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

Primary Purpose

Melanoma, Metastases

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MDX-010 (anti-CTLA4) monoclonal antibody
MDX-1379 (gp100) Melanoma Peptide Vaccine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring melanoma, metastatic melanoma, skin cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Cancer Center
  • University Medical Center
  • City of Hope National Medical Center
  • San Diego Cancer Center
  • La Jolla Hematology and Oncology Medical Group
  • Scripps Cancer Center
  • Moores UCSD Cancer Center
  • Pacific Shores Medical Group
  • Cancer Institute Medical Group, Inc
  • The Angeles Clinic and Research Institute
  • USC/Norris Comprehensive Cancer Center
  • North County Oncology Medical Clinical, Inc.
  • City of Hope Medical Group
  • University of California, San Diego
  • St. Mary's Medical Center - Northern California Melanoma Center
  • Cancer Institute Medical Group, Inc
  • San Diego Cancer Center
  • Anschutz Cancer Pavilion
  • Rocky Mountain Cancer Centers
  • University of Colorado Health Sciences Center
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • University of Colorado Hospital
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Yale University School of Medicine - Oncology Outpatient Clinic
  • Mount Sinai Comprehensive Cancer Center at Aventura
  • Memorial Regional Cancer Center
  • Shands Jacksonville
  • University of Florida/Jacksonville Faculty Clinic
  • Mount Sinai Comprehensive Cancer Center
  • Mount Sinai Medical Center
  • Jackson Memorial Hospital & Clinics
  • University of Miami Hospital & Clinics
  • M.D. Anderson Cancer Center Orlando
  • Palm Beach Cancer Institute
  • H. Lee Moffitt Cancer Center & Research Institute
  • Palm Beach Cancer Institute
  • Palm Beach Cancer Institute
  • Emory University Hospital-Winship Cancer Institute
  • Cancer Care Specialists of Central IL
  • Decatur Memorial Hospital
  • Cancer Care Specialists of Central IL
  • Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.
  • Center for Cancer Care at Goshen Health System
  • Indiana Oncology Hematology Consultants North
  • American Health Network of IN, LLC
  • Indiana Oncology Hematology South
  • Indiana Oncology Hematology Consutants of Noblesville
  • Central Baptist Hospital
  • James Graham Brown Cancer Center
  • Norton Hospital
  • University of Louisville Hospital
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Franklin Square Hospital Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Beth Isreal Dec Medical Center
  • Brigham and Womens Hospital
  • Dana Farber Cancer Institute
  • Henry Ford Medical Center
  • Henry Ford Hospital
  • Henry Ford Medical Center- West Bloomfield
  • Humphrey Cancer Center
  • Humphrey Cancer Center
  • Hubert H Humphrey Cancer Center
  • Family Cancer Center
  • Ellis Fischel Cancer Center
  • St. Joseph Oncology, Inc
  • Barnes Jewish Hospital
  • Washington Unv. School of Med./ Siteman Cancer Center
  • Hackensack University Medical Center
  • The Cancer Center at Hackensack University Medical Center
  • Hematology-Oncology Associates of Northern NJ, PA
  • Robert Wood Johnson University Hospital
  • The Cancer Institute of New Jersey
  • Overlook Oncology Center
  • New Mexico Oncology Hematology Consultants, Ltd.
  • Hematology-Oncology Associates of CNY
  • Memorial Sloan Kettering Cancer Center
  • Columbia University Medical Center, Irving Center for Clinical Research
  • University of North Carolina at Chapel Hill
  • The Christ Hospital Cancer Center
  • The Cleveland Clinic Foundation
  • Providence Portland Medical Center
  • The Oregon Clinical
  • Penn State Milton S. Hershey Medical Center
  • Thomas Jefferson University Hosptital
  • Fox Chase Cancer Center
  • Hillman Cancer Research Pavilion
  • Hillman Cancer Center
  • University of Pittsburgh Cancer Institute
  • Cancer Centers of the Carolinas
  • Cancer Centers of the Carolinas
  • Cancer Centers of the Carolinas
