MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma

NCT ID: NCT00094653

Last Updated: 2011-07-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1783 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.

Detailed Description

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Melanoma accounts for approximately 5% of all skin cancers in the United States, but it accounts for about 75% of all skin cancer deaths. In 2004, the expected prevalence of melanoma is 627,252, with about 119,178 of these cases being Stage III or IV (metastatic melanoma). First line treatments for metastatic melanoma, usually IL-2, dacarbazine and/or temozolomide, are associated with significant toxicities. MDX-010 (anti-CTLA4) antibodies are designed to keep the immune system running by blocking CTLA-4 from down-regulating T cell activation. MDX-1379 is made up of two peptides that are pieces of a bigger melanoma protein (gp100). These peptides bind to HLA-A2 which is then recognized by T cells.

Conditions

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Melanoma Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Melanoma Peptide Vaccine (MDX-1379) (gp100) + Placebo

Group Type ACTIVE_COMPARATOR

MDX-1379 (gp100) Melanoma Peptide Vaccine

Intervention Type BIOLOGICAL

2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.

2

MDX-010 (ipilimumab) + MDX-1379 (gp100) (Melanoma Peptide Vaccine)

Group Type EXPERIMENTAL

MDX-010 (anti-CTLA4) monoclonal antibody

Intervention Type DRUG

3mg/kg (intravenous \[iv\] infusion over 90 minutes), every 3 weeks for 4 doses

MDX-1379 (gp100) Melanoma Peptide Vaccine

Intervention Type BIOLOGICAL

2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.

3

MDX-010 (ipilimumab) + Placebo

Group Type ACTIVE_COMPARATOR

MDX-010 (anti-CTLA4) monoclonal antibody

Intervention Type DRUG

3mg/kg (intravenous \[iv\] infusion over 90 minutes), every 3 weeks for 4 doses

Interventions

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MDX-010 (anti-CTLA4) monoclonal antibody

3mg/kg (intravenous \[iv\] infusion over 90 minutes), every 3 weeks for 4 doses

Intervention Type DRUG

MDX-1379 (gp100) Melanoma Peptide Vaccine

2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.

Intervention Type BIOLOGICAL

Other Intervention Names

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ipilimumab melanoma peptide vaccine

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with malignant melanoma
* Measurable unresectable Stage III or IV melanoma
* HLA-A\*0201 positive
* Previous treatment with \& failure/relapse/inability to tolerate IL-2, dacarbazine and/or temozolomide
* At least 4 weeks since prior treatment
* Negative pregnancy
* Life expectancy greater than 4 months
* Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
* Required lab values
* Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) negative

Exclusion Criteria

* Prior malignancies which the patient has not been disease free for over 5 years, except treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer
* Ocular melanoma
* Active, untreated central nervous system (CNS) metastasis
* Prior treatment with MDX-010 (anti-CTLA4) antibody
* Prior treatment with any cancer therapeutic vaccine
* Active autoimmune disease or history of autoimmune disease
* Pregnancy or nursing
* Hypersensitivity to Incomplete Freund's Adjuvant (IFA) (Montanide ISA-51)
* Underlying medical conditions deemed hazardous if treated with study drug
* Concomitant therapy with anti-melanoma drugs, chemotherapies, other investigational therapies, chronic use of systemic corticosteroids
* Unable to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Arizona Cancer Center

Tucson, Arizona, United States

Site Status

University Medical Center

Tucson, Arizona, United States

Site Status

City of Hope National Medical Center

Duarte, California, United States

Site Status

San Diego Cancer Center

Encinitas, California, United States

Site Status

La Jolla Hematology and Oncology Medical Group

La Jolla, California, United States

Site Status

Scripps Cancer Center

La Jolla, California, United States

Site Status

Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

Pacific Shores Medical Group

Long Beach, California, United States

Site Status

Cancer Institute Medical Group, Inc

Los Angeles, California, United States

Site Status

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Site Status

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

North County Oncology Medical Clinical, Inc.

