inc.·Phase 1·NCT06022029·168 enrolled

Cervical Cancer2 trials

Study of Cemiplimab in Adults With Cervical Cancer

Completed· Regeneron logo

Regeneron·Phase 3·NCT03257267·608 enrolled

Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy

Completed· Regeneron logo

Regeneron·Phase 2·NCT04646005·113 enrolled

Maintenance Therapy2 trials

A PHASE II, RANDOMIZED TRIAL TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT VULVAR CANCER

Not yet recruiting·HHospital Israelita Albert Einstein·Phase 2·NCT07101848·42 enrolled

A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.

Recruiting·FFondazione Ricerca Traslazionale·Phase 2·NCT07264673·160 enrolled

Monoclonal2 trials

A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents

Recruiting·OOncoResponse, Inc.·Phase 1/2·NCT06090266·168 enrolled

A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents

Unknown status·OOncoResponse, Inc.·Phase 1/2·NCT05094804·172 enrolled

Breast Cancer2 trials

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Recruiting·QQuantumLeap Healthcare Collaborative·Phase 2·NCT01042379·5,000 enrolled

Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer

Recruiting·—·Phase 2·NCT06860815·11 enrolled

Lung Cancer2 trials

Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer

Recruiting·VVanderbilt-Ingram Cancer Center·Phase 1/2·NCT05501665·25 enrolled

A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer.

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05704634·56 enrolled

Glioma2 trials

REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma

Terminated· Regeneron logo

Regeneron·Phase 1/2·NCT03690869·57 enrolled

ASP8374 + Cemiplimab in Recurrent Glioma

Completed·—·Phase 1·NCT04826393·14 enrolled

Pancreatic Cancer2 trials

Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT04177810·25 enrolled

A Phase 2 Study With Combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), Chemokine (C-X-C) Motif Receptor 4 Inhibitor (BL-8040), and Immune Checkpoint Blockade (Cemiplimab) in METastatic Treatment naïve PANCreas Adenocarcinoma

Active, not recruiting·GGulam Manji·Phase 2·NCT04543071·118 enrolled

Lung Non-Small Cell Carcinoma2 trials

Phase II Single Arm Study of Neoadjuvant Dual Checkpoint Blockade With Programmed Death-ligand 1 (PD1) and Lymphocyte Activation Gene 3 (LAG-3) Inhibition in Resectable Non-Small Cell Lung Cancer (N-PLANC)

Recruiting·MMayo Clinic·Phase 2·NCT06918132·60 enrolled

Phase II Trial: Photoimmunotherapy and Anti-PD1 in Patients With Refractory Inoperable and Metastatic Non-Small Cell Lung Cancer

Withdrawn·RRoswell Park Cancer Institute·Phase 2·NCT06943664

Anaplastic Thyroid Cancer2 trials

A Multi-Center Single-Arm Phase 2 Trial Of Zanzalintinib In Combination With Cemiplimab In BRAF Wild-Type Anaplastic Thyroid Cancer: The ZEPHYR Trial

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07470489·12 enrolled

NEO-COMBAT XL: Neoadjuvant and Maintenance XL092 and Cemiplimab in BRAF V600E-wildtype Anaplastic Thyroid Cancer: a Phase 1B Study

Recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT06902376·12 enrolled

Colon Cancer2 trials

The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05961709·50 enrolled

NACho: A Study of Neo-Adjuvant Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer

Not yet recruiting·JJohn Strickler, M.D.·Phase 2·NCT07224022·24 enrolled

Head and Neck Cancer2 trials

A Pilot Study of Neoadjuvant Cemiplimab With Platinum-Doublet Chemotherapy, and Cetuximab in Patients With Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT04722523·40 enrolled

A Randomized Phase II Trial of Cemiplimab With or Without Fianlimab in Patients With Detectable Minimal-residual Disease After Definitive Treatment for Human Papillomavirus Positive HPV(+) Head and Neck Cancer.

