Clinical trial NCT00094653: MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
Official title: A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Metastases
Keywords: melanoma
metastatic melanoma
skin cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2004-10-22
Enrollment: 1783
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone
timeFrame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
Secondary outcomes:
measure: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy
timeFrame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
measure: 12-, 18-, and 24-Month Survival Rates
timeFrame: Month 12, Month 18, Month 24
measure: Progression Free Survival (PFS)
timeFrame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
measure: Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Time to Progression (TTP)
timeFrame: from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks])
measure: Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD)
timeFrame: BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1.
measure: Determination of Best Overall Response Rate (BORR)
timeFrame: Up to week 24
measure: Time to Response
timeFrame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
measure: Duration of Response
timeFrame: from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks])
measure: Disease Control Rate (DCR)
timeFrame: Up to week 24
measure: Delayed Response (Response Beyond Week 24)
timeFrame: from Week 24 to end of study (the end of the study was defined as the time at which 481 deaths were observed [264 weeks])
measure: Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12
timeFrame: Baseline (Day 1, Cycle1), Week 12
measure: Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death
timeFrame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).
measure: Percentage of Participants With Immune-Related Adverse Events (irAEs)
timeFrame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).
measure: Percentage of Participants With Worst On-Study Hematological Abnormalities
timeFrame: On-study laboratory results are results reported after the first dose date and within 70 days of last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).
measure: Percentage of Participants With Worst On-Study Liver Abnormalities
timeFrame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).
measure: Percentage of Participants With Worst On-Study Renal Abnormalities
timeFrame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).
measure: Clinically Meaningful Changes in Vital Signs and Physical Examinations
timeFrame: vital signs and physical examination were evaluated at screening and at Weeks 1, 4, 7, 10, 12, 16, 20, 24, 28, 36, and every 3 months thereafter
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Tucson
country: United States
facility: University Medical Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Encinitas
country: United States
facility: San Diego Cancer Center
state: California
city: La Jolla
country: United States
facility: La Jolla Hematology and Oncology Medical Group
state: California
city: La Jolla
country: United States
facility: Scripps Cancer Center
state: California
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: Cancer Institute Medical Group, Inc
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Oceanside
country: United States
facility: North County Oncology Medical Clinical, Inc.
state: California
city: Pasadena
country: United States
facility: City of Hope Medical Group
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: St. Mary's Medical Center - Northern California Melanoma Center
state: California
city: Santa Monica
country: United States
facility: Cancer Institute Medical Group, Inc
state: California
city: Vista
country: United States
facility: San Diego Cancer Center
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Pavilion
state: Colorado
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Longmont
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine - Oncology Outpatient Clinic
state: Connecticut
city: Aventura
country: United States
facility: Mount Sinai Comprehensive Cancer Center at Aventura
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: Shands Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: University of Florida/Jacksonville Faculty Clinic
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital & Clinics
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital & Clinics
state: Florida
city: Orlando
country: United States
facility: M.D. Anderson Cancer Center Orlando
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Wellington
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital-Winship Cancer Institute
state: Georgia
city: Decatur
country: United States
facility: Cancer Care Specialists of Central IL
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Effingham
country: United States
facility: Cancer Care Specialists of Central IL
state: Illinois
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.
state: Illinois
city: Goshen
country: United States
facility: Center for Cancer Care at Goshen Health System
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Oncology Hematology Consultants North
state: Indiana
city: Indianapolis
country: United States
facility: American Health Network of IN, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Oncology Hematology South
state: Indiana
city: Noblesville
country: United States
facility: Indiana Oncology Hematology Consutants of Noblesville
state: Indiana
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Baltimore
country: United States
facility: Franklin Square Hospital Center
state: Maryland
city: Lutherville
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Beth Isreal Dec Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Dearborn
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Medical Center- West Bloomfield
state: Michigan
city: Coon Rapids
country: United States
facility: Humphrey Cancer Center
state: Minnesota
city: Fridley
country: United States
facility: Humphrey Cancer Center
state: Minnesota
city: Robbinsdale
country: United States
facility: Hubert H Humphrey Cancer Center
state: Minnesota
city: Olive Branch
country: United States
facility: Family Cancer Center
state: Mississippi
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center
state: Missouri
city: St. Joseph
country: United States
facility: St. Joseph Oncology, Inc
state: Missouri
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: St. Louis
country: United States
facility: Washington Unv. School of Med./ Siteman Cancer Center
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: The Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Hematology-Oncology Associates of Northern NJ, PA
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
city: Summit
country: United States
facility: Overlook Oncology Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants, Ltd.