Oceanside, California, United States

Site Status

City of Hope Medical Group

Pasadena, California, United States

Site Status

University of California, San Diego

San Diego, California, United States

Site Status

St. Mary's Medical Center - Northern California Melanoma Center

San Francisco, California, United States

Site Status

Cancer Institute Medical Group, Inc

Santa Monica, California, United States

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San Diego Cancer Center

Vista, California, United States

Site Status

Anschutz Cancer Pavilion

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Site Status

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Boulder, Colorado, United States

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Rocky Mountain Cancer Centers

Colorado Springs, Colorado, United States

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Rocky Mountain Cancer Centers

Denver, Colorado, United States

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University of Colorado Hospital

Denver, Colorado, United States

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Rocky Mountain Cancer Centers

Lakewood, Colorado, United States

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Rocky Mountain Cancer Centers

Littleton, Colorado, United States

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Rocky Mountain Cancer Centers

Lone Tree, Colorado, United States

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Rocky Mountain Cancer Centers

Longmont, Colorado, United States

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Yale University School of Medicine - Oncology Outpatient Clinic

New Haven, Connecticut, United States

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Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

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Memorial Regional Cancer Center

Hollywood, Florida, United States

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Shands Jacksonville

Jacksonville, Florida, United States

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University of Florida/Jacksonville Faculty Clinic

Jacksonville, Florida, United States

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Jackson Memorial Hospital & Clinics

Miami, Florida, United States

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University of Miami Hospital & Clinics

Miami, Florida, United States

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Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

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Mount Sinai Medical Center

Miami Beach, Florida, United States

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M.D. Anderson Cancer Center Orlando

Orlando, Florida, United States

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Palm Beach Cancer Institute

Palm Beach Gardens, Florida, United States

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H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

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Palm Beach Cancer Institute

Wellington, Florida, United States

Site Status

Palm Beach Cancer Institute

West Palm Beach, Florida, United States

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Emory University Hospital-Winship Cancer Institute

Atlanta, Georgia, United States

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Cancer Care Specialists of Central IL

Decatur, Illinois, United States

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Decatur Memorial Hospital

Decatur, Illinois, United States

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Cancer Care Specialists of Central IL

Effingham, Illinois, United States

Site Status

Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.

Maywood, Illinois, United States

Site Status

Center for Cancer Care at Goshen Health System

Goshen, Indiana, United States

Site Status

Indiana Oncology Hematology Consultants North

Indianapolis, Indiana, United States

Site Status

American Health Network of IN, LLC

Indianapolis, Indiana, United States

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Indiana Oncology Hematology South

Indianapolis, Indiana, United States

Site Status

Indiana Oncology Hematology Consutants of Noblesville

Noblesville, Indiana, United States

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Central Baptist Hospital

Lexington, Kentucky, United States

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James Graham Brown Cancer Center

Louisville, Kentucky, United States

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Norton Hospital

Louisville, Kentucky, United States

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University of Louisville Hospital

Louisville, Kentucky, United States

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

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Franklin Square Hospital Center

Baltimore, Maryland, United States

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lutherville, Maryland, United States

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Beth Isreal Dec Medical Center

Boston, Massachusetts, United States

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Brigham and Womens Hospital

Boston, Massachusetts, United States

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

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Henry Ford Medical Center

Dearborn, Michigan, United States

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Henry Ford Hospital

Detroit, Michigan, United States

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Henry Ford Medical Center- West Bloomfield

West Bloomfield, Michigan, United States

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Humphrey Cancer Center

Coon Rapids, Minnesota, United States

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Humphrey Cancer Center

Fridley, Minnesota, United States

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Hubert H Humphrey Cancer Center

Robbinsdale, Minnesota, United States

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Family Cancer Center

Olive Branch, Mississippi, United States

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Ellis Fischel Cancer Center

Columbia, Missouri, United States

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St. Joseph Oncology, Inc

Saint Joseph, Missouri, United States

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Barnes Jewish Hospital

St Louis, Missouri, United States

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Washington Unv. School of Med./ Siteman Cancer Center

St Louis, Missouri, United States

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Hackensack University Medical Center

Hackensack, New Jersey, United States

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The Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

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Hematology-Oncology Associates of Northern NJ, PA

Morristown, New Jersey, United States

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Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

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The Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

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Overlook Oncology Center

Summit, New Jersey, United States

Site Status

New Mexico Oncology Hematology Consultants, Ltd.