Recruiting·UUniversity of Chicago·Phase 2·NCT07179315·68 enrolled

Metastatic NSCLC1 trial

A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC

Recruiting·MMaia Biotechnology·Phase 3·NCT06908304·300 enrolled

Biomarker1 trial

Hyperprogression in PD-L1 ≥ 50% NSCLC: a Biomarker Guided Phase 2 Trial

Not yet recruiting·UUniversità Vita-Salute San Raffaele·Phase 2·NCT07274384·74 enrolled

B-cell Malignancies1 trial

A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies

Active, not recruiting· Regeneron logo

Regeneron·Phase 1·NCT02651662·105 enrolled

Anti-PD-1 Antibody1 trial

Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in Participants With HIV-1 on Suppressive cART

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT03787095·5 enrolled

Advanced Cancers1 trial

Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

Completed· Regeneron logo

Regeneron·Phase 1·NCT03005782·333 enrolled

Treatment1 trial

Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT04988074·32 enrolled

Efficacy1 trial

Comparative Efficacy of Cemiplimab to Historical Standard of Care in France

Completed· Sanofi logo

Sanofi··NCT05302297·305 enrolled

Cancer1 trial

A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body

Recruiting· Regeneron logo

Regeneron·Phase 1/2·NCT06413680·240 enrolled

Immunotherapy1 trial

Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC

Recruiting·WWeill Medical College of Cornell University·Phase 2·NCT06623656·112 enrolled

Erectile Dysfunction1 trial

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06532149·80 enrolled

Antibody-Drug Conjugate1 trial

Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Adult Patients With Mesenchymal Epithelial Transition Factor (MET) Overexpressing Advanced Cancer

Terminated· Regeneron logo

Regeneron·Phase 1·NCT04982224·30 enrolled

Immune1 trial

Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01)

Completed·PPalleon Pharmaceuticals, Inc.·Phase 1/2·NCT05259696·69 enrolled

Patients With Solid Tumors1 trial

Expanded Access Use of Cemiplimab in Patients With Solid Tumors

Approved for marketing· Regeneron logo

Regeneron··NCT06132191

Acute Lymphoblastic Leukemia1 trial

Cemiplimab in AlloSCT/SOT Recipients With CSCC

Completed·—·Phase 1/2·NCT04339062·12 enrolled

Survivorship1 trial

CemiplimAb Survivorship Epidemiology

Completed· Regeneron logo

Regeneron··NCT03836105·287 enrolled

Metastatic Cancer1 trial

A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer

Terminated· Regeneron logo

Regeneron·Phase 2·NCT04916002·77 enrolled

Metastatic Melanoma1 trial

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Active, not recruiting· Regeneron logo

Regeneron·Phase 3·NCT05352672·1,546 enrolled

Oropharynx Squamous Cell Carcinoma1 trial

Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx Squamous Cell Carcinoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT05535023

Angiosarcoma1 trial

Cemiplimab for Secondary Angiosarcomas

Completed·RRadboud University Medical Center·Phase 2·NCT04873375·18 enrolled

Penile Cancer1 trial

A PHASE II, RANDOMIZED STUDY TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT PENILE CANCER

Not yet recruiting·HHospital Israelita Albert Einstein·Phase 2·NCT07101822·42 enrolled

Advanced1 trial

Anti-PD1-antibody and Pulsed HHI for Advanced BCC

Active, not recruiting·RReinhard Dummer·Phase 2·NCT04679480·20 enrolled

PD-1antibody1 trial

A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody

Active, not recruiting·HHotSpot Therapeutics, Inc·Phase 1/2·NCT05662397·77 enrolled

Cutaneous T-cell lymphoma1 trial

BIOmarker-guided Study to Evaluate the Efficacy and Safety of cemipLimab for advancEd Cutaneous T-cell Lymphoma

Withdrawn·AAHS Cancer Control Alberta·Phase 1/2·NCT05538988

Unresectable Solid Tumor1 trial

SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT04729725·3 enrolled

Neoadjuvant1 trial

Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for HNSCC

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT06855212·21 enrolled

Randomized1 trial

A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC

Unknown status·IISA Pharmaceuticals·Phase 2·NCT03669718·194 enrolled

PD-1 Inhibitors1 trial

A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors

Unknown status·SSilverback Therapeutics·Phase 1·NCT04460456·58 enrolled

Maintenance Treatment1 trial

Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer

Recruiting·AAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia·Phase 2·NCT07085572·31 enrolled

Advanced NSCLC1 trial

Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC

Active, not recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT05401786·54 enrolled

Acute Myeloid Leukemia1 trial

A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma

Recruiting·MMayo Clinic·Phase 1·NCT03017820·127 enrolled

Relapsed or Refractory1 trial

Study of Isatuximab and Cemiplimab in Relapsed or Refractory Natural Killer/T-cell Lymphoid Malignancy

