MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
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
2 other identifiers
interventional
1,783
13 countries
209
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2004
Longer than P75 for phase_3
209 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 21, 2004
CompletedFirst Posted
Study publicly available on registry
October 22, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
June 23, 2011
CompletedJuly 11, 2011
June 1, 2011
4.9 years
October 21, 2004
April 22, 2011
June 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.
From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
Secondary Outcomes (18)
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
From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
12-, 18-, and 24-Month Survival Rates
Month 12, Month 18, Month 24
Progression Free Survival (PFS)
From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24
Week 12, Week 24
Time to Progression (TTP)
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])
- +13 more secondary outcomes
Study Arms (3)
1
ACTIVE COMPARATORMelanoma Peptide Vaccine (MDX-1379) (gp100) + Placebo
2
EXPERIMENTALMDX-010 (ipilimumab) + MDX-1379 (gp100) (Melanoma Peptide Vaccine)
3
ACTIVE COMPARATORMDX-010 (ipilimumab) + Placebo
Interventions
3mg/kg (intravenous \[iv\] infusion over 90 minutes), every 3 weeks for 4 doses
2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (209)
Arizona Cancer Center
Tucson, Arizona, 85724, United States
University Medical Center
Tucson, Arizona, 85724, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
San Diego Cancer Center
Encinitas, California, 92024, United States
La Jolla Hematology and Oncology Medical Group
La Jolla, California, 92037, United States
Scripps Cancer Center
La Jolla, California, 92037, United States
Moores UCSD Cancer Center
La Jolla, California, 92093, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
Cancer Institute Medical Group, Inc
Los Angeles, California, 90025, United States
The Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
North County Oncology Medical Clinical, Inc.
Oceanside, California, 92056, United States
City of Hope Medical Group
Pasadena, California, 91105, United States
University of California, San Diego
San Diego, California, 92103, United States
St. Mary's Medical Center - Northern California Melanoma Center
San Francisco, California, 94109, United States
Cancer Institute Medical Group, Inc
Santa Monica, California, 90404, United States
San Diego Cancer Center
Vista, California, 92081, United States
Anschutz Cancer Pavilion
Aurora, Colorado, 80010, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
University of Colorado Health Sciences Center
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, 80304, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80909, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
University of Colorado Hospital
Denver, Colorado, 80262, United States
Rocky Mountain Cancer Centers
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers
Longmont, Colorado, 80501, United States
Yale University School of Medicine - Oncology Outpatient Clinic
New Haven, Connecticut, 06520, United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180, United States
Memorial Regional Cancer Center
Hollywood, Florida, 33021, United States
Shands Jacksonville
Jacksonville, Florida, 32209, United States
University of Florida/Jacksonville Faculty Clinic
Jacksonville, Florida, 32209, United States
Jackson Memorial Hospital & Clinics
Miami, Florida, 33136, United States
University of Miami Hospital & Clinics
Miami, Florida, 33136, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
M.D. Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Palm Beach Cancer Institute
Palm Beach Gardens, Florida, 33410, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Palm Beach Cancer Institute
Wellington, Florida, 33414, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Emory University Hospital-Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Cancer Care Specialists of Central IL
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Cancer Care Specialists of Central IL
Effingham, Illinois, 62401, United States
Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.
Maywood, Illinois, 60153, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46526, United States
Indiana Oncology Hematology Consultants North
Indianapolis, Indiana, 46202, United States
American Health Network of IN, LLC
Indianapolis, Indiana, 46237, United States
Indiana Oncology Hematology South
Indianapolis, Indiana, 46237, United States
Indiana Oncology Hematology Consutants of Noblesville
Noblesville, Indiana, 46060, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Norton Hospital
Louisville, Kentucky, 40202, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lutherville, Maryland, 21093, United States
Beth Isreal Dec Medical Center
Boston, Massachusetts, 02115, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Henry Ford Medical Center
Dearborn, Michigan, 48126, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Henry Ford Medical Center- West Bloomfield
West Bloomfield, Michigan, 48322, United States
Humphrey Cancer Center
Coon Rapids, Minnesota, 55433, United States
Humphrey Cancer Center
Fridley, Minnesota, 55432, United States
Hubert H Humphrey Cancer Center
Robbinsdale, Minnesota, 55422, United States
Family Cancer Center
Olive Branch, Mississippi, 38654, United States
Ellis Fischel Cancer Center
Columbia, Missouri, 65203, United States
St. Joseph Oncology, Inc
Saint Joseph, Missouri, 64507, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Washington Unv. School of Med./ Siteman Cancer Center
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Hematology-Oncology Associates of Northern NJ, PA
Morristown, New Jersey, 07962, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Overlook Oncology Center
Summit, New Jersey, 07901, United States
New Mexico Oncology Hematology Consultants, Ltd.
