AzTrials
AzTrials

MelanomaPhase 3NCT00094653

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

A Phase 3 study testing MDX-010 (anti-CTLA4) monoclonal antibody and MDX-1379 (gp100) Melanoma Peptide Vaccine in people with Melanoma and Metastases, run by Bristol-Myers Squibb at 209 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma, Metastases
What is being tested?
MDX-010 (anti-CTLA4) monoclonal antibody and MDX-1379 (gp100) Melanoma Peptide Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,783 participants
Where
209 sitesin 13 countries
Study dates
Sep 2004to Oct 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

209 sites in 13 countries.

209 sites in 13 countries

United States110 sites

  • New Mexico Oncology Hematology Consultants, Ltd.

    Albuquerque, New Mexico, 87109

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Emory University Hospital-Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Anschutz Cancer Pavilion

    Aurora, Colorado, 80010

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • University of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Family Cancer Center

    Bartlett, Tennessee, 38133

  • Beth Isreal Dec Medical Center

    Boston, Massachusetts, 02115

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80304

  • Fletcher Allen Health Care

    Burlington, Vermont, 05405

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7050

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Family Cancer Center

    Collierville, Tennessee, 38017

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80909

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • Humphrey Cancer Center

    Coon Rapids, Minnesota, 55433

  • Center for Oncology Research and Treatment

    Dallas, Texas, 75230

  • Henry Ford Medical Center

    Dearborn, Michigan, 48126

  • Cancer Care Specialists of Central IL

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • University of Colorado Hospital

    Denver, Colorado, 80262

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Cancer Centers of the Carolinas

    Easley, South Carolina, 29640

  • Hematology-Oncology Associates of CNY

    East Syracuse, New York, 13057

  • Cancer Care Specialists of Central IL

    Effingham, Illinois, 62401

  • San Diego Cancer Center

    Encinitas, California, 92024

  • Humphrey Cancer Center

    Fridley, Minnesota, 55432

  • Center for Cancer Care at Goshen Health System

    Goshen, Indiana, 46526

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29615

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Memorial Regional Cancer Center

    Hollywood, Florida, 33021

  • Indiana Oncology Hematology Consultants North

    Indianapolis, Indiana, 46202

  • American Health Network of IN, LLC

    Indianapolis, Indiana, 46237

  • Indiana Oncology Hematology South

    Indianapolis, Indiana, 46237

  • Shands Jacksonville

    Jacksonville, Florida, 32209

  • University of Florida/Jacksonville Faculty Clinic

    Jacksonville, Florida, 32209

  • La Jolla Hematology and Oncology Medical Group

    La Jolla, California, 92037

  • Scripps Cancer Center

    La Jolla, California, 92037

  • Moores UCSD Cancer Center

    La Jolla, California, 92093

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Rocky Mountain Cancer Centers

    Littleton, Colorado, 80120

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Rocky Mountain Cancer Centers

    Longmont, Colorado, 80501

  • Cancer Institute Medical Group, Inc

    Los Angeles, California, 90025

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Norton Hospital

    Louisville, Kentucky, 40202

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Lutherville, Maryland, 21093

  • Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.

    Maywood, Illinois, 60153

  • Family Cancer Center

    Memphis, Tennessee, 38119

  • The West Clinic

    Memphis, Tennessee, 38120

  • Jackson Memorial Hospital & Clinics

    Miami, Florida, 33136

  • University of Miami Hospital & Clinics

    Miami, Florida, 33136

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Hematology-Oncology Associates of Northern NJ, PA

    Morristown, New Jersey, 07962

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

  • The Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Yale University School of Medicine - Oncology Outpatient Clinic

    New Haven, Connecticut, 06520

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Columbia University Medical Center, Irving Center for Clinical Research

    New York, New York, 10032

  • Indiana Oncology Hematology Consutants of Noblesville

    Noblesville, Indiana, 46060

  • North County Oncology Medical Clinical, Inc.

    Oceanside, California, 92056

  • Family Cancer Center

    Olive Branch, Mississippi, 38654

  • M.D. Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Palm Beach Cancer Institute

    Palm Beach Gardens, Florida, 33410

  • City of Hope Medical Group

    Pasadena, California, 91105

  • Thomas Jefferson University Hosptital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Hillman Cancer Research Pavilion

    Pittsburgh, Pennsylvania, 15213

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • The Oregon Clinical

    Portland, Oregon, 97213

  • Center for Oncology Research and Treatment

    Richardson, Texas, 75080

  • Hubert H Humphrey Cancer Center

    Robbinsdale, Minnesota, 55422

  • St. Joseph Oncology, Inc

    Saint Joseph, Missouri, 64507

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112-5550

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of California, San Diego

    San Diego, California, 92103

  • St. Mary's Medical Center - Northern California Melanoma Center

    San Francisco, California, 94109

  • Cancer Institute Medical Group, Inc

    Santa Monica, California, 90404

  • Cancer Centers of the Carolinas

    Seneca, South Carolina, 29672

  • Cancer Centers of the Carolinas

    Spartanburg, South Carolina, 29307

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Washington Unv. School of Med./ Siteman Cancer Center

    St Louis, Missouri, 63110

  • Overlook Oncology Center

    Summit, New Jersey, 07901

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • University Medical Center

    Tucson, Arizona, 85724

  • San Diego Cancer Center

    Vista, California, 92081

  • Palm Beach Cancer Institute

    Wellington, Florida, 33414

  • Henry Ford Medical Center- West Bloomfield

    West Bloomfield, Michigan, 48322

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

Other trials in United States

Brazil17 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, São Paulo

  • Hospital de Cancer de Barretos - Fundacao Pio XII

    Barretos - SP, 14784-400

  • Biocor - Hosp. de Doencas Cardiovasculares Ltda.