  • Cancer Centers of the Carolinas
  • Family Cancer Center
  • Family Cancer Center
  • Family Cancer Center
  • The West Clinic
  • Vanderbilt University Medical Center
  • Arlington Cancer Center
  • Center for Oncology Research and Treatment
  • Joe Arrington Cancer Research and Treatment Center
  • Center for Oncology Research and Treatment
  • Huntsman Cancer Institute
  • Huntsman Cancer Institute
  • Fletcher Allen Health Care
  • Hospital Municipal de Oncoligia Maria Curie
  • Instituto Medico Platense
  • Hospital Militar Central
  • Instituto Medico Especializado Alexander Fleming
  • Hospital Britanico de Buenos Aires
  • Hospital Municipal de Oncologia Maria Curie
  • Hospital General de Agudos Carlos G. Durand
  • Instituto de Oncologia Angel H. Roffo
  • Hospital Militar Central
  • Instituto Alexander Fleming
  • Hospital Privado de Cordoba S.A.
  • Hospital Privado Centro Medico de Cordoba S.A.
  • ISIS Clinica Especializada
  • ISIS Clinica Especializada
  • Institut Jules Bordet
  • Erasme Hospital, Free Universtiy of Brussels
  • Erasme Hospital
  • U.Z. Gent
  • Universitair Ziekenhuis Gasthuisberg
  • Cliniques Universitaires UCL de Mont-Godinne
  • Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias
  • Pro Onco Centro Tratamento Oncologico
  • Hospital Sao Lucas da PUCRS
  • Fundacao Pio XII - Hospital de Cancer de Barretos
  • Fundacoa Hospital Amaral Carvalho
  • Santo Andre Diagnosticos aTratamentos
  • Sociedade Beneficante de Sennores - Hospital Sino Libante
  • Hospital de Cancer de Barretos - Fundacao Pio XII
  • Biocor - Hosp. de Doencas Cardiovasculares Ltda.
  • Hospital Araujo Jorge
  • Pro Onco Centro Tratemento Oncologico
  • Fund. SOAD / HC de Porto Alegre
  • Hospital Sao Lucas - PUCRS
  • Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD
  • Santo Andre Diagnosticos e Tratamentos Ltda.
  • HC-FMUSP
  • Hospital Sirio Labanes
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • CancerCare Manitoba
  • Dr. H. Bliss Murphy Cancer Centre
  • Cancer Centre of Southeastern Ontario at KGH
  • London Regional Cancer Program
  • The Ottawa Hospital Regional Cancer Centre
  • Princess Margaret Hospital
  • Sir Mortimer B. Davis - Jewish General Hospital
  • Instituto Nacional del Cancer
  • Clinica Davila
  • Clinica Renaca
  • Fundacion Arturo Lopez Perez
  • Hospital Barros Luco
  • Centre Oscar Lambret
  • Centre Leon Berard
  • Hopital Sainte-Marguerite
  • Hopital Saint-Eloi
  • Hotel Dieu
  • Centre Antoine Lacassagne
  • Hopital Saint-Louis
  • Centre Eugene Marquis
  • Centre-Hospitalier Universitaire de Saint-Etienne
  • Centre Alexis Vautrin
  • Institut Gustave Roussy (IGR)
  • Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie
  • Klinikum Augsburg
  • Charite Universitaets medizin Berlin
  • Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
  • Universitaetsklinikum Dusseldorf
  • Universitaetsklinikum Erlangen
  • Universitaetsklinikum Essen
  • Universitaetsklinikum Heidelberg
  • Klinikum der Friedrich-Schiller-Universitaet Jena
  • Klinikum Mannheim gGmbH
  • University of Mannheim
  • Klinikum Rechts der Isar / TU Muenchen
  • Universitaetsklinikum Tuebingen
  • Universitaetsklinikum Wuerzburg
  • National Institute of Oncology
  • University of Debrecen, Medical and Health Sciences Center
  • Semmelweis Hospital
  • University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center
  • Antoni Van Leeuwenhoek Ziekenhuis
  • Vrije Universiteit Medisch Centrum (VUMC)
  • Academisch Ziekenhuis Maastricht
  • Mary Potter Oncology Centre
  • GVI Oncology
  • Mary Potter Oncology Centre
  • Sandton Onocology Medical Research
  • Centre Hospitalier Universitaire Vaudois - CHUV
  • Centre Hospitalier Universitaire Vaudois - CHUV
  • Dermatologische Klinik Universitatsspital Zurich
  • St. Luke's Cancer Center, The Royal Surrey County Hospital
  • Velindre Hospital
  • Ninewells Hospital
  • Christie Hospital
  • Nottingham City Hospital
  • Churchill Hospital
  • Poole Hospital
  • Weston Park Hospital
  • Southampton General