Recruiting·WWon Seog Kim·Phase 2·NCT04763616·37 enrolled

Solid Tumor Malignancies1 trial

Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies

Terminated· Regeneron logo

Regeneron·Phase 1·NCT04465487·38 enrolled

Uveal Melanoma1 trial

Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT06121180·32 enrolled

ctDNA1 trial

PALACE: Cemiplimab Trial According to ctDNA Levels

Recruiting·FFundación GECP·Phase 2·NCT06917573·63 enrolled

Biliary Tract Cancer1 trial

Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)

Recruiting·—·Phase 2·NCT07433673·20 enrolled

Resectable NSCLC1 trial

Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients

Active, not recruiting· Regeneron logo

Regeneron·Phase 2·NCT03916627·65 enrolled

Refractory Tumor1 trial

5-Azacitidine Plus PD-1/PD-L1 Inhibitor With PD-1/PD-L1 Refractory Tumors

Not yet recruiting·MMohammed Milhem·Phase 1·NCT07404332·35 enrolled

HBV1 trial

Safety and Immunotherapeutic Activity of Cemiplimab in Participants With HBV on Suppressive Antiviral Therapy

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT04046107

Nasopharyngeal Carcinoma1 trial

A Pilot Randomized Trial of Induction Cemiplimab With or Without Fianlimab in De-escalated Chemoradiation for Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma

Not yet recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT07650266·60 enrolled

Bladder Cancer1 trial

A Phase 2, Randomized, Open-label Study of Gemcitabine/Cisplatin Plus Cemiplimab (REGN2810, Anti-PD-1) With or Without Fianlimab (REGN3767, Anti-LAG-3) for Organ Preservation in Patients With Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)

Terminated·CColumbia University·Phase 2·NCT06571708·1 enrolled

SMARCB1-Deficient Malignancies1 trial

Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06444880·15 enrolled

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression

Recruiting· Regeneron logo

Regeneron·Preclinical·NCT03972657·345 enrolled

Locally Advanced Basal Cell Carcinoma1 trial

Phase 2 Platform Trial of Combination Therapies for Participants With Locally Advanced Basal Cell Carcinoma: Master Protocol With Cemiplimab Monotherapy as Comparator Arm

Not yet recruiting· Regeneron logo

Regeneron·Phase 2·NCT07808515·135 enrolled

Metastatic NSCLC - Non-Small Cell Lung Cancer1 trial

Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50% A Multicentre Randomized Open-label Phase II Trial

Recruiting·SSwiss Cancer Institute·Phase 2·NCT07020065·156 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

A Phase 2 Window of Opportunity Trial of Neoadjuvant Agonistic Anti-CD40 Antibody CDX-1140 and Cemiplimab (REGN2810) in AJCC Stage III-IV Head and Neck Cancer Patients Prior to Surgery

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06980038·44 enrolled

Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v81 trial

A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients With Recurrent/Persistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07195734·180 enrolled

Head and Neck Squamous Cell Carcinoma (HNSCC)1 trial

Phase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Is Positive for PD-L1 Expression

Recruiting· Regeneron logo

Regeneron·Phase 2·NCT06769698·120 enrolled

Advanced Dedifferentiated Liposarcoma1 trial

Official Title A Randomized Phase 2 Trial With a Safety Lead-In to Evaluate Palbociclib Versus Palbociclib and Cemiplimab for the Treatment of Advanced Dedifferentiated Liposarcoma

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT05694871·77 enrolled

Invasive Breast Cancer1 trial

Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer (CemiHALT )

Active, not recruiting·MMedical College of Wisconsin·Phase 2·NCT04243616·36 enrolled

Kidney1 trial

A Phase 2 Study of Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma (CONTRAC-2)

Not yet recruiting·WWashington University School of Medicine·Phase 2·NCT07715734·22 enrolled

Plasma Cell Myeloma1 trial

International, Multi-center, Open-label, Treatment Extension Study in Patients With Multiple Myeloma Who Are Still Benefitting From Isatuximab-based Therapy Following Completion of a Phase 1, 2, or 3 Parental Study

