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
...

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

Study of Neoadjuvant Ipilimumab in Patients With Urothelial Carcinoma Undergoing Surgical Resection

Phase 1

Completed

Conditions: Urothelial Carcinoma

Interventions: Drug: Ipilimumab

First Posted Date: 2006-08-10

Last Posted Date: 2016-09-30

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 12

Registration Number: NCT00362713

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

Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

Phase 3

Completed

Conditions: Melanoma

Interventions: Drug: Placebo
Drug: Ipilimumab
Drug: Dacarbazine

First Posted Date: 2006-05-10

Last Posted Date: 2014-11-02

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 681

Registration Number: NCT00324155

Locations: 🇺🇸
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
🇺🇸
Providence Portland Medical Center, Portland, Oregon, United States
🇺🇸
St Joseph Oncology Inc, Saint Joseph, Missouri, United States

and more 30 locations

Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Phase 2

Completed

Conditions: Melanoma

Interventions: Drug: ipilimumab (MDX-010, BMS-734016)
Drug: Ipilimumab

First Posted Date: 2006-02-10

Last Posted Date: 2010-03-02

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 210

Registration Number: NCT00289640

Locations: 🇺🇸
Center For Oncology Research & Treatment, P.A., Dallas, Texas, United States
🇺🇸
Oncology Specialists, Sc, Park Ridge, Illinois, United States
🇺🇸
St Joseph Oncology Inc, St Joseph, Missouri, United States

and more 23 locations

Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)

Phase 1

Completed

Conditions: Unresectable Stage III or IV Malignant Melanoma

Interventions: Drug: Ipilimumab

First Posted Date: 2005-12-05

Last Posted Date: 2016-09-29

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 80

Registration Number: NCT00261365

Locations: 🇺🇸
Comprehensive Cancer Center, Palm Springs, California, United States
🇺🇸
The Angeles Clinic And Research Institution, Santa Monica, California, United States
🇸🇪
Local Institution, Stockholm, Sweden

and more 1 locations

Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer

Phase 2

Completed

Conditions: Stage III Prostate Cancer
Prostate Adenocarcinoma
Stage IV Prostate Cancer
Prostate Carcinoma
Recurrent Prostate Carcinoma

Interventions: Drug: Bicalutamide
Drug: Flutamide
Drug: Goserelin Acetate
Drug: Leuprolide Acetate
Drug: Ipilimumab
Other: Pharmacological Study

First Posted Date: 2005-09-15

Last Posted Date: 2017-05-15

Lead Sponsor: Mayo Clinic

Target Recruit Count: 112

Registration Number: NCT00170157

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

Phase 2

Completed

Conditions: Melanoma

Interventions: Drug: Ipilimumab

First Posted Date: 2005-09-13

Last Posted Date: 2016-07-27

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 248

Registration Number: NCT00162123

Locations: 🇺🇸
The Angeles Clinic & Research Inst., Los Angeles, California, United States
🇺🇸
University Of Chicago, Chicago, Illinois, United States
🇺🇸
Indiana Oncology Hematology Consultants, Indianapolis, Indiana, United States

and more 16 locations

Ipilimumab After Allogeneic Stem Cell Transplant in Treating Patients With Persistent or Progressive Cancer

Phase 1

Completed

Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Childhood Myelodysplastic Syndromes
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Disseminated Neuroblastoma
Malignant Neoplasm

Interventions: Drug: ipilimumab
Drug: therapeutic allogeneic lymphocytes

First Posted Date: 2003-05-07

Last Posted Date: 2013-03-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 21

Registration Number: NCT00060372

Locations: 🇺🇸
Scripps Clinic - La Jolla, La Jolla, California, United States
🇺🇸
University of California San Diego, La Jolla, California, United States
🇺🇸
Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States

and more 2 locations

Drug Development Updates

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