state: New Mexico
city: East Syracuse
country: United States
facility: Hematology-Oncology Associates of CNY
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center, Irving Center for Clinical Research
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: The Oregon Clinical
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hosptital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Hillman Cancer Research Pavilion
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Hillman Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Easley
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Seneca
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Spartanburg
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Bartlett
country: United States
facility: Family Cancer Center
state: Tennessee
city: Collierville
country: United States
facility: Family Cancer Center
state: Tennessee
city: Memphis
country: United States
facility: Family Cancer Center
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Richardson
country: United States
facility: Center for Oncology Research and Treatment
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Ciudad de Buenos Aires
country: Argentina
facility: Hospital Municipal de Oncoligia Maria Curie
state: Buenos Aires
city: La Plata
country: Argentina
facility: Instituto Medico Platense
state: Provincia de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Militar Central
city: Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
city: Ciudad de Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: Hospital Municipal de Oncologia Maria Curie
city: Ciudad de Buenos Aires
country: Argentina
facility: Hospital General de Agudos Carlos G. Durand
city: Ciudad de Buenos Aires
country: Argentina
facility: Instituto de Oncologia Angel H. Roffo
city: Ciudad de Buenos Aires
country: Argentina
facility: Hospital Militar Central
city: Ciudad de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
city: Cordoba
country: Argentina
facility: Hospital Privado de Cordoba S.A.
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba S.A.
city: Santa Fe
country: Argentina
facility: ISIS Clinica Especializada
city: Santa Fe
country: Argentina
facility: ISIS Clinica Especializada
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Erasme Hospital, Free Universtiy of Brussels
city: Brussels
country: Belgium
facility: Erasme Hospital
city: Gent
country: Belgium
facility: U.Z. Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Godinne
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias
state: GO
city: Londrina
country: Brazil
facility: Pro Onco Centro Tratamento Oncologico
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: RS
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos
state: SP
city: Jau
country: Brazil
facility: Fundacoa Hospital Amaral Carvalho
state: SP
city: Santo Andre
country: Brazil
facility: Santo Andre Diagnosticos aTratamentos
state: SP
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficante de Sennores - Hospital Sino Libante
state: SP
city: Barretos - SP
country: Brazil
facility: Hospital de Cancer de Barretos - Fundacao Pio XII
city: Belo Horizonte - MG
country: Brazil
facility: Biocor - Hosp. de Doencas Cardiovasculares Ltda.
city: Goiania - GO
country: Brazil
facility: Hospital Araujo Jorge
city: Londrina - PR
country: Brazil
facility: Pro Onco Centro Tratemento Oncologico
city: Porto Alegre - RS
country: Brazil
facility: Fund. SOAD / HC de Porto Alegre
city: Porto Alegre - RS
country: Brazil
facility: Hospital Sao Lucas - PUCRS
city: Porto Alegre
country: Brazil
facility: Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD
city: Santo Andre-SP
country: Brazil
facility: Santo Andre Diagnosticos e Tratamentos Ltda.
city: Sao Paulo - SP
country: Brazil
facility: HC-FMUSP
city: Sao Paulo-SP
country: Brazil
facility: Hospital Sirio Labanes
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: St. John's
country: Canada
facility: Dr. H. Bliss Murphy Cancer Centre
state: Newfoundland and Labrador
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario at KGH
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis - Jewish General Hospital
state: Quebec
city: Independencia
country: Chile
facility: Instituto Nacional del Cancer
state: Santiago
city: Recoleta
country: Chile
facility: Clinica Davila
state: Santiago
city: Renaca
country: Chile
facility: Clinica Renaca
state: Vina Del Mar
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez
city: Santiago
country: Chile
facility: Hospital Barros Luco
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Hopital Sainte-Marguerite
city: Montpellier
country: France
facility: Hopital Saint-Eloi
city: Nantes
country: France
facility: Hotel Dieu
city: Nice cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hopital Saint-Louis
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Saint-Etienne
country: France
facility: Centre-Hospitalier Universitaire de Saint-Etienne
city: Vandoeuvre les Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Institut Gustave Roussy (IGR)
city: Hufelandstr. 55
country: Germany
facility: Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie
state: Essen
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Charite Universitaets medizin Berlin
city: Berlin
country: Germany
facility: Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Heidelburg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Jena
country: Germany
facility: Klinikum der Friedrich-Schiller-Universitaet Jena
city: Mannheim
country: Germany
facility: Klinikum Mannheim gGmbH
city: Mannheim
country: Germany
facility: University of Mannheim
city: Muenchen
country: Germany
facility: Klinikum Rechts der Isar / TU Muenchen
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Debrecen
country: Hungary
facility: University of Debrecen, Medical and Health Sciences Center
city: Miskolc
country: Hungary
facility: Semmelweis Hospital
city: Szeged
country: Hungary
facility: University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center
city: Amsterdam
country: Netherlands
facility: Antoni Van Leeuwenhoek Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum (VUMC)
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Groenkloof
country: South Africa
facility: Mary Potter Oncology Centre
city: Panorama
country: South Africa
facility: GVI Oncology
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre
city: Sandton
country: South Africa
facility: Sandton Onocology Medical Research
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois - CHUV
state: Rue du Bugnon 46
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois - CHUV
city: Zurich
country: Switzerland
facility: Dermatologische Klinik Universitatsspital Zurich
city: Guildford
country: United Kingdom
facility: St. Luke's Cancer Center, The Royal Surrey County Hospital
state: Surry
city: Cardiff
country: United Kingdom
facility: Velindre Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Poole
country: United Kingdom
facility: Poole Hospital
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
city: Southampton
country: United Kingdom
facility: Southampton General
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.