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

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

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

MDX-010 (ipilimumab) + Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 21, 2004
Last Updated
June 29, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00094653
Brief Title
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

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Metastases
Keywords
melanoma, metastatic melanoma, skin cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1783 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Melanoma Peptide Vaccine (MDX-1379) (gp100) + Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
MDX-010 (ipilimumab) + MDX-1379 (gp100) (Melanoma Peptide Vaccine)
Arm Title
3
Arm Type
Active Comparator
Arm Description
MDX-010 (ipilimumab) + Placebo
Intervention Type
Drug
Intervention Name(s)
MDX-010 (anti-CTLA4) monoclonal antibody
Other Intervention Name(s)
ipilimumab
Intervention Description
3mg/kg (intravenous [iv] infusion over 90 minutes), every 3 weeks for 4 doses
Intervention Type
Biological
Intervention Name(s)
MDX-1379 (gp100) Melanoma Peptide Vaccine
Other Intervention Name(s)
melanoma peptide vaccine
Intervention Description
2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
Title
12-, 18-, and 24-Month Survival Rates
Description
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.
Time Frame
Month 12, Month 18, Month 24
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
Title
Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24
Description
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.
Time Frame
Week 12, Week 24
Title
Time to Progression (TTP)
Description
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.
Time Frame
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])
Title
Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD)
Description
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.
Time Frame
BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1.
Title
Determination of Best Overall Response Rate (BORR)
Description
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.
Time Frame
Up to week 24
Title
Time to Response
Description
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.
Time Frame
From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
Title
Duration of Response
Description
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).
Time Frame
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])
Title
Disease Control Rate (DCR)
Description
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.
Time Frame
Up to week 24
Title
Delayed Response (Response Beyond Week 24)
Description
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.
Time Frame
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])
Title
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
Description
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).
Time Frame
Baseline (Day 1, Cycle1), Week 12
Title
Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death
Description
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.
Time Frame
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]).
Title
Percentage of Participants With Immune-Related Adverse Events (irAEs)
Description
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.
Time Frame
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]).
Title
Percentage of Participants With Worst On-Study Hematological Abnormalities
Description
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.
Time Frame
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]).
Title
Percentage of Participants With Worst On-Study Liver Abnormalities
Description
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.
Time Frame
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]).
Title
Percentage of Participants With Worst On-Study Renal Abnormalities
Description
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.
Time Frame
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]).
Title
Clinically Meaningful Changes in Vital Signs and Physical Examinations
Description
Clinically meaningful changes were according to investigator. Vital sign measurements include height, weight, temperature, pulse, and resting systolic and diastolic blood pressure.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
San Diego Cancer Center
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
La Jolla Hematology and Oncology Medical Group
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Scripps Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Cancer Institute Medical Group, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
The Angeles Clinic and Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
North County Oncology Medical Clinical, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
City of Hope Medical Group
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
St. Mary's Medical Center - Northern California Melanoma Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Cancer Institute Medical Group, Inc
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
San Diego Cancer Center
City
Vista
State/Province
California
ZIP/Postal Code
92081
Country
United States
Facility Name
Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University of Colorado Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Yale University School of Medicine - Oncology Outpatient Clinic
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center at Aventura
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Memorial Regional Cancer Center
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Shands Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
