Ipilimumab

Generic Name: Ipilimumab

Brand Names: Yervoy

Drug Type: Biotech

Chemical Formula: -

CAS Number: 477202-00-9

Unique Ingredient Identifier: 6T8C155666

Background: Ipilimumab is a fully humanized IgG1 monoclonal antibody that blocks cytotoxic T lymphocyte antigen-4 (CTLA-4). Blocking CTLA-4 removes an inhibitory signal from reducing the activity of T lymphocytes. Ipilimumab was developed by Bristol-Myers Squibb and Medarex.

Ipilimumab was granted FDA approval on 25 March 2011.

Indication: Ipilimumab is indicated in the following cancerous conditions:

Melanoma

Renal Cell Carcinoma (RCC)

Colorectal Cancer

Hepatocellular Carcinoma

Non-Small Cell Lung Cancer (NSCLC)

Malignant Pleural Mesothelioma

Esophageal Cancer

- Treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first line treatment in combination with nivolumab

Associated Conditions: Cutaneous Melanoma, Hepatocellular Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Microsatellite Instability High Metastatic Colorectal Cancer (CRC), Mismatch Repair-deficient (dMMR) Metastatic Colorectal Cancer (CRC), Recurrent Non-small Cell Lung Cancer, Unresectable Melanoma, Poor or intermediate risk Advanced Renal Cell Carcinoma (aRCC), Unresectable Malignant Pleural Mesothelioma (MPM), Unresectable, advanced Esophageal Squamous Cell Carcinoma (ESCC)

Associated Therapies: First Line Chemotherapy

Clinical Trials

Intratumoral CAVATAK (CVA21) and Ipilimumab in Patients With Advanced Melanoma (VLA-013 MITCI)

Phase 1

Completed

Conditions: Melanoma

Interventions: Biological: CAVATAK
Drug: Ipilimumab

First Posted Date: 2014-12-04

Last Posted Date: 2023-01-17

Lead Sponsor: Viralytics

Target Recruit Count: 50

Registration Number: NCT02307149

Locations: 🇺🇸
The Angeles Clinic & Research Institute, Los Angeles, California, United States
🇺🇸
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
🇺🇸
Advocate Health, SC, Park Ridge, Illinois, United States

and more 8 locations

Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive

Phase 2

Completed

Conditions: Prostate Cancer

Interventions: Drug: Ipilimumab

First Posted Date: 2014-10-31

Last Posted Date: 2019-08-28

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 82

Registration Number: NCT02279862

Locations: 🇮🇹
Istituto Nazionale Tumori Fondazione Pascale, Napoli, Italy
🇩🇪
Universitaetsklinikum Aachen, Aachen, Germany
🇺🇸
Nebraska Cancer Specialists, Omaha, Nebraska, United States

and more 19 locations

Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma

Phase 1

Completed

Conditions: Malignant Melanoma

Interventions: Drug: Ipilimumab
Biological: UV1 vaccine
Biological: GM-CSF

First Posted Date: 2014-10-27

Last Posted Date: 2024-12-16

Lead Sponsor: Ultimovacs ASA

Target Recruit Count: 12

Registration Number: NCT02275416

Locations: 🇳🇴
Oslo University Hospital, Radiumhospitalet, Oslo, Norway

Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC

Phase 2

Active, not recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Nivolumab
Drug: Carboplatin
Drug: Ipilimumab
Drug: Paclitaxel

First Posted Date: 2014-10-08

Last Posted Date: 2024-08-27

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 39

Registration Number: NCT02259621

Locations: 🇨🇦
Johnathan Spicer, Montréal, Quebec, Canada
🇺🇸
Johns Hopkins at Bayview Medical Center, Baltimore, Maryland, United States
🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

and more 2 locations

Ipilimumab and Stereotactic Body Radiation Therapy (SBRT) in Advanced Solid Tumors

Phase 1

Completed

Conditions: Lung Cancer
Liver Cancer

Interventions: Drug: Ipilimumab
Radiation: Stereotactic Body Radiation Therapy (SBRT)

First Posted Date: 2014-09-15

Last Posted Date: 2020-11-30

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 143

Registration Number: NCT02239900

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey

Completed

Conditions: Advanced Melanoma

Interventions: Drug: Ipilimumab

First Posted Date: 2014-08-25

Last Posted Date: 2015-12-21

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 158

Registration Number: NCT02224768

Locations: 🇬🇧
Local Institution, St. Ives, Cambridgeshire, United Kingdom
🇺🇸
Bristol-Myers Squibb, Princeton, New Jersey, United States

Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma

Phase 3

Active, not recruiting

Conditions: Clinical Stage III Cutaneous Melanoma AJCC v8
Recurrent Melanoma
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Melanoma
Unresectable Melanoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Dabrafenib Mesylate
Procedure: Echocardiography
Biological: Ipilimumab
Procedure: Multigated Acquisition Scan
Biological: Nivolumab
Drug: Trametinib Dimethyl Sulfoxide
Other: Quality-of-Life Assessment

First Posted Date: 2014-08-25

Last Posted Date: 2024-12-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 300

Registration Number: NCT02224781

Locations: 🇺🇸
Kaiser Permanente-Fontana, Fontana, California, United States
🇺🇸
Palo Alto Medical Foundation-Fremont, Fremont, California, United States
🇺🇸
Kaiser Permanente-Fresno, Fresno, California, United States

and more 838 locations

Study of Combined Ionizing Radiation and Ipilimumab in Metastatic Non-small Cell Lung Cancer (NSCLC)

Phase 1

Completed

Conditions: Non-small Cell Lung Cancer (NSCLC)

Interventions: Drug: Ipilimumab
Radiation: Radiotherapy (IMRT or 3-D CRT)

First Posted Date: 2014-08-20

Last Posted Date: 2020-05-11

Lead Sponsor: NYU Langone Health

Target Recruit Count: 39

Registration Number: NCT02221739

Locations: 🇺🇸
NYU Clinical Cancer Center, New York, New York, United States
🇺🇸
NYU Langone Medical Center, Tisch Hospital, New York, New York, United States