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

Expanded Access Use of Cemiplimab in Patients With Solid Tumors

First Posted Date: 2023-11-15

Last Posted Date: 2024-11-08

Lead Sponsor: Regeneron Pharmaceuticals

Registration Number: NCT06132191

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

Phase 2

Recruiting

Conditions: Metastatic Uveal Melanoma

Interventions: Drug: ZIV-Aflibercept
Drug: Cemiplimab

First Posted Date: 2023-11-07

Last Posted Date: 2024-11-08

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 32

Registration Number: NCT06121180

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

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

Phase 1

Recruiting

Conditions: Cancer
Tumor, Solid
Metastatic Cancer
Malignant Neoplasm
Advanced Solid Tumor
Platinum-resistant Ovarian Cancer
Cutaneous Squamous Cell Carcinoma

Interventions: Drug: OR502
Drug: Cemiplimab

First Posted Date: 2023-10-19

Last Posted Date: 2023-11-02

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

and more 1 locations

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

Phase 1

Recruiting

Conditions: Triple Negative Breast Cancer
Colorectal Cancer
Clear Cell Renal Cell Carcinoma
Melanoma
Head and Neck Cancer
Ovarian Cancer
Non-small Cell Lung Cancer

Interventions: Drug: BDC-3042
Drug: Cemiplimab

First Posted Date: 2023-09-25

Last Posted Date: 2024-10-09

Lead Sponsor: Bolt Biotherapeutics, Inc.

Target Recruit Count: 147

Registration Number: NCT06052852

Locations: 🇺🇸
Stanford Cancer Center, Palo Alto, California, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
NEXT Oncology, San Antonio, Texas, United States

and more 2 locations

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.

Phase 1

Recruiting

Conditions: Lymphoma, Non-Hodgkin
Follicular Lymphoma
Bladder Cancer
Metastatic Cancer
Tumor Recurrence
Uveal Melanoma, Recurrent
Carcinoma in Situ
Skin Cancer
Tumor, Solid
Triple Negative Breast Cancer

Interventions: Drug: ONM-501
Drug: Cemiplimab

First Posted Date: 2023-09-01

Last Posted Date: 2024-11-27

Lead Sponsor: OncoNano Medicine, Inc.

Target Recruit Count: 168

Registration Number: NCT06022029

Locations: 🇦🇺
University of the Sunshine Coast Clinical Trials, Buderim, Queensland, Australia
🇦🇺
Southern Oncology Clinical Research Unit, Bedford Park, South Australia, Australia
🇺🇸
California Research Institute, Los Angeles, California, United States

and more 10 locations

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

Phase 2

Recruiting

Conditions: Colon Cancer

Interventions: Drug: Cemiplimab

First Posted Date: 2023-07-27

Last Posted Date: 2024-11-14

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 50

Registration Number: NCT05961709

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

Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

Phase 1

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: M1774
Drug: Cemiplimab

First Posted Date: 2023-05-31

Last Posted Date: 2024-08-15

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 180

Registration Number: NCT05882734

Locations: 🇧🇪
CHU de Liège - PARENT, Liege, Belgium
🇺🇸
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States
🇺🇸
UCLA Hematology and Oncology - Santa Monica, Santa Monica, California, United States

and more 51 locations

Deep sequencIng in Cutaneous Squamous CEll caRciNomas

Phase 2

Active, not recruiting

Conditions: Cutaneous Squamous Cell Carcinoma
Neoplasms
Cutaneous Squamous Cell Carcinoma of the Head and Neck
Non-melanoma Skin Cancer

Interventions: Drug: Cemiplimab

First Posted Date: 2023-05-26

Last Posted Date: 2024-11-21

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 11

Registration Number: NCT05878288

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Solid Tumor, Adult
Advanced Solid Tumor
Head and Neck Cancer
Breast Cancer
Colon Cancer
Pancreatic Cancer
Gastric Cancer
Esophageal Cancer
Prostate Cancer
Uterine Cancer

Interventions: Drug: SNS-101 (anti-VISTA)
Drug: Cemiplimab

First Posted Date: 2023-05-18

Last Posted Date: 2024-12-10

Lead Sponsor: Sensei Biotherapeutics, Inc.

Target Recruit Count: 169

Registration Number: NCT05864144

Locations: 🇺🇸
UCLA Hematology/Oncology, Los Angeles, California, United States
🇺🇸
University of Colorado Cancer Center - Anschutz Medical, Aurora, Colorado, United States
🇺🇸
Norton Healthcare, Louisville, Kentucky, United States

and more 8 locations

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

Phase 2

Recruiting

Conditions: Stage IV Lung Cancer AJCC v8
Metastatic Lung Non-Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Brain

Interventions: Procedure: Biospecimen Collection
Biological: Cemiplimab
Procedure: Computed Tomography
Procedure: Magnetic Resonance Elastography
Procedure: Positron Emission Tomography

First Posted Date: 2023-05-03

Last Posted Date: 2024-11-18

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 34

Registration Number: NCT05840770

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

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