University of Florida/Jacksonville Faculty Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Jackson Memorial Hospital & Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Hospital & Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
M.D. Anderson Cancer Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Palm Beach Cancer Institute
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Palm Beach Cancer Institute
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Emory University Hospital-Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Cancer Care Specialists of Central IL
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Cancer Care Specialists of Central IL
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Center for Cancer Care at Goshen Health System
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Indiana Oncology Hematology Consultants North
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
American Health Network of IN, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Indiana Oncology Hematology South
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Indiana Oncology Hematology Consutants of Noblesville
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46060
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Franklin Square Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Beth Isreal Dec Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Henry Ford Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Henry Ford Medical Center- West Bloomfield
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Humphrey Cancer Center
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Humphrey Cancer Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Hubert H Humphrey Cancer Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Family Cancer Center
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Ellis Fischel Cancer Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
St. Joseph Oncology, Inc
City
St. Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Barnes Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington Unv. School of Med./ Siteman Cancer Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
The Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Hematology-Oncology Associates of Northern NJ, PA
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
The Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Overlook Oncology Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
New Mexico Oncology Hematology Consultants, Ltd.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Hematology-Oncology Associates of CNY
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center, Irving Center for Clinical Research
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7050
Country
United States
Facility Name
The Christ Hospital Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
The Oregon Clinical
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Thomas Jefferson University Hosptital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Hillman Cancer Research Pavilion
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Family Cancer Center
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Family Cancer Center
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
Family Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Center for Oncology Research and Treatment
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Center for Oncology Research and Treatment
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5550
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Hospital Municipal de Oncoligia Maria Curie
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
Country
Argentina
Facility Name
Instituto Medico Platense
City
La Plata
State/Province
Provincia de Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Hospital Militar Central
City
Buenos Aires
Country
Argentina
Facility Name
Instituto Medico Especializado Alexander Fleming
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Hospital Municipal de Oncologia Maria Curie
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1405BWU
Country
Argentina
Facility Name
Hospital General de Agudos Carlos G. Durand
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1405DCS
Country
Argentina
Facility Name
Instituto de Oncologia Angel H. Roffo
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1417DTB
Country
Argentina
Facility Name
Hospital Militar Central
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1426BOS
Country
Argentina
Facility Name
Instituto Alexander Fleming
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1426DRB
Country
Argentina
Facility Name
Hospital Privado de Cordoba S.A.
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Hospital Privado Centro Medico de Cordoba S.A.
City
Cordoba
Country
Argentina
Facility Name
ISIS Clinica Especializada
City
Santa Fe
ZIP/Postal Code
S3000FFU
Country
Argentina
Facility Name
ISIS Clinica Especializada
City
Santa Fe
Country
Argentina
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Erasme Hospital, Free Universtiy of Brussels
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
U.Z. Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cliniques Universitaires UCL de Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias
City
Goiania
State/Province
GO
Country
Brazil
Facility Name
Pro Onco Centro Tratamento Oncologico
City
Londrina
State/Province
PR
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
Country
Brazil
Facility Name
Fundacoa Hospital Amaral Carvalho
City
Jau
State/Province
SP
Country
Brazil
Facility Name
Santo Andre Diagnosticos aTratamentos
City
Santo Andre
State/Province
SP
Country
Brazil
Facility Name
Sociedade Beneficante de Sennores - Hospital Sino Libante
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Hospital de Cancer de Barretos - Fundacao Pio XII
City