Albuquerque, New Mexico, 87109, United States
Hematology-Oncology Associates of CNY
East Syracuse, New York, 13057, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Columbia University Medical Center, Irving Center for Clinical Research
New York, New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7050, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
The Oregon Clinical
Portland, Oregon, 97213, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University Hosptital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Hillman Cancer Research Pavilion
Pittsburgh, Pennsylvania, 15213, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
Cancer Centers of the Carolinas
Easley, South Carolina, 29640, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615, United States
Cancer Centers of the Carolinas
Seneca, South Carolina, 29672, United States
Cancer Centers of the Carolinas
Spartanburg, South Carolina, 29307, United States
Family Cancer Center
Bartlett, Tennessee, 38133, United States
Family Cancer Center
Collierville, Tennessee, 38017, United States
Family Cancer Center
Memphis, Tennessee, 38119, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Arlington Cancer Center
Arlington, Texas, 76012, United States
Center for Oncology Research and Treatment
Dallas, Texas, 75230, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
Center for Oncology Research and Treatment
Richardson, Texas, 75080, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Fletcher Allen Health Care
Burlington, Vermont, 05405, United States
Hospital Municipal de Oncoligia Maria Curie
Ciudad de Buenos Aires, Buenos Aires, Argentina
Instituto Medico Platense
La Plata, Buenos Aires, 1900, Argentina
ISIS Clinica Especializada
Santa Fe, Santa Fe Province, Argentina
Hospital Militar Central
Buenos Aires, Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
Ciudad de Buenos Aires, C1280AEB, Argentina
Hospital Municipal de Oncologia Maria Curie
Ciudad de Buenos Aires, C1405BWU, Argentina
Hospital General de Agudos Carlos G. Durand
Ciudad de Buenos Aires, C1405DCS, Argentina
Instituto de Oncologia Angel H. Roffo
Ciudad de Buenos Aires, C1417DTB, Argentina
Hospital Militar Central
Ciudad de Buenos Aires, C1426BOS, Argentina
Instituto Alexander Fleming
Ciudad de Buenos Aires, C1426DRB, Argentina
Hospital Privado de Cordoba S.A.
CĂ³rdoba, X5016KEH, Argentina
Hospital Privado Centro Medico de Cordoba S.A.
CĂ³rdoba, Argentina
ISIS Clinica Especializada
Santa Fe, S3000FFU, Argentina
Institut Jules Bordet
Brussels, 1000, Belgium
Erasme Hospital, Free Universtiy of Brussels
Brussels, 1070, Belgium
Erasme Hospital
Brussels, 1070, Belgium
U.Z. Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, 3000, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, 5530, Belgium
Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias
GoiĂ¢nia, GoiĂ¡s, Brazil
Pro Onco Centro Tratamento Oncologico
Londrina, ParanĂ¡, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, SĂ£o Paulo, Brazil
Fundacoa Hospital Amaral Carvalho
JaĂº, SĂ£o Paulo, Brazil
Santo Andre Diagnosticos aTratamentos
Santo AndrĂ©, SĂ£o Paulo, Brazil
Sociedade Beneficante de Sennores - Hospital Sino Libante
SĂ£o Paulo, SĂ£o Paulo, Brazil
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos - SP, 14784-400, Brazil
Biocor - Hosp. de Doencas Cardiovasculares Ltda.
Belo Horizonte - MG, 34000-000, Brazil
Hospital Araujo Jorge
Goiania - GO, 74605-070, Brazil
Pro Onco Centro Tratemento Oncologico
Londrina - PR, 86050-190, Brazil
Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD
Porto Alegre, 90035-003, Brazil
Fund. SOAD / HC de Porto Alegre
Porto Alegre - RS, 90035-003, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre - RS, 90610-000, Brazil
Santo Andre Diagnosticos e Tratamentos Ltda.