Albuquerque, New Mexico, United States

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Hematology-Oncology Associates of CNY

East Syracuse, New York, United States

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Columbia University Medical Center, Irving Center for Clinical Research

New York, New York, United States

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

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The Christ Hospital Cancer Center

Cincinnati, Ohio, United States

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The Cleveland Clinic Foundation

Cleveland, Ohio, United States

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Providence Portland Medical Center

Portland, Oregon, United States

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The Oregon Clinical

Portland, Oregon, United States

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Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

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Thomas Jefferson University Hosptital

Philadelphia, Pennsylvania, United States

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

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Hillman Cancer Research Pavilion

Pittsburgh, Pennsylvania, United States

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Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

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University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

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Cancer Centers of the Carolinas

Easley, South Carolina, United States

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Cancer Centers of the Carolinas

Greenville, South Carolina, United States

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Cancer Centers of the Carolinas

Seneca, South Carolina, United States

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Cancer Centers of the Carolinas

Spartanburg, South Carolina, United States

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Family Cancer Center

Bartlett, Tennessee, United States

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Family Cancer Center

Collierville, Tennessee, United States

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Family Cancer Center

Memphis, Tennessee, United States

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The West Clinic

Memphis, Tennessee, United States

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

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Arlington Cancer Center

Arlington, Texas, United States

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Center for Oncology Research and Treatment

Dallas, Texas, United States

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Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

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Center for Oncology Research and Treatment

Richardson, Texas, United States

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Huntsman Cancer Institute

Salt Lake City, Utah, United States

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Huntsman Cancer Institute

Salt Lake City, Utah, United States

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Fletcher Allen Health Care

Burlington, Vermont, United States

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Hospital Municipal de Oncoligia Maria Curie

Ciudad de Buenos Aires, Buenos Aires, Argentina

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Instituto Medico Platense

La Plata, Buenos Aires, Argentina

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ISIS Clinica Especializada

Santa Fe, Santa Fe Province, Argentina

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Hospital Militar Central

Buenos Aires, , Argentina

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Instituto Medico Especializado Alexander Fleming

Buenos Aires, , Argentina

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Hospital Britanico de Buenos Aires

Ciudad de Buenos Aires, , Argentina

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Hospital Municipal de Oncologia Maria Curie

Ciudad de Buenos Aires, , Argentina

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Hospital General de Agudos Carlos G. Durand

Ciudad de Buenos Aires, , Argentina

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Instituto de Oncologia Angel H. Roffo

Ciudad de Buenos Aires, , Argentina

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Hospital Militar Central

Ciudad de Buenos Aires, , Argentina

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Instituto Alexander Fleming

Ciudad de Buenos Aires, , Argentina

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Hospital Privado de Cordoba S.A.

Córdoba, , Argentina

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Hospital Privado Centro Medico de Cordoba S.A.

Córdoba, , Argentina

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ISIS Clinica Especializada

Santa Fe, , Argentina

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Institut Jules Bordet

Brussels, , Belgium

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Erasme Hospital, Free Universtiy of Brussels

Brussels, , Belgium

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Erasme Hospital

Brussels, , Belgium

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U.Z. Gent

Ghent, , Belgium

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Universitair Ziekenhuis Gasthuisberg

Leuven, , Belgium

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Cliniques Universitaires UCL de Mont-Godinne

Yvoir, , Belgium

Site Status

Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias

Goiânia, Goiás, Brazil

Site Status

Pro Onco Centro Tratamento Oncologico

Londrina, Paraná, Brazil

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Hospital Sao Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

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Fundacao Pio XII - Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

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Fundacoa Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

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Santo Andre Diagnosticos aTratamentos

Santo André, São Paulo, Brazil

Site Status

Sociedade Beneficante de Sennores - Hospital Sino Libante

São Paulo, São Paulo, Brazil

Site Status

Hospital de Cancer de Barretos - Fundacao Pio XII

Barretos - SP, , Brazil

Site Status

Biocor - Hosp. de Doencas Cardiovasculares Ltda.

Belo Horizonte - MG, , Brazil

Site Status

Hospital Araujo Jorge

Goiania - GO, , Brazil

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Pro Onco Centro Tratemento Oncologico

Londrina - PR, , Brazil

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Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD

Porto Alegre, , Brazil

Site Status

Fund. SOAD / HC de Porto Alegre

Porto Alegre - RS, , Brazil

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Hospital Sao Lucas - PUCRS

Porto Alegre - RS, , Brazil

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Santo Andre Diagnosticos e Tratamentos Ltda.