    Belo Horizonte - MG, 34000-000

  • Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias

    Goiânia, Goiás

  • Hospital Araujo Jorge

    Goiania - GO, 74605-070

  • Fundacoa Hospital Amaral Carvalho

    Jaú, São Paulo

  • Pro Onco Centro Tratamento Oncologico

    Londrina, Paraná

  • Pro Onco Centro Tratemento Oncologico

    Londrina - PR, 86050-190

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul

  • Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD

    Porto Alegre, 90035-003

  • Fund. SOAD / HC de Porto Alegre

    Porto Alegre - RS, 90035-003

  • Hospital Sao Lucas - PUCRS

    Porto Alegre - RS, 90610-000

  • Santo Andre Diagnosticos aTratamentos

    Santo André, São Paulo

  • Santo Andre Diagnosticos e Tratamentos Ltda.

    Santo Andre-SP, 09090-780

  • Sociedade Beneficante de Sennores - Hospital Sino Libante

    São Paulo, São Paulo

  • HC-FMUSP

    Sao Paulo - SP, 05403-000

  • Hospital Sirio Labanes

    Sao Paulo-SP, 01308-050

Other trials in Brazil

Argentina14 sites

  • Hospital Militar Central

    Buenos Aires

  • Instituto Medico Especializado Alexander Fleming

    Buenos Aires

  • Hospital Municipal de Oncoligia Maria Curie

    Ciudad de Buenos Aires, Buenos Aires

  • Hospital Britanico de Buenos Aires

    Ciudad de Buenos Aires, C1280AEB

  • Hospital Municipal de Oncologia Maria Curie

    Ciudad de Buenos Aires, C1405BWU

  • Hospital General de Agudos Carlos G. Durand

    Ciudad de Buenos Aires, C1405DCS

  • Instituto de Oncologia Angel H. Roffo

    Ciudad de Buenos Aires, C1417DTB

  • Hospital Militar Central

    Ciudad de Buenos Aires, C1426BOS

  • Instituto Alexander Fleming

    Ciudad de Buenos Aires, C1426DRB

  • Hospital Privado de Cordoba S.A.

    Córdoba, X5016KEH

  • Hospital Privado Centro Medico de Cordoba S.A.

    Córdoba

  • Instituto Medico Platense

    La Plata, Buenos Aires, 1900

  • ISIS Clinica Especializada

    Santa Fe, Santa Fe Province

  • ISIS Clinica Especializada

    Santa Fe, S3000FFU

Other trials in Argentina

Germany14 sites

  • Klinikum Augsburg

    Augsburg, 86156

  • Charite Universitaets medizin Berlin

    Berlin, 10117

  • Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin

    Berlin, 12200

  • Universitaetsklinikum Dusseldorf

    Düsseldorf, 40225

  • Universitaetsklinikum Erlangen

    Erlangen, 91052

  • Universitaetsklinikum Essen

    Essen, 45122

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69115

  • Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie

    Hufelandstr. 55, Hesse, 45122

  • Klinikum der Friedrich-Schiller-Universitaet Jena

    Jena, 07740

  • Klinikum Mannheim gGmbH

    Mannheim, 68167

  • University of Mannheim

    Mannheim

  • Klinikum Rechts der Isar / TU Muenchen

    München, 81675

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

France11 sites

  • Centre Oscar Lambret

    Lille, 59020 Cedex

  • Centre Leon Berard

    Lyon, 69373 Cedex 08

  • Hopital Sainte-Marguerite

    Marseille, 13009

  • Hopital Saint-Eloi

    Montpellier, 34295 Cedex 5

  • Hotel Dieu

    Nantes, 44093 Cedex 1

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital Saint-Louis

    Paris, 75010 10

  • Centre Eugene Marquis

    Rennes, 35042 Cedex

  • Centre-Hospitalier Universitaire de Saint-Etienne

    Saint-Etienne, 42055 Cedex 2

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511 Cedex

  • Institut Gustave Roussy (IGR)

    Villejuif, 94805 Cedex

Other trials in France

Canada9 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Cancer Centre of Southeastern Ontario at KGH

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Sir Mortimer B. Davis - Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • The Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United Kingdom9 sites

