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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00094653
Other study ID # MDX010-20
Secondary ID CA184-002
Status Completed
Phase Phase 3
First received October 21, 2004
Last updated June 29, 2011
Start date September 2004
Est. completion date October 2009

Study information

Verified date June 2011
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1783
Est. completion date October 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MDX-010 (anti-CTLA4) monoclonal antibody
3mg/kg (intravenous [iv] infusion over 90 minutes), every 3 weeks for 4 doses
Biological:
MDX-1379 (gp100) Melanoma Peptide Vaccine
2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.

Locations

Country Name City State
Argentina Hospital Militar Central Buenos Aires
Argentina Instituto Medico Especializado Alexander Fleming Buenos Aires
Argentina Hospital Britanico de Buenos Aires Ciudad de Buenos Aires
Argentina Hospital General de Agudos Carlos G. Durand Ciudad de Buenos Aires
Argentina Hospital Militar Central Ciudad de Buenos Aires
Argentina Hospital Municipal de Oncoligia Maria Curie Ciudad de Buenos Aires Buenos Aires
Argentina Hospital Municipal de Oncologia Maria Curie Ciudad de Buenos Aires
Argentina Instituto Alexander Fleming Ciudad de Buenos Aires
Argentina Instituto de Oncologia Angel H. Roffo Ciudad de Buenos Aires
Argentina Hospital Privado Centro Medico de Cordoba S.A. Cordoba
Argentina Hospital Privado de Cordoba S.A. Cordoba
Argentina Instituto Medico Platense La Plata Provincia de Buenos Aires
Argentina ISIS Clinica Especializada Santa Fe
Argentina ISIS Clinica Especializada Santa Fe
Belgium Erasme Hospital Brussels
Belgium Erasme Hospital, Free Universtiy of Brussels Brussels
Belgium Institut Jules Bordet Brussels
Belgium U.Z. Gent Gent
Belgium Universitair Ziekenhuis Gasthuisberg Leuven
Belgium Cliniques Universitaires UCL de Mont-Godinne Yvoir
Brazil Fundacao Pio XII - Hospital de Cancer de Barretos Barretos SP
Brazil Hospital de Cancer de Barretos - Fundacao Pio XII Barretos - SP
Brazil Biocor - Hosp. de Doencas Cardiovasculares Ltda. Belo Horizonte - MG
Brazil Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias Goiania GO
Brazil Hospital Araujo Jorge Goiania - GO
Brazil Fundacoa Hospital Amaral Carvalho Jau SP
Brazil Pro Onco Centro Tratamento Oncologico Londrina PR
Brazil Pro Onco Centro Tratemento Oncologico Londrina - PR
Brazil Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD Porto Alegre
Brazil Hospital Sao Lucas da PUCRS Porto Alegre RS
Brazil Fund. SOAD / HC de Porto Alegre Porto Alegre - RS
Brazil Hospital Sao Lucas - PUCRS Porto Alegre - RS
Brazil Santo Andre Diagnosticos aTratamentos Santo Andre SP
Brazil Santo Andre Diagnosticos e Tratamentos Ltda. Santo Andre-SP
Brazil Sociedade Beneficante de Sennores - Hospital Sino Libante Sao Paulo SP
Brazil HC-FMUSP Sao Paulo - SP
Brazil Hospital Sirio Labanes Sao Paulo-SP
Canada Tom Baker Cancer Centre Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada Cancer Centre of Southeastern Ontario at KGH Kingston Ontario
Canada London Regional Cancer Program London Ontario
Canada Sir Mortimer B. Davis - Jewish General Hospital Montreal Quebec
Canada The Ottawa Hospital Regional Cancer Centre Ottawa Ontario
Canada Dr. H. Bliss Murphy Cancer Centre St. John's Newfoundland and Labrador
Canada Princess Margaret Hospital Toronto Ontario
Canada CancerCare Manitoba Winnipeg Manitoba
Chile Instituto Nacional del Cancer Independencia Santiago
Chile Clinica Davila Recoleta Santiago
Chile Clinica Renaca Renaca Vina Del Mar
Chile Fundacion Arturo Lopez Perez Santiago
Chile Hospital Barros Luco Santiago
France Centre Oscar Lambret Lille
France Centre Leon Berard Lyon
France Hopital Sainte-Marguerite Marseille
France Hopital Saint-Eloi Montpellier
France Hotel Dieu Nantes
France Centre Antoine Lacassagne Nice cedex 2
France Hopital Saint-Louis Paris
France Centre Eugene Marquis Rennes
France Centre-Hospitalier Universitaire de Saint-Etienne Saint-Etienne
France Centre Alexis Vautrin Vandoeuvre les Nancy
France Institut Gustave Roussy (IGR) Villejuif
Germany Klinikum Augsburg Augsburg
Germany Charite Universitaets medizin Berlin Berlin
Germany Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin Berlin
Germany Universitaetsklinikum Dusseldorf Duesseldorf
Germany Universitaetsklinikum Erlangen Erlangen
Germany Universitaetsklinikum Essen Essen
Germany Universitaetsklinikum Heidelberg Heidelburg
Germany Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie Hufelandstr. 55 Essen
Germany Klinikum der Friedrich-Schiller-Universitaet Jena Jena
Germany Klinikum Mannheim gGmbH Mannheim
Germany University of Mannheim Mannheim
Germany Klinikum Rechts der Isar / TU Muenchen Muenchen
Germany Universitaetsklinikum Tuebingen Tuebingen
Germany Universitaetsklinikum Wuerzburg Wuerzburg
Hungary National Institute of Oncology Budapest
Hungary University of Debrecen, Medical and Health Sciences Center Debrecen