Santo Andre-SP, , Brazil

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HC-FMUSP

Sao Paulo - SP, , Brazil

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Hospital Sirio Labanes

Sao Paulo-SP, , Brazil

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Tom Baker Cancer Centre

Calgary, Alberta, Canada

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Cross Cancer Institute

Edmonton, Alberta, Canada

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CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

Cancer Centre of Southeastern Ontario at KGH

Kingston, Ontario, Canada

Site Status

London Regional Cancer Program

London, Ontario, Canada

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The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Instituto Nacional del Cancer

Independencia, Santiago Metropolitan, Chile

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Clinica Davila

Recoleta, Santiago Metropolitan, Chile

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Fundacion Arturo Lopez Perez

Santiago, Santiago Metropolitan, Chile

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Hospital Barros Luco

Santiago, Santiago Metropolitan, Chile

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Clinica Renaca

Reñaca, Vina Del Mar, Chile

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Centre Oscar Lambret

Lille, , France

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Centre Leon Berard

Lyon, , France

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Hopital Sainte-Marguerite

Marseille, , France

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Hopital Saint-Eloi

Montpellier, , France

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Hotel Dieu

Nantes, , France

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Centre Antoine Lacassagne

Nice, , France

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Hopital Saint-Louis

Paris, , France

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Centre Eugene Marquis

Rennes, , France

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Centre-Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, , France

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Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

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Institut Gustave Roussy (IGR)

Villejuif, , France

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Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie

Hufelandstr. 55, Hesse, Germany

Site Status

Klinikum Augsburg

Augsburg, , Germany

Site Status

Charite Universitaets medizin Berlin

Berlin, , Germany

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Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin

Berlin, , Germany

Site Status

Universitaetsklinikum Dusseldorf

Düsseldorf, , Germany

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Universitaetsklinikum Erlangen

Erlangen, , Germany

Site Status

Universitaetsklinikum Essen

Essen, , Germany

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Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Klinikum der Friedrich-Schiller-Universitaet Jena

Jena, , Germany

Site Status

Klinikum Mannheim gGmbH

Mannheim, , Germany

Site Status

University of Mannheim

Mannheim, , Germany

Site Status

Klinikum Rechts der Isar / TU Muenchen

München, , Germany

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Universitaetsklinikum Tuebingen

Tübingen, , Germany

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Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status

National Institute of Oncology

Budapest, , Hungary

Site Status

University of Debrecen, Medical and Health Sciences Center

Debrecen, , Hungary

Site Status

Semmelweis Hospital

Miskolc, , Hungary

Site Status

University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center

Szeged, , Hungary

Site Status

Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, , Netherlands

Site Status

Vrije Universiteit Medisch Centrum (VUMC)

Amsterdam, , Netherlands

Site Status

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Site Status

Mary Potter Oncology Centre

Groenkloof, , South Africa

Site Status

GVI Oncology

Panorama, , South Africa

Site Status

Mary Potter Oncology Centre

Pretoria, , South Africa

Site Status

Sandton Onocology Medical Research

Sandton, , South Africa

Site Status

Centre Hospitalier Universitaire Vaudois - CHUV

Lausanne, Rue Du Bugnon 46, Switzerland

Site Status

Centre Hospitalier Universitaire Vaudois - CHUV

Lausanne, , Switzerland

Site Status

Dermatologische Klinik Universitatsspital Zurich

Zurich, , Switzerland

Site Status

St. Luke's Cancer Center, The Royal Surrey County Hospital

Guildford, Surry, United Kingdom

Site Status

Velindre Hospital

Cardiff, , United Kingdom

Site Status

Ninewells Hospital

Dundee, , United Kingdom

Site Status

Christie Hospital

Manchester, , United Kingdom

Site Status

Nottingham City Hospital

Nottingham, , United Kingdom

Site Status

Churchill Hospital

Oxford, , United Kingdom

Site Status

Poole Hospital

Poole, , United Kingdom

Site Status

Weston Park Hospital

Sheffield, , United Kingdom

Site Status

Southampton General

Southampton, , United Kingdom

Site Status

Countries

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United States Argentina Belgium Brazil Canada Chile France Germany Hungary Netherlands South Africa Switzerland United Kingdom

References

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Hatswell AJ, Pennington B, Pericleous L, Rowen D, Lebmeier M, Lee D. Patient-reported utilities in advanced or metastatic melanoma, including analysis of utilities by time to death. Health Qual Life Outcomes. 2014 Sep 10;12:140. doi: 10.1186/s12955-014-0140-1.