Enrolling by invitation· Sanofi logo

Sanofi·Phase 2·NCT05669989·70 enrolled

Brain Tumor1 trial

A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin

Recruiting·IInSightec·Phase 3·NCT05317858·96 enrolled

Non-small Cell Lung Cancer (NSCLC)1 trial

A Phase 1b/2, Multicenter, Open-label Platform Study of Select Immunotherapy Combinations in Adult Participants With Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) With High PD-L1 Expression

Active, not recruiting·SServier Bio-Innovation LLC·Preclinical·NCT06162572·102 enrolled

Recurrent Lung Non-Small Cell Carcinoma1 trial

A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

Recruiting·SSWOG Cancer Research Network·Preclinical·NCT06616584·378 enrolled

Locally Advanced Cutaneous Squamous Cell Carcinoma1 trial

Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma

Not yet recruiting·MMelanoma and Skin Cancer Trials Limited·Phase 2·NCT06418724·27 enrolled

Advanced Melanoma1 trial

A Phase 2 Study of Fianlimab, Cemiplimab, and Ipilimumab in Anti-PD-1 Refractory Melanoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06594991·88 enrolled

Leiomyosarcoma1 trial

A Phase II Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma

Recruiting·GGabriel Tinoco·Phase 2·NCT06528769·16 enrolled

Recurrent Ovarian Cancer1 trial

A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers

Recruiting· Regeneron logo

Regeneron·Preclinical·NCT03564340·890 enrolled

Non Small Cell Lung Cancer (Squamous or Non Squamous)1 trial

Anti-PD1 Monotherapy in 1L Advanced NSCLC Patients With PD-L1 TPS > 50% and PTI=0

Recruiting·UUNICANCER·Phase 2·NCT07360743·275 enrolled

Malignant Skin Neoplasm1 trial

Short-Term Fasting Prior to Standard Checkpoint Blockade Using PD-1/PD-L1 Inhibition: A Pilot Safety and Feasibility Study

Active, not recruiting·UUniversity of Southern California·Phase 1·NCT04387084·10 enrolled

Adrenal Cortical Carcinoma1 trial

A Phase II Study of Cabozantinib in Combination With Cemiplimab (Cabo-Cemiplimab) Versus Cabozantinib Alone in Adolescents and Adults With Advanced Adrenocortical Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06900595·48 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

A Multicenter, Open-Label, Dose-Finding, Phase 2 Study Evaluating THIO Sequenced With Cemiplimab (LIBTAYO®) in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)

Active, not recruiting·MMaia Biotechnology·Phase 2·NCT05208944·227 enrolled

Cutaneous Squamous Cell Carcinoma (CSCC)1 trial

A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT06585410·369 enrolled

Hepatocellular Carcinoma1 trial

CLeAR: Pilot Study to Evaluate the Efficacy of Cemiplimab (PD-1 Inhibition) With or Without Fianlimab (LAG-3 Inhibition) After Y90 Radioembolization in Patients With Hepatocellular Carcinoma

Withdrawn·VVirginia Commonwealth University·Phase 1·NCT07365839

Metastatic Skin Squamous Cell Carcinoma1 trial

Pilot Study of Neoadjuvant/Adjuvant Cemiplimab for High Risk Cutaneous Squamous Cell Carcinoma

Active, not recruiting·EEmory University·Phase 1·NCT04428671·14 enrolled

Melanoma (Skin)1 trial

Fianlimab and Cemiplimab as Total Neoadjuvant Therapy (TNT) For Melanoma

Not yet recruiting·UUniversity of California, Irvine·Phase 2·NCT07527325·35 enrolled

Metastatic Colorectal Adenocarcinoma1 trial

A Phase 1 and Randomized Phase 2 Trial of Pidnarulex (CX-5461) and Cemiplimab (REGN2810) in Refractory Microsatellite Stable Colorectal Cancer

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT07147231·86 enrolled

Advanced Renal Cell Carcinoma (aRCC)1 trial

A Randomized Phase 2 Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)

Recruiting·BBrian Rini·Phase 2·NCT07188896·120 enrolled

Bladder Urothelial Carcinoma1 trial

Neoadjuvant STereotActic Body Radiotherapy and Cemiplimab With or Without Fianlimab for Cisplatin-Ineligible or Cisplatin-Declining Patients With Muscle-Invasive Bladder Cancer (NeoSTAR Bladder)

Withdrawn·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07414992

Solid Tumor, Adult1 trial

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNS-101 (Anti VISTA) as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Completed·SSensei Biotherapeutics, Inc.·Preclinical·NCT05864144·98 enrolled