Hungary Semmelweis Hospital Miskolc
Hungary University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center Szeged
Netherlands Antoni Van Leeuwenhoek Ziekenhuis Amsterdam
Netherlands Vrije Universiteit Medisch Centrum (VUMC) Amsterdam
Netherlands Academisch Ziekenhuis Maastricht Maastricht
South Africa Mary Potter Oncology Centre Groenkloof
South Africa GVI Oncology Panorama
South Africa Mary Potter Oncology Centre Pretoria
South Africa Sandton Onocology Medical Research Sandton
Switzerland Centre Hospitalier Universitaire Vaudois - CHUV Lausanne Rue du Bugnon 46
Switzerland Centre Hospitalier Universitaire Vaudois - CHUV Lausanne
Switzerland Dermatologische Klinik Universitatsspital Zurich Zurich
United Kingdom Velindre Hospital Cardiff
United Kingdom Ninewells Hospital Dundee
United Kingdom St. Luke's Cancer Center, The Royal Surrey County Hospital Guildford Surry
United Kingdom Christie Hospital Manchester
United Kingdom Nottingham City Hospital Nottingham
United Kingdom Churchill Hospital Oxford
United Kingdom Poole Hospital Poole
United Kingdom Weston Park Hospital Sheffield
United Kingdom Southampton General Southampton
United States New Mexico Oncology Hematology Consultants, Ltd. Albuquerque New Mexico
United States Arlington Cancer Center Arlington Texas
United States Emory University Hospital-Winship Cancer Institute Atlanta Georgia
United States Anschutz Cancer Pavilion Aurora Colorado
United States Rocky Mountain Cancer Centers Aurora Colorado
United States University of Colorado Health Sciences Center Aurora Colorado
United States Mount Sinai Comprehensive Cancer Center at Aventura Aventura Florida
United States Franklin Square Hospital Center Baltimore Maryland
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Family Cancer Center Bartlett Tennessee
United States Beth Isreal Dec Medical Center Boston Massachusetts
United States Brigham and Womens Hospital Boston Massachusetts
United States Dana Farber Cancer Institute Boston Massachusetts
United States Rocky Mountain Cancer Centers Boulder Colorado
United States Fletcher Allen Health Care Burlington Vermont
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States The Christ Hospital Cancer Center Cincinnati Ohio
United States The Cleveland Clinic Foundation Cleveland Ohio
United States Family Cancer Center Collierville Tennessee
United States Rocky Mountain Cancer Centers Colorado Springs Colorado
United States Ellis Fischel Cancer Center Columbia Missouri
United States Humphrey Cancer Center Coon Rapids Minnesota
United States Center for Oncology Research and Treatment Dallas Texas
United States Henry Ford Medical Center Dearborn Michigan
United States Cancer Care Specialists of Central IL Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Rocky Mountain Cancer Centers Denver Colorado
United States University of Colorado Hospital Denver Colorado
United States Henry Ford Hospital Detroit Michigan
United States City of Hope National Medical Center Duarte California
United States Cancer Centers of the Carolinas Easley South Carolina
United States Hematology-Oncology Associates of CNY East Syracuse New York
United States Cancer Care Specialists of Central IL Effingham Illinois
United States San Diego Cancer Center Encinitas California
United States Humphrey Cancer Center Fridley Minnesota
United States Center for Cancer Care at Goshen Health System Goshen Indiana
United States Cancer Centers of the Carolinas Greenville South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States The Cancer Center at Hackensack University Medical Center Hackensack New Jersey
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States Memorial Regional Cancer Center Hollywood Florida
United States American Health Network of IN, LLC Indianapolis Indiana
United States Indiana Oncology Hematology Consultants North Indianapolis Indiana
United States Indiana Oncology Hematology South Indianapolis Indiana
United States Shands Jacksonville Jacksonville Florida
United States University of Florida/Jacksonville Faculty Clinic Jacksonville Florida
United States La Jolla Hematology and Oncology Medical Group La Jolla California
United States Moores UCSD Cancer Center La Jolla California
United States Scripps Cancer Center La Jolla California
United States Rocky Mountain Cancer Centers Lakewood Colorado
United States Central Baptist Hospital Lexington Kentucky
United States Rocky Mountain Cancer Centers Littleton Colorado
United States Rocky Mountain Cancer Centers Lone Tree Colorado
United States Pacific Shores Medical Group Long Beach California
United States Rocky Mountain Cancer Centers Longmont Colorado
United States Cancer Institute Medical Group, Inc Los Angeles California
United States The Angeles Clinic and Research Institute Los Angeles California
United States USC/Norris Comprehensive Cancer Center Los Angeles California
United States James Graham Brown Cancer Center Louisville Kentucky
United States Norton Hospital Louisville Kentucky
