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

28 juin 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

248

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Afrique du Sud
    • Gauteng
      • Johannesburg, Gauteng, Afrique du Sud, 2199
        • Local Institution
    • Western Cape
      • Cape Town, Western Cape, Afrique du Sud, 7570
        • Local Institution
  • Allemagne
      • Berlin, Allemagne, D-12200
        • Local Institution
      • Heidelberg, Allemagne, 69120
        • Local Institution
      • Kiel, Allemagne, D-24105
        • Local Institution
  • Argentine
      • Buenos Aires, Argentine, CP1280AEB
        • Local Institution
  • Belgique
      • Brussels, Belgique, 1090
        • Local Institution
      • Brussels, Belgique, 1070
        • Local Institution
      • Bruxelles, Belgique, 1200
        • Local Institution
  • Brésil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brésil, 90610
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brésil, 90050
        • Local Institution
    • Sao Paulo
      • Jau, Sao Paulo, Brésil, 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
  • Danemark
      • Aarhus C, Danemark, 8000
        • Local Institution
  • Espagne
      • Malaga, Espagne, 29010
        • Local Institution
      • Valencia, Espagne, 46009
        • Local Institution
  • France
      • Brest, France, 29200
        • Local Institution
      • Lyon Cedex 08, France, 69373
        • Local Institution
      • Paris, France, 75010
        • Local Institution
      • Vandoeuvre Les Nancy, France, 54511
        • Local Institution
  • Fédération Russe
      • St. Petersburg, Fédération Russe, 191104
        • Local Institution
      • Stavropol, Fédération Russe, 355047
        • Local Institution
      • Voronezh, Fédération Russe, 394000
        • Local Institution
  • Israël
      • Jerusalem, Israël, 91120
        • Local Institution
      • Tel-Aviv, Israël, 64239
        • Local Institution
  • Italie
      • Genova, Italie, 16132
        • Local Institution
      • Meldola (Fc), Italie, 47014
        • Local Institution
      • Rimini, Italie, 47900
        • Local Institution
      • Siena, Italie, 53100
        • Local Institution
  • L'Autriche
      • Wels, L'Autriche, A-4600
        • Local Institution
      • Wien, L'Autriche, 1090
        • Local Institution
  • Norvège
      • Oslo, Norvège, 0310
        • Local Institution
  • Pologne
      • Lodz, Pologne, 90553
        • Local Institution
      • Poznan, Pologne, 61-866
        • Local Institution
      • Wroclaw, Pologne, 51-124
        • Local Institution
  • République tchèque
      • Olomouc, République tchèque, 775 20
        • Local Institution
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49044
        • Local Institution
  • États-Unis
    • Arizona
      • Tucson, Arizona, États-Unis, 85719
        • University of Arizona Cancer Center
    • California
      • Laverne, California, États-Unis, 91750
        • Wilshire Oncology Medical Group Inc
      • Los Angeles, California, États-Unis, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, États-Unis, 90025
        • The Angeles Clinic & Research Inst.
      • San Francisco, California, États-Unis, 94115
        • San Francisco Oncology Associates
    • Connecticut
      • To come, Connecticut, États-Unis
        • Local Institution
    • Florida
      • Jacksonville, Florida, États-Unis, 32207
        • Baptist Cancer Institute
    • Illinois
      • Chicago, Illinois, États-Unis, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46202
        • Indiana Oncology Hematology Consultants
    • Missouri
      • Saint Louis, Missouri, États-Unis, 63110
        • Washington University School of Medicine
      • St Joseph, Missouri, États-Unis, 64507
        • St Joseph Oncology Inc
    • New York
      • New York, New York, États-Unis, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte, North Carolina, États-Unis, 28203
        • Carolinas Medical Center
    • Ohio
      • Cincinnati, Ohio, États-Unis, 45219
        • The Christ Hospital Cancer Center Research
    • Oregon
      • Portland, Oregon, États-Unis, 97213
        • Providence Portland Medical Center
    • South Carolina
      • Greenville, South Carolina, États-Unis, 29615
        • Cancer Centers of the Carolinas
    • Texas
      • Dallas, Texas, États-Unis, 75230
        • Center For Oncology Research & Treatment, P.A.
      • Lubbock, Texas, États-Unis, 79410
        • Joe Arrington Cancer Research and Treatment Center
    • Washington
      • Seattle, Washington, États-Unis, 98109
        • University Of Washington Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Autres noms:
  • BMS-734016
  • MDX-010
Expérimental: 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.
Médicament: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Autres noms:
  • BMS-734016
  • MDX-010
Expérimental: 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.
Médicament: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Autres noms:
  • BMS-734016
  • MDX-010
Expérimental: 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.
Médicament: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Autres noms:
  • BMS-734016
  • MDX-010
Expérimental: 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.
Médicament: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Autres noms:
  • BMS-734016
  • MDX-010
Expérimental: 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.
Médicament: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Autres noms:
  • BMS-734016
  • MDX-010
Aucune intervention: Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall Survival (OS)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Bristol-Myers Squibb

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2006

Achèvement primaire (Réel)

1 septembre 2012

Achèvement de l'étude (Réel)

1 avril 2014

Dates d'inscription aux études

Première soumission

9 septembre 2005

Première soumission répondant aux critères de contrôle qualité

9 septembre 2005

Première publication (Estimation)

13 septembre 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

27 juillet 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 juin 2016

Dernière vérification

1 juin 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CA184-025

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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