Barretos - SP
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Biocor - Hosp. de Doencas Cardiovasculares Ltda.
City
Belo Horizonte - MG
ZIP/Postal Code
34000-000
Country
Brazil
Facility Name
Hospital Araujo Jorge
City
Goiania - GO
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Pro Onco Centro Tratemento Oncologico
City
Londrina - PR
ZIP/Postal Code
86050-190
Country
Brazil
Facility Name
Fund. SOAD / HC de Porto Alegre
City
Porto Alegre - RS
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre - RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Santo Andre Diagnosticos e Tratamentos Ltda.
City
Santo Andre-SP
ZIP/Postal Code
09090-780
Country
Brazil
Facility Name
HC-FMUSP
City
Sao Paulo - SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Hospital Sirio Labanes
City
Sao Paulo-SP
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Dr. H. Bliss Murphy Cancer Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at KGH
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Sir Mortimer B. Davis - Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Instituto Nacional del Cancer
City
Independencia
State/Province
Santiago
Country
Chile
Facility Name
Clinica Davila
City
Recoleta
State/Province
Santiago
Country
Chile
Facility Name
Clinica Renaca
City
Renaca
State/Province
Vina Del Mar
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez
City
Santiago
Country
Chile
Facility Name
Hospital Barros Luco
City
Santiago
Country
Chile
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020 Cedex
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373 Cedex 08
Country
France
Facility Name
Hopital Sainte-Marguerite
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Hopital Saint-Eloi
City
Montpellier
ZIP/Postal Code
34295 Cedex 5
Country
France
Facility Name
Hotel Dieu
City
Nantes
ZIP/Postal Code
44093 Cedex 1
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010 10
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042 Cedex
Country
France
Facility Name
Centre-Hospitalier Universitaire de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055 Cedex 2
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511 Cedex
Country
France
Facility Name
Institut Gustave Roussy (IGR)
City
Villejuif
ZIP/Postal Code
94805 Cedex
Country
France
Facility Name
Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie
City
Hufelandstr. 55
State/Province
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Charite Universitaets medizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitaetsklinikum Dusseldorf
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelburg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Klinikum der Friedrich-Schiller-Universitaet Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Klinikum Mannheim gGmbH
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
University of Mannheim
City
Mannheim
Country
Germany
Facility Name
Klinikum Rechts der Isar / TU Muenchen
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
H-1122
Country
Hungary
Facility Name
University of Debrecen, Medical and Health Sciences Center
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Facility Name
Semmelweis Hospital
City
Miskolc
ZIP/Postal Code
H-3529
Country
Hungary
Facility Name
University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Antoni Van Leeuwenhoek Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum (VUMC)
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Mary Potter Oncology Centre
City
Groenkloof
ZIP/Postal Code
0181
Country
South Africa
Facility Name
GVI Oncology
City
Panorama
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Mary Potter Oncology Centre
City
Pretoria
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Sandton Onocology Medical Research
City
Sandton
ZIP/Postal Code
2199
Country
South Africa
Facility Name
Centre Hospitalier Universitaire Vaudois - CHUV
City
Lausanne
State/Province
Rue du Bugnon 46
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois - CHUV
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Dermatologische Klinik Universitatsspital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
St. Luke's Cancer Center, The Royal Surrey County Hospital
City
Guildford
State/Province
Surry
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Velindre Hospital
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Poole Hospital
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Southampton General
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26700304
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.
Results Reference
derived
PubMed Identifier
26627641
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.
Results Reference
derived
PubMed Identifier
25667295
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.
Results Reference
derived
PubMed Identifier
25649350
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.
Results Reference
derived
PubMed Identifier
25214238
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.
Results Reference
derived
PubMed Identifier
23942774
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.
Results Reference
derived
PubMed Identifier
23444228
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.
Results Reference
derived
PubMed Identifier
23400564
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.
Results Reference
derived
PubMed Identifier
22694829
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.
Results Reference
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PubMed Identifier
20525992
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. Erratum In: N Engl J Med. 2010 Sep 23;363(13):1290.
Results Reference
derived

Learn more about this trial

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

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