MedPath

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

Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma

Phase 2
Completed
Conditions
Melanoma
Interventions
Drug: Ipilimumab
Biological: Vemurafenib
First Posted Date
2012-08-28
Last Posted Date
2018-07-24
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
70
Registration Number
NCT01673854
Locations
🇺🇸

University Hospitals Of Cleveland, Cleveland, Ohio, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Winship Cancer Institute, Atlanta, Georgia, United States

and more 11 locations

An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer

Phase 1
Completed
Conditions
Hepatocellular Carcinoma
Interventions
First Posted Date
2012-08-07
Last Posted Date
2024-11-19
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
659
Registration Number
NCT01658878
Locations
🇺🇸

Local Institution - 0002, Ann Arbor, Michigan, United States

🇺🇸

Local Institution - 0008, Los Angeles, California, United States

🇺🇸

Local Institution - 0048, Washington, District of Columbia, United States

and more 57 locations

PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma

Phase 1
Completed
Conditions
Advanced Melanoma
Metastatic Melanoma
Interventions
Biological: Nivolumab
Drug: Ipilimumab
First Posted Date
2012-06-18
Last Posted Date
2024-04-23
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
170
Registration Number
NCT01621490
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇳🇱

Local Institution - 0016, Amsterdam, Netherlands

🇺🇸

University Of Chicago, Chicago, Illinois, United States

and more 11 locations

A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma

Phase 1
Terminated
Conditions
Melanoma
Interventions
First Posted Date
2012-05-24
Last Posted Date
2019-03-26
Lead Sponsor
Incyte Corporation
Target Recruit Count
136
Registration Number
NCT01604889

Doxycycline, Temozolomide and Ipilimumab in Melanoma

Phase 1
Terminated
Conditions
Melanoma
Interventions
First Posted Date
2012-05-02
Last Posted Date
2020-09-02
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
12
Registration Number
NCT01590082
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Concurrent Ipilimumab and Stereotactic Ablative Radiation Therapy (SART) for Oligometastatic But Unresectable Melanoma

Phase 2
Conditions
Melanoma
Interventions
Drug: Ipilimumab
Radiation: Stereotactic Ablative Radiosurgery (SART)
First Posted Date
2012-03-29
Last Posted Date
2016-02-01
Lead Sponsor
Wolfram Samlowski
Target Recruit Count
50
Registration Number
NCT01565837
Locations
🇺🇸

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States

Study of Radiotherapy Administered in Combination With Ipilimumab in Patients With Unresectable Stage III or Stage IV Advanced Malignant Melanoma

Phase 1
Terminated
Conditions
Malignant Melanoma
Interventions
Drug: Ipilimumab
Radiation: Radiotherapy
First Posted Date
2012-03-19
Last Posted Date
2016-06-09
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Target Recruit Count
19
Registration Number
NCT01557114
Locations
🇫🇷

Institut Gustave Roussy, Villejuif, France

🇫🇷

Gustave Roussy Cancer Campus, Villejuif, Val de Marne, France

Ipilimumab and GMCSF Immunotherapy for Prostate Cancer

Phase 2
Withdrawn
Conditions
Prostate Cancer
Interventions
First Posted Date
2012-02-10
Last Posted Date
2015-10-05
Lead Sponsor
Lawrence Fong
Registration Number
NCT01530984
Locations
🇺🇸

University of California, San Francisco, California, United States

First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma

Phase 2
Completed
Conditions
Urothelial Carcinoma
Interventions
First Posted Date
2012-02-02
Last Posted Date
2022-07-11
Lead Sponsor
Hoosier Cancer Research Network
Target Recruit Count
36
Registration Number
NCT01524991
Locations
🇺🇸

IU Health Goshen Hospital, Goshen, Indiana, United States

🇺🇸

Tisch Cancer Institute at Mount Sinai Medical Center, New York, New York, United States

🇺🇸

City of Hope: Duarte, Duarte, California, United States

and more 5 locations

RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA

Phase 1
Completed
Conditions
Metastatic Melanoma
Interventions
Drug: Ipilimumab
Radiation: Stereotactic Body Radiation Therapy
First Posted Date
2011-12-23
Last Posted Date
2021-08-10
Lead Sponsor
Abramson Cancer Center at Penn Medicine
Target Recruit Count
22
Registration Number
NCT01497808
Locations
🇺🇸

Abramson Cancer Center of the Universirty of Pennsylvania, Philadelphia, Pennsylvania, United States

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