United States University of Louisville Hospital Louisville Kentucky
United States Joe Arrington Cancer Research and Treatment Center Lubbock Texas
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Lutherville Maryland
United States Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr. Maywood Illinois
United States Family Cancer Center Memphis Tennessee
United States The West Clinic Memphis Tennessee
United States Jackson Memorial Hospital & Clinics Miami Florida
United States University of Miami Hospital & Clinics Miami Florida
United States Mount Sinai Comprehensive Cancer Center Miami Beach Florida
United States Mount Sinai Medical Center Miami Beach Florida
United States Hematology-Oncology Associates of Northern NJ, PA Morristown New Jersey
United States Vanderbilt University Medical Center Nashville Tennessee
United States Robert Wood Johnson University Hospital New Brunswick New Jersey
United States The Cancer Institute of New Jersey New Brunswick New Jersey
United States Yale University School of Medicine - Oncology Outpatient Clinic New Haven Connecticut
United States Columbia University Medical Center, Irving Center for Clinical Research New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Indiana Oncology Hematology Consutants of Noblesville Noblesville Indiana
United States North County Oncology Medical Clinical, Inc. Oceanside California
United States Family Cancer Center Olive Branch Mississippi
United States M.D. Anderson Cancer Center Orlando Orlando Florida
United States Palm Beach Cancer Institute Palm Beach Gardens Florida
United States City of Hope Medical Group Pasadena California
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Thomas Jefferson University Hosptital Philadelphia Pennsylvania
United States Hillman Cancer Center Pittsburgh Pennsylvania
United States Hillman Cancer Research Pavilion Pittsburgh Pennsylvania
United States University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania
United States Providence Portland Medical Center Portland Oregon
United States The Oregon Clinical Portland Oregon
United States Center for Oncology Research and Treatment Richardson Texas
United States Hubert H Humphrey Cancer Center Robbinsdale Minnesota
United States Huntsman Cancer Institute Salt Lake City Utah
United States Huntsman Cancer Institute Salt Lake City Utah
United States University of California, San Diego San Diego California
United States St. Mary's Medical Center - Northern California Melanoma Center San Francisco California
United States Cancer Institute Medical Group, Inc Santa Monica California
United States Cancer Centers of the Carolinas Seneca South Carolina
United States Cancer Centers of the Carolinas Spartanburg South Carolina
United States St. Joseph Oncology, Inc St. Joseph Missouri
United States Barnes Jewish Hospital St. Louis Missouri
United States Washington Unv. School of Med./ Siteman Cancer Center St. Louis Missouri
United States Overlook Oncology Center Summit New Jersey
United States H. Lee Moffitt Cancer Center & Research Institute Tampa Florida
United States Arizona Cancer Center Tucson Arizona
United States University Medical Center Tucson Arizona
United States San Diego Cancer Center Vista California
United States Palm Beach Cancer Institute Wellington Florida
United States Henry Ford Medical Center- West Bloomfield West Bloomfield Michigan
United States Palm Beach Cancer Institute West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary 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 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) No
Secondary 12-, 18-, and 24-Month Survival Rates The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials. Month 12, Month 18, Month 24 No
Secondary Progression Free Survival (PFS) PFS was defined as the number of days between the date of randomization and the date of the progression or the date of death. A subject who died without prior progression was considered to have progressed on the date of death. PFS was determined by investigator. 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) No
Secondary Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24 PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. Week 12, Week 24 No
Secondary Time to Progression (TTP) TTP was defined as the number of days between the date of the randomization and date of PD or death due to PD. For subjects who had not progression and remained alive, TTP was censored on the date of last assessment; those who remained alive and had no recorded post-baseline assessment, TTP was censored on the date of randomization; those who remained alive and had randomized but were not treated, TTP was censored at the date of randomization; for those who died without reported disease progression, TTP was censored on the date of death. 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]) No