Metastatic NUT Carcinoma1 trial

A Single Arm Open-Label Pilot Study to Investigate the Safety and Clinical Activity of Cemiplimab, A Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Incurable NUT Carcinoma (NC)

Recruiting·NNorthwestern University·Phase 2·NCT07050186·15 enrolled

Active, not recruiting· Regeneron logo

Regeneron·Phase 2·NCT06161441·195 enrolled

NSCLC1 trial

Adaptive Chemotherapy for Pd-l1 High REsEctablE NSCLC: A Chemo-PHREE Trial

Not yet recruiting·UUniversity of Maryland, Baltimore·Phase 2·NCT07746388·30 enrolled

Locally Recurrent Oral Cavity Squamous Cell Carcinoma1 trial

Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity and HPV-negative Oropharyngeal Squamous Cell Carcinoma

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06448026·17 enrolled

Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck1 trial

Phase II Study of REGN2810 Prior to Surgery in Patients With Stage II-IV Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03565783·44 enrolled

Lung Cancer (NSCLC)1 trial

Phase II Trial of Perioperative Cemiplimab in Patients With Resectable Non-small Cell Lung Cancer and PD-L1 ≥50%

Not yet recruiting·HHenry Ford Health System·Phase 2·NCT07450183·33 enrolled

Multiple Myeloma1 trial

Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Phase 1·NCT05137054·317 enrolled

Hormone-receptor-positive Breast Cancer1 trial

A Phase I Trial of Capecitabine in Combination With Cemiplimab in Patients With Hormone Receptor Positive Metastatic Breast Cancer

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT05064085·13 enrolled

Advanced Non-Small Cell Lung Cancer1 trial

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%

Active, not recruiting· Regeneron logo

Regeneron·Preclinical·NCT05785767·149 enrolled

Peripheral T-Cell Lymphoma1 trial

MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic/Dendritic Cell Neoplasms

Recruiting·MMayo Clinic·Phase 1·NCT06508463·21 enrolled

Metastatic Colorectal Cancer1 trial

A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06412198·31 enrolled

Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v81 trial

A Phase II Trial of the Efficacy and Safety of the Combination of Cemiplimab and Low-Dose Paclitaxel and Carboplatin in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Active, not recruiting·MMarcelo Bonomi·Phase 2·NCT04862650·46 enrolled

Carcinoma，Non-Small-Cell Lung1 trial

A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer

Completed· Regeneron logo

Regeneron·Phase 3·NCT03088540·712 enrolled

NSCLC Stage IV1 trial

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

Active, not recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT06219317·136 enrolled

Merkel Cell Carcinoma, Stage I1 trial

Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab - A Randomized, Double-blind, Placebo-controlled, Non-comparative Phase II Study

Recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT07387198·135 enrolled

Unspecified1 trial

A Phase 1/2, First in Human, Dose Escalation and Dose Expansion Study of BHV-1510 (Previously PBI-410) as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors

Recruiting·BBiohaven Therapeutics Ltd.·Preclinical·NCT06384807·500 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 28, 2018

LIBTAYO

NDA BLA761097

Jan 18, 2019

LIBTAYO

NDA BLA761097

Jun 25, 2020

LIBTAYO

NDA BLA761097

Nov 10, 2020

LIBTAYO

NDA BLA761097

Feb 9, 2021

LIBTAYO

NDA BLA761097

Feb 9, 2021

LIBTAYO

NDA BLA761097

Feb 22, 2021

LIBTAYO

NDA BLA761097

Nov 8, 2022

LIBTAYO

NDA BLA761097

Apr 28, 2023

LIBTAYO

NDA BLA761097

Apr 28, 2023

LIBTAYO

NDA BLA761097

Mar 6, 2024

LIBTAYO

NDA BLA761097

Apr 5, 2024

LIBTAYO

NDA BLA761097

Oct 8, 2025

LIBTAYO

NDA BLA761097

Oct 29, 2025

LIBTAYO

NDA BLA761097

Aug 31, 2026

LIBTAYO

NDA BLA761097

Sources

References

[1]
ClinicalTrials.gov — 183 trial records for Cemiplimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cemiplimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cemiplimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA761097). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Regeneron company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Programmed Cell Death Protein 1 Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Regeneron