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.
Cemiplimab was first approved by the FDA on September 28, 2018, as the first FDA-approved treatment for advanced cutaneous squamous cell carcinoma (CSCC). It was later approved to be used in basal cell carcinoma and non-small non-small cell lung cancer. Cemiplimab was also approved by the European Commission on June 28, 2019. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended cemiplimab be granted marketing authorization for the treatment of cervical cancer.
- 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
A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- Interventions
- First Posted Date
- 2025-01-10
- Last Posted Date
- 2025-01-10
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 120
- Registration Number
- NCT06769698
A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma
- Conditions
- Advanced Melanoma
- Interventions
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2025-01-07
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 88
- Registration Number
- NCT06594991
- Locations
- 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸Stanford University (Data Collection Only), Stanford, California, United States
🇺🇸Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States
Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients with Advanced Leiomyosarcoma
- Conditions
- LeiomyosarcomaSarcoma
- Interventions
- Drug: all-trans retinoic acidDrug: CemiplimabProcedure: Computed TomographyProcedure: Magnetic resonance imagingProcedure: Biospecimen Collection
- First Posted Date
- 2024-07-30
- Last Posted Date
- 2025-01-09
- Lead Sponsor
- Gabriel Tinoco
- Target Recruit Count
- 16
- Registration Number
- NCT06528769
- Locations
- 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma
- Conditions
- Melanoma
- Interventions
- First Posted Date
- 2024-02-07
- Last Posted Date
- 2025-01-08
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 560
- Registration Number
- NCT06246916
- Locations
- 🇺🇸
The Melanoma And Skin Cancer Institute, Englewood, Colorado, United States
🇺🇸Cancer Specialist of North Florida, Jacksonville, Florida, United States
🇺🇸H. Lee Moffitt Cancer Center, Tampa, Florida, United States
A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
- Conditions
- CancerTumor, SolidMalignant NeoplasmMetastatic CancerAdvanced Solid TumorCutaneous MelanomaNon-small Cell Lung Cancer
- Interventions
- Drug: OR502Drug: Cemiplimab
- First Posted Date
- 2023-10-19
- Last Posted Date
- 2025-01-07
- Lead Sponsor
- OncoResponse, Inc.
- Target Recruit Count
- 168
- Registration Number
- NCT06090266
- Locations
- 🇺🇸
NEXT Dallas, Irving, Texas, United States
🇺🇸NEXT Oncology, San Antonio, Texas, United States
🇺🇸NEXT Virginia, Fairfax, Virginia, United States
A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer
- Conditions
- Cutaneous Squamous Cell CarcinomaSkin CancerSquamous Cell CarcinomaLocally Advanced Squamous Cell CarcinomaLocally Advanced Squamous Cell Carcinoma of the SkinLocally Advanced Cutaneous Squamous Cell CarcinomaLocally Advanced Skin Squamous Cell Carcinoma
- Interventions
- Drug: CemiplimabRadiation: Radiotherapy
- First Posted Date
- 2022-10-10
- Last Posted Date
- 2025-01-09
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 34
- Registration Number
- NCT05574101
- Locations
- 🇺🇸
University of Colorado (Data Collection Only), Aurora, Colorado, United States
🇺🇸Moffitt Cancer Center (Data Collection Only), Tampa, Florida, United States
🇺🇸Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States
Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- First Posted Date
- 2021-08-04
- Last Posted Date
- 2024-12-30
- Lead Sponsor
- University of Wisconsin, Madison
- Target Recruit Count
- 60
- Registration Number
- NCT04989946
- Locations
- 🇺🇸
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.