Santo Andre-SP, 09090-780, Brazil
HC-FMUSP
Sao Paulo - SP, 05403-000, Brazil
Hospital Sirio Labanes
Sao Paulo-SP, 01308-050, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Cancer Centre of Southeastern Ontario at KGH
Kingston, Ontario, K7L 5P9, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Instituto Nacional del Cancer
Independencia, Santiago Metropolitan, Chile
Clinica Davila
Recoleta, Santiago Metropolitan, Chile
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, Chile
Hospital Barros Luco
Santiago, Santiago Metropolitan, Chile
Clinica Renaca
Reñaca, Vina Del Mar, Chile
Centre Oscar Lambret
Lille, 59020 Cedex, France
Centre Leon Berard
Lyon, 69373 Cedex 08, France
Hopital Sainte-Marguerite
Marseille, 13009, France
Hopital Saint-Eloi
Montpellier, 34295 Cedex 5, France
Hotel Dieu
Nantes, 44093 Cedex 1, France
Centre Antoine Lacassagne
Nice, 06189, France
Hopital Saint-Louis
Paris, 75010 10, France
Centre Eugene Marquis
Rennes, 35042 Cedex, France
Centre-Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42055 Cedex 2, France
Centre Alexis Vautrin
VandÅ“uvre-lès-Nancy, 54511 Cedex, France
Institut Gustave Roussy (IGR)
Villejuif, 94805 Cedex, France
Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie
Hufelandstr. 55, Hesse, 45122, Germany
Klinikum Augsburg
Augsburg, 86156, Germany
Charite Universitaets medizin Berlin
Berlin, 10117, Germany
Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12200, Germany
Universitaetsklinikum Dusseldorf
DĂ¼sseldorf, 40225, Germany
Universitaetsklinikum Erlangen
Erlangen, 91052, Germany
Universitaetsklinikum Essen
Essen, 45122, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69115, Germany
Klinikum der Friedrich-Schiller-Universitaet Jena
Jena, 07740, Germany
Klinikum Mannheim gGmbH
Mannheim, 68167, Germany
University of Mannheim
Mannheim, Germany
Klinikum Rechts der Isar / TU Muenchen
MĂ¼nchen, 81675, Germany
Universitaetsklinikum Tuebingen
TĂ¼bingen, 72076, Germany
Universitaetsklinikum Wuerzburg
WĂ¼rzburg, 97080, Germany
National Institute of Oncology
Budapest, H-1122, Hungary
University of Debrecen, Medical and Health Sciences Center
Debrecen, H-4012, Hungary
Semmelweis Hospital
Miskolc, H-3529, Hungary
University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center
Szeged, H-6720, Hungary
Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX, Netherlands
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, 1081 HV, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, 6229 HX, Netherlands
Mary Potter Oncology Centre
Groenkloof, 0181, South Africa
GVI Oncology
Panorama, 7500, South Africa
Mary Potter Oncology Centre
Pretoria, 0181, South Africa
Sandton Onocology Medical Research
Sandton, 2199, South Africa
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne, Rue Du Bugnon 46, CH-1011, Switzerland
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne, CH-1011, Switzerland
Dermatologische Klinik Universitatsspital Zurich
Zurich, 8091, Switzerland
St. Luke's Cancer Center, The Royal Surrey County Hospital
Guildford, Surry, GU2 7XX, United Kingdom
Velindre Hospital
Cardiff, CF14 2TL, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Christie Hospital
Manchester, M20 4BX, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Churchill Hospital
Oxford, OX3 7LJ, United Kingdom
Poole Hospital
Poole, BH15 2JB, United Kingdom
Weston Park Hospital
Sheffield, S10 2SJ, United Kingdom
Southampton General
Southampton, SO16 6YD, United Kingdom
Related Publications (10)
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.
PMID: 26700304DERIVEDKoguchi 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.
PMID: 26627641DERIVEDSchadendorf 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.
PMID: 25667295DERIVEDJohnson 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.
PMID: 25649350DERIVEDHatswell 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.
PMID: 25214238DERIVEDMcDermott 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.
PMID: 23942774DERIVEDRobert 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.
PMID: 23444228DERIVEDWeber 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.
PMID: 23400564DERIVEDRevicki 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.
PMID: 22694829DERIVEDHodi 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.
PMID: 20525992DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BMS Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 21, 2004
First Posted
October 22, 2004
Study Start
September 1, 2004
Primary Completion
August 1, 2009
Study Completion
October 1, 2009
Last Updated
July 11, 2011
Results First Posted
June 23, 2011
Record last verified: 2011-06