  • Velindre Hospital

    Cardiff, CF14 2TL

  • Ninewells Hospital

    Dundee, DD1 9SY

  • St. Luke's Cancer Center, The Royal Surrey County Hospital

    Guildford, Surry, GU2 7XX

  • Christie Hospital

    Manchester, M20 4BX

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Poole Hospital

    Poole, BH15 2JB

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • Southampton General

    Southampton, SO16 6YD

Other trials in United Kingdom

Belgium6 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Erasme Hospital, Free Universtiy of Brussels

    Brussels, 1070

  • Erasme Hospital

    Brussels, 1070

  • U.Z. Gent

    Ghent, 9000

  • Universitair Ziekenhuis Gasthuisberg

    Leuven, 3000

  • Cliniques Universitaires UCL de Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Chile5 sites

  • Instituto Nacional del Cancer

    Independencia, Santiago Metropolitan

  • Clinica Davila

    Recoleta, Santiago Metropolitan

  • Clinica Renaca

    Reñaca, Vina Del Mar

  • Fundacion Arturo Lopez Perez

    Santiago, Santiago Metropolitan

  • Hospital Barros Luco

    Santiago, Santiago Metropolitan

Other trials in Chile

Hungary4 sites

  • National Institute of Oncology

    Budapest, H-1122

  • University of Debrecen, Medical and Health Sciences Center

    Debrecen, H-4012

  • Semmelweis Hospital

    Miskolc, H-3529

  • University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center

    Szeged, H-6720

Other trials in Hungary

South Africa4 sites

  • Mary Potter Oncology Centre

    Groenkloof, 0181

  • GVI Oncology

    Panorama, 7500

  • Mary Potter Oncology Centre

    Pretoria, 0181

  • Sandton Onocology Medical Research

    Sandton, 2199

Other trials in South Africa

Netherlands3 sites

  • Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX

  • Vrije Universiteit Medisch Centrum (VUMC)

    Amsterdam, 1081 HV

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6229 HX

Other trials in Netherlands

Switzerland3 sites

  • Centre Hospitalier Universitaire Vaudois - CHUV

    Lausanne, Rue Du Bugnon 46, CH-1011

  • Centre Hospitalier Universitaire Vaudois - CHUV

    Lausanne, CH-1011

  • Dermatologische Klinik Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Read the 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.

Conditions
Melanoma, Metastases
Being tested
MDX-010 (anti-CTLA4) monoclonal antibody, MDX-1379 (gp100) Melanoma Peptide Vaccine
Keywords
melanoma, metastatic melanoma, skin cancer
Medical subject headings
Melanoma, Neoplasm Metastasis, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDX-010 (anti-CTLA4) monoclonal antibodyDrug

    Also called ipilimumab

    3mg/kg (intravenous [iv] infusion over 90 minutes), every 3 weeks for 4 doses

  • MDX-1379 (gp100) Melanoma Peptide VaccineBiological

    Also called melanoma peptide vaccine

    2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.

Study groups in NCT00094653
Study groupRoleWhat they receive
1Active comparatorMelanoma Peptide Vaccine (MDX-1379) (gp100) + Placebo
Receives: Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine
2ExperimentalMDX-010 (ipilimumab) + MDX-1379 (gp100) (Melanoma Peptide Vaccine)
Receives: Drug: MDX-010 (anti-CTLA4) monoclonal antibody; Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine
3Active comparatorMDX-010 (ipilimumab) + Placebo
Receives: Drug: MDX-010 (anti-CTLA4) monoclonal antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone

    OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.

    Measured: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)

Secondary outcomes (18)

  1. 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.

    Measured: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)

  2. 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.

    Measured: Month 12, Month 18, Month 24

  3. 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.

    Measured: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)

  4. 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.

    Measured: Week 12, Week 24

  5. 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.

    Measured: 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])

  6. 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.

    Measured: BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1.

  7. 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.

    Measured: Up to week 24

  8. 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.

    Measured: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)

  9. 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).

    Measured: 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])

  10. 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.

    Measured: Up to week 24

  11. 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.

    Measured: 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])

  12. 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).

    Measured: Baseline (Day 1, Cycle1), Week 12

  13. 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.

    Measured: 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]).

  14. 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.

    Measured: 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]).

  15. 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.

    Measured: 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]).

  16. 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.

    Measured: 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]).

  17. 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.

    Measured: 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]).

  18. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2004 (estimated)
  2. Study startSep 2004
  3. Primary completionAug 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,783 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00094653
Sponsor's protocol ID
MDX010-20
Other IDs
CA184-002
Status last verified
Jun 2011
First submitted
21 Oct 2004
Last updated
11 Jul 2011
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26700304

  • 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.

    PubMed 26627641

  • 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.

    PubMed 25667295

  • 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.

    PubMed 25649350

  • 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.

    PubMed 25214238

  • 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.

    PubMed 23942774

  • 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.

    PubMed 23444228

  • 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.

    PubMed 23400564

  • 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.

    PubMed 22694829

  • 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.

    PubMed 20525992

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MDX-010 (anti-CTLA4) monoclonal antibody and MDX-1379 (gp100) Melanoma Peptide Vaccine in people with Melanoma and Metastases, run by Bristol-Myers Squibb at 209 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 209 sites in United States, Brazil, Argentina, Germany, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (time frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00094653, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2011.

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