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

June 29, 2011 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1783

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Melanoma Peptide Vaccine (MDX-1379) (gp100) + Placebo
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.
Other Names:
  • melanoma peptide vaccine
Experimental: 2
MDX-010 (ipilimumab) + MDX-1379 (gp100) (Melanoma Peptide Vaccine)
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.
Other Names:
  • melanoma peptide vaccine
Drug: MDX-010 (anti-CTLA4) monoclonal antibody
3mg/kg (intravenous [iv] infusion over 90 minutes), every 3 weeks for 4 doses
Other Names:
  • ipilimumab
Active Comparator: 3
MDX-010 (ipilimumab) + Placebo
Drug: MDX-010 (anti-CTLA4) monoclonal antibody
3mg/kg (intravenous [iv] infusion over 90 minutes), every 3 weeks for 4 doses
Other Names:
  • ipilimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.
From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
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)
12-, 18-, and 24-Month Survival Rates
Time Frame: Month 12, Month 18, Month 24
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
Progression Free Survival (PFS)
Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
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)
Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24
Time Frame: Week 12, 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
Time to Progression (TTP)
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])
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])
Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD)
Time Frame: BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1.
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.
Determination of Best Overall Response Rate (BORR)
Time Frame: Up to week 24
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
Time to Response
Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
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)
Duration of Response
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])
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])
Disease Control Rate (DCR)
Time Frame: Up to week 24
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
Delayed Response (Response Beyond Week 24)
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])
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])
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
Time Frame: Baseline (Day 1, Cycle1), 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
Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death
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]).
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]).
Percentage of Participants With Immune-Related Adverse Events (irAEs)
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]).
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]).
Percentage of Participants With Worst On-Study Hematological Abnormalities
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]).
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]).
Percentage of Participants With Worst On-Study Liver Abnormalities
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]).
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]).
Percentage of Participants With Worst On-Study Renal Abnormalities
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]).
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]).
Clinically Meaningful Changes in Vital Signs and Physical Examinations
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
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

Collaborators and Investigators

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Sponsor

Bristol-Myers Squibb

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 21, 2004

First Submitted That Met QC Criteria

October 21, 2004

First Posted (Estimate)

October 22, 2004

Study Record Updates

Last Update Posted (Estimate)

July 11, 2011

Last Update Submitted That Met QC Criteria

June 29, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDX010-20
  • CA184-002 (Other Identifier: BMS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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