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A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

28. juni 2016 opdateret af: Bristol-Myers Squibb

A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.

The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

248

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, CP1280AEB
        • Local Institution
  • Belgien
      • Brussels, Belgien, 1090
        • Local Institution
      • Brussels, Belgien, 1070
        • Local Institution
      • Bruxelles, Belgien, 1200
        • Local Institution
  • Brasilien
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brasilien, 90610
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brasilien, 90050
        • Local Institution
    • Sao Paulo
      • Jau, Sao Paulo, Brasilien, 17210
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Local Institution
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Local Institution
  • Danmark
      • Aarhus C, Danmark, 8000
        • Local Institution
  • Den Russiske Føderation
      • St. Petersburg, Den Russiske Føderation, 191104
        • Local Institution
      • Stavropol, Den Russiske Føderation, 355047
        • Local Institution
      • Voronezh, Den Russiske Føderation, 394000
        • Local Institution
  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85719
        • University of Arizona Cancer Center
    • California
      • Laverne, California, Forenede Stater, 91750
        • Wilshire Oncology Medical Group Inc
      • Los Angeles, California, Forenede Stater, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, Forenede Stater, 90025
        • The Angeles Clinic & Research Inst.
      • San Francisco, California, Forenede Stater, 94115
        • San Francisco Oncology Associates
    • Connecticut
      • To come, Connecticut, Forenede Stater
        • Local Institution
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32207
        • Baptist Cancer Institute
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana Oncology Hematology Consultants
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • St Joseph, Missouri, Forenede Stater, 64507
        • St Joseph Oncology Inc
    • New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Carolinas Medical Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • The Christ Hospital Cancer Center Research
    • Oregon
      • Portland, Oregon, Forenede Stater, 97213
        • Providence Portland Medical Center
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29615
        • Cancer Centers of the Carolinas
    • Texas
      • Dallas, Texas, Forenede Stater, 75230
        • Center For Oncology Research & Treatment, P.A.
      • Lubbock, Texas, Forenede Stater, 79410
        • Joe Arrington Cancer Research and Treatment Center
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • University of Washington Medical Center
  • Frankrig
      • Brest, Frankrig, 29200
        • Local Institution
      • Lyon Cedex 08, Frankrig, 69373
        • Local Institution
      • Paris, Frankrig, 75010
        • Local Institution
      • Vandoeuvre Les Nancy, Frankrig, 54511
        • Local Institution
  • Israel
      • Jerusalem, Israel, 91120
        • Local Institution
      • Tel-Aviv, Israel, 64239
        • Local Institution
  • Italien
      • Genova, Italien, 16132
        • Local Institution
      • Meldola (Fc), Italien, 47014
        • Local Institution
      • Rimini, Italien, 47900
        • Local Institution
      • Siena, Italien, 53100
        • Local Institution
  • Norge
      • Oslo, Norge, 0310
        • Local Institution
  • Polen
      • Lodz, Polen, 90553
        • Local Institution
      • Poznan, Polen, 61-866
        • Local Institution
      • Wroclaw, Polen, 51-124
        • Local Institution
  • Spanien
      • Malaga, Spanien, 29010
        • Local Institution
      • Valencia, Spanien, 46009
        • Local Institution
  • Sydafrika
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika, 2199
        • Local Institution
    • Western Cape
      • Cape Town, Western Cape, Sydafrika, 7570
        • Local Institution
  • Tjekkiet
      • Olomouc, Tjekkiet, 775 20
        • Local Institution
  • Tyskland
      • Berlin, Tyskland, D-12200
        • Local Institution
      • Heidelberg, Tyskland, 69120
        • Local Institution
      • Kiel, Tyskland, D-24105
        • Local Institution
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49044
        • Local Institution
  • Østrig
      • Wels, Østrig, A-4600
        • Local Institution
      • Wien, Østrig, 1090
        • Local Institution

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria

  • Diagnosis of advanced melanoma
  • Prior treatment in a prespecified prior/parent ipilimumab study
  • Men and women 18 years of age and older

First Reinduction:

  • No unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation
  • Had experienced documented progressive disease after expanded clinical benefit

Extended Maintenance

  • Received ipilimumab at any dose in a parent study
  • Achieved expanded clinical benefit at the time of entry to current study

Follow-up:

  • Received ipilimumab at any dose in a closing parent study
  • Deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up

Key Exclusion Criteria

  • Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab
  • Primary ocular or mucosal melanoma

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: First reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Medicin: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Andre navne:
  • BMS-734016
  • MDX-010
Eksperimentel: First reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Medicin: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Andre navne:
  • BMS-734016
  • MDX-010
Eksperimentel: First reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Medicin: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Andre navne:
  • BMS-734016
  • MDX-010
Eksperimentel: Extended maintenance: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Medicin: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Andre navne:
  • BMS-734016
  • MDX-010
Eksperimentel: Extended maintenance: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Medicin: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Andre navne:
  • BMS-734016
  • MDX-010
Eksperimentel: Extended maintenance: Ipilimumab, 10 mg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Medicin: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Andre navne:
  • BMS-734016
  • MDX-010
Ingen indgriben: Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
Tidsramme: Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: From first dose of study drug in parent study to death or date of last censoring.
OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.
From first dose of study drug in parent study to death or date of last censoring.
Percentage of Participants Surviving at 1, 1.5, and 2 Years
Tidsramme: From first dose of study drug in parent study to up to 2 years after reinduction
Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.
From first dose of study drug in parent study to up to 2 years after reinduction
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Tidsramme: From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date
irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.
From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date
Progression-free Survival (PFS)
Tidsramme: From day of first reinduction in current study to date of progression or death, whichever occurred first.
PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.
From day of first reinduction in current study to date of progression or death, whichever occurred first.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2006

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. april 2014

Datoer for studieregistrering

Først indsendt

9. september 2005

Først indsendt, der opfyldte QC-kriterier

9. september 2005

Først opslået (Skøn)

13. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CA184-025

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Melanom

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