Secondary Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD) Investigator's assessment, modified World Health Organization criteria. CR: disappearance of all lesions by 2 consecutive observations >=4 weeks apart, no evidence of PD. PR: >=50% ? in sum of products of longest diameter & greatest perpendicular diameter of all target lesions compared to baseline by 2 observations >=4 weeks apart. SD: Neither sufficient ? to qualify for PR nor sufficient ? to qualify for PD. PD: ? >=25% in sum of products of longest diameter & greatest perpendicular diameter of target lesions compared to smallest recorded sum during study, or appearance of >= 1 new lesion. BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1. No
Secondary Determination of Best Overall Response Rate (BORR) Response was based on the investigators' assessment using modified WHO criteria. BORR is defined as the number of subjects whose BOR is complete or partial response (CR or PR) divided by the total number of subjects in the group. BORR was comprised of responder and non-responder. The definition of a responder in BORR was either confirmed CR or PR, and a non-responder was defined as stable disease (SD), progressed disease (PD), unconfirmed CR (uCR), unconfirmed PR (uPR), and not evaluated. Up to week 24 No
Secondary Time to Response Time to response was defined as the number of days from the date of randomization to the date when measurement criteria are met for BOR of CR or PR, as determined by investigator. From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) No
Secondary Duration of Response Kaplan-Meier medians along with Brookmeyer and Crowley 95% confidence intervals (CI) for were computed. Duration of response was defined in subjects whose BOR was CR or PR as the number of days between the date of response (CR or PR) and the date of PD or the date of death (whichever occurs first). 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]) No
Secondary Disease Control Rate (DCR) Response was based on the investigators' assessment using modified WHO criteria. DCR is defined as the number of subjects whose BOR is CR, PR, or SD divided by the total number of subjects in the group. Up to week 24 No
Secondary Delayed Response (Response Beyond Week 24) Response was based on the investigators' assessment using modified World Health Organization (WHO) criteria. Delayed response is defined as post Week 24 overall response for the subjects who have PD before or at Week 24. Evaluation of delayed overall response is compared to baseline assessment. Delayed response includes delayed late CR, delayed late PR, delayed late SD, continued PD, unknown, and missing after Week 24. The delayed response of CR and PR also must have been confirmed. 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]) No
Secondary 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 The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe). Baseline (Day 1, Cycle1), Week 12 No
Secondary Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death An AE was defined as any undesirable sign, symptom, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be treatment-related. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. If CTCAE grading does not exist for an adverse event, the intensity of mild (1), moderate (2), severe (3), and life-threatening (4) were used. 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]). Yes
Secondary Percentage of Participants With Immune-Related Adverse Events (irAEs) An immune related adverse event (irAE) was defined as an adverse event of unknown etiology, associated with study drug exposure and consistent with an immune phenomenon. The irAEs were programmatically determined from a predefined list of MedDRA version 12.0 high-level group terms, high-level terms and preferred terms of all ipilimumab related adverse event. The category of "Other irAEs" includes blood, eye, immune, infections, renal, and respiratory systems. 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]). Yes
Secondary Percentage of Participants With Worst On-Study Hematological Abnormalities ANC=Absolute Neutrophil Count. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE. 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]). Yes
Secondary Percentage of Participants With Worst On-Study Liver Abnormalities ALT=alanine aminotransferase; AST=aspartate aminotransferase. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE. 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]). Yes
Secondary Percentage of Participants With Worst On-Study Renal Abnormalities CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE. 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]). Yes
Secondary Clinically Meaningful Changes in Vital Signs and Physical Examinations Clinically meaningful changes were according to investigator. Vital sign measurements include height, weight, temperature, pulse, and resting systolic and diastolic blood pressure. 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 Yes
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