Reference Type DERIVED
PMID: 25214238 (View on PubMed)

Larkin J, Hatswell AJ, Nathan P, Lebmeier M, Lee D. The Predicted Impact of Ipilimumab Usage on Survival in Previously Treated Advanced or Metastatic Melanoma in the UK. PLoS One. 2015 Dec 23;10(12):e0145524. doi: 10.1371/journal.pone.0145524. eCollection 2015.

Reference Type DERIVED
PMID: 26700304 (View on PubMed)

Koguchi Y, Hoen HM, Bambina SA, Rynning MD, Fuerstenberg RK, Curti BD, Urba WJ, Milburn C, Bahjat FR, Korman AJ, Bahjat KS. Serum Immunoregulatory Proteins as Predictors of Overall Survival of Metastatic Melanoma Patients Treated with Ipilimumab. Cancer Res. 2015 Dec 1;75(23):5084-92. doi: 10.1158/0008-5472.CAN-15-2303.

Reference Type DERIVED
PMID: 26627641 (View on PubMed)

Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

Reference Type DERIVED
PMID: 25667295 (View on PubMed)

Johnson DB, Friedman DL, Berry E, Decker I, Ye F, Zhao S, Morgans AK, Puzanov I, Sosman JA, Lovly CM. Survivorship in Immune Therapy: Assessing Chronic Immune Toxicities, Health Outcomes, and Functional Status among Long-term Ipilimumab Survivors at a Single Referral Center. Cancer Immunol Res. 2015 May;3(5):464-9. doi: 10.1158/2326-6066.CIR-14-0217. Epub 2015 Feb 3.

Reference Type DERIVED
PMID: 25649350 (View on PubMed)

McDermott D, Haanen J, Chen TT, Lorigan P, O'Day S; MDX010-20 investigators. Efficacy and safety of ipilimumab in metastatic melanoma patients surviving more than 2 years following treatment in a phase III trial (MDX010-20). Ann Oncol. 2013 Oct;24(10):2694-2698. doi: 10.1093/annonc/mdt291. Epub 2013 Aug 13.

Reference Type DERIVED
PMID: 23942774 (View on PubMed)

Robert C, Schadendorf D, Messina M, Hodi FS, O'Day S; MDX010-20 investigators. Efficacy and safety of retreatment with ipilimumab in patients with pretreated advanced melanoma who progressed after initially achieving disease control. Clin Cancer Res. 2013 Apr 15;19(8):2232-9. doi: 10.1158/1078-0432.CCR-12-3080. Epub 2013 Feb 26.

Reference Type DERIVED
PMID: 23444228 (View on PubMed)

Weber JS, Dummer R, de Pril V, Lebbe C, Hodi FS; MDX010-20 Investigators. Patterns of onset and resolution of immune-related adverse events of special interest with ipilimumab: detailed safety analysis from a phase 3 trial in patients with advanced melanoma. Cancer. 2013 May 1;119(9):1675-82. doi: 10.1002/cncr.27969. Epub 2013 Feb 7.

Reference Type DERIVED
PMID: 23400564 (View on PubMed)

Revicki DA, van den Eertwegh AJ, Lorigan P, Lebbe C, Linette G, Ottensmeier CH, Safikhani S, Messina M, Hoos A, Wagner S, Kotapati S. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual Life Outcomes. 2012 Jun 13;10:66. doi: 10.1186/1477-7525-10-66.

Reference Type DERIVED
PMID: 22694829 (View on PubMed)

Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbe C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711-23. doi: 10.1056/NEJMoa1003466. Epub 2010 Jun 5.

Reference Type DERIVED
PMID: 20525992 (View on PubMed)

Other Identifiers

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CA184-002

Identifier Type: OTHER

Identifier Source: secondary_id

MDX010-20

Identifier Type: -

Identifier Source: org_study_id

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