Cemiplimab

Generic Name: Cemiplimab

Brand Names: Libtayo

Drug Type: Biotech

Chemical Formula: -

CAS Number: 1801342-60-8

Unique Ingredient Identifier: 6QVL057INT

Background: Cemiplimab is a fully human monoclonal antibody that works against programmed death receptor-1 (PD-1), which is a negative regulator of T cell function. By blocking PD-1, cemiplimab works to enhance T cell-mediated antitumour responses.
...

Indication: Cemiplimab is indicated to treat:

Associated Conditions: Locally Advanced Basal Cell Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Locally Advanced Non-Small Cell Lung Cancer, Metastatic Cervical Cancer, Metastatic Non-Small Cell Lung Cancer, Metastatic cutaneous squamous cell carcinoma, Recurrent Cervical Cancer, Metastatic Basal cell carcinoma

Associated Therapies: First Line Chemotherapy

Clinical Trials

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

Phase 2

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: fianlimab
Drug: cemiplimab
Drug: Pemetrexed
Drug: Paclitaxel
Drug: Carboplatin
Drug: Placebo
Drug: Cisplatin

First Posted Date: 2023-04-05

Last Posted Date: 2024-11-14

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 950

Registration Number: NCT05800015

Locations: 🇺🇸
Crosson Cancer Institute, Fullerton, California, United States
🇺🇸
University of Illinois, Chicago, Illinois, United States
🇺🇸
Arizona Clinical Research Center, Tucson, Arizona, United States

and more 67 locations

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)

Phase 2

Recruiting

Conditions: Advanced Non-Small Cell Lung Cancer

Interventions: Drug: fianlimab
Drug: cemiplimab
Drug: Placebo

First Posted Date: 2023-03-27

Last Posted Date: 2024-11-14

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 850

Registration Number: NCT05785767

Locations: 🇺🇸
University of Illinois, Chicago, Illinois, United States
🇺🇸
Renovatio Clinical, El Paso, Texas, United States
🇹🇭
Prince Of Songkla Hospital, Prince Of Songkhla University, Hat-Yai, Songkhla, Thailand

and more 75 locations

Cemiplimab/Peg-Interferon-α in Advanced CSCC

Phase 1

Withdrawn

Conditions: Cutaneous Squamous Cell Carcinoma
Squamous Cell Carcinoma
Advanced Squamous Cell Carcinoma

Interventions: Drug: Cemiplimab-Rwlc
Drug: PEG-IFN alfa-2a

First Posted Date: 2023-02-15

Last Posted Date: 2023-08-09

Lead Sponsor: Baptist Health South Florida

Registration Number: NCT05729139

Locations: 🇺🇸
Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States

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.

Phase 1

Recruiting

Conditions: Lung Cancer

Interventions: Drug: Cemiplimab
Drug: Kevzara (Sarilumab)

First Posted Date: 2023-01-30

Last Posted Date: 2024-07-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 56

Registration Number: NCT05704634

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma

Phase 2

Active, not recruiting

Conditions: Metastatic Dedifferentiated Liposarcoma
Locally Advanced Dedifferentiated Liposarcoma
Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Advanced Dedifferentiated Liposarcoma
Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Unresectable Dedifferentiated Liposarcoma

Interventions: Drug: Palbociclib
Biological: Cemiplimab
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Biospecimen collection
Other: Questionnaire Administration

First Posted Date: 2023-01-23

Last Posted Date: 2024-10-26

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 77

Registration Number: NCT05694871

Locations: 🇺🇸
UH Seidman Cancer Center at UH Avon Health Center, Avon, Ohio, United States
🇺🇸
Creighton University Medical Center, Omaha, Nebraska, United States
🇺🇸
Fresno Cancer Center, Fresno, California, United States

and more 191 locations

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

Phase 1

Recruiting

Conditions: Solid Tumor, Adult
Refractory Cancer
Relapsed Cancer

Interventions: Drug: HST-1011
Biological: Cemiplimab

First Posted Date: 2022-12-22

Last Posted Date: 2024-12-19

Lead Sponsor: HotSpot Therapeutics, Inc

Target Recruit Count: 203

Registration Number: NCT05662397

Locations: 🇪🇸
Clínica Universidad de Navarra (Madrid), Madrid, Spain
🇪🇸
NEXT Oncology Hospital Universitario Quirónsalud Madrid, Madrid, Spain
🇪🇸
Clínica Universidad de Navarra (Pamplona), Pamplona, Spain

and more 11 locations

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

Phase 3

Recruiting

Conditions: Melanoma

Interventions: Drug: Fianlimab
Drug: Pembrolizumab
Drug: Cemiplimab
Drug: Placebo

First Posted Date: 2022-11-08

Last Posted Date: 2024-11-19

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 1530

Registration Number: NCT05608291

Locations: 🇺🇸
UCSF Medical Center, Investigational Pharmacy, San Francisco, California, United States
🇺🇸
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
🇺🇸
Cancer Center IDS UVA Cancer Center IDS Pharmacy, Charlottesville, Virginia, United States

and more 204 locations

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

Phase 2

Recruiting

Conditions: Cutaneous Squamous Cell Carcinoma
Skin Cancer
Squamous Cell Carcinoma
Locally Advanced Squamous Cell Carcinoma
Locally Advanced Squamous Cell Carcinoma of the Skin
Locally Advanced Cutaneous Squamous Cell Carcinoma
Locally Advanced Skin Squamous Cell Carcinoma

Interventions: Drug: Cemiplimab
Radiation: Radiotherapy

First Posted Date: 2022-10-10

Last Posted Date: 2024-11-04

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 34

Registration Number: NCT05574101

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States
🇺🇸
Cleveland Clinic (Data Collection Only), Cleveland, Ohio, United States
🇺🇸
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities), Commack, New York, United States

and more 10 locations

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)

Phase 2

Recruiting

Conditions: Advanced Non-Small Cell Lung Cancer

Interventions: Drug: BNT116
Drug: Cemiplimab

First Posted Date: 2022-09-28

Last Posted Date: 2024-11-05

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 100

Registration Number: NCT05557591

Locations: 🇺🇸
The Oncology Institute of Hope and Innovation, Los Angeles, California, United States
🇺🇸
University of California Irvine, Orange, California, United States
🇺🇸
Weill Cornell Medical College, New York, New York, United States

and more 52 locations

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

Phase 1

Not yet recruiting

Conditions: Mycosis Fungoides

Interventions: Drug: Cemiplimab

First Posted Date: 2022-09-14

Last Posted Date: 2024-06-14

Lead Sponsor: AHS Cancer Control Alberta

Target Recruit Count: 16

Registration Number: NCT05538988

Locations: 🇨🇦
Cross Cancer Institute, Edmonton, Alberta, Canada

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