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MEDI4736 Alone and in Combination With Tremelimumab or AZD9150 in Adult Subjects With Relapsed/Refractory DLBCL (D4190C00023)

26 février 2019 mis à jour par: MedImmune LLC

A Phase 1b Study to Evaluate the Safety and Efficacy of MEDI4736 as Monotherapy and in Combination With Tremelimumab or AZD9150 in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma.

The purpose of this study is to evaluate the safety, tolerability, and efficacy of MEDI4736 (durvalumab) alone and in combination with either tremelimumab or AZD9150 in adult subjects with relapsed or refractory dIffuse large B-cell lymphoma.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This is a multicenter, open-label, dose-escalation and dose-expansion study of MEDI4736 (durvalumab) as monotherapy or in combination with either tremelimumab or AZD9150. The objectives are to describe any dose-limiting toxicities, determine the maximum tolerated dose, and evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of MEDI4736 as monotherapy or in combination with either tremelimumab or AZD9150 in adult subjects with relapsed or refractory diffuse large B-cell lymphoma.

Type d'étude

Interventionnel

Inscription (Réel)

32

Phase

  • La phase 1

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

  • France
      • Marseille, France, 13273
        • Research Site
      • Villejuif, France, 94805
        • Research Site
  • Irlande
      • Dublin 8, Irlande
        • Research Site
      • Galway, Irlande
        • Research Site
  • Royaume-Uni
      • Leicester, Royaume-Uni, LE1 5WW
        • Research Site
  • États-Unis
    • California
      • La Jolla, California, États-Unis, 92093
        • Research Site
    • Maryland
      • Baltimore, Maryland, États-Unis, 21201
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87131
        • Research Site
    • North Carolina
      • Durham, North Carolina, États-Unis, 27710
        • Research Site
    • South Carolina
      • Charleston, South Carolina, États-Unis, 29425
        • Research Site
    • Texas
      • Dallas, Texas, États-Unis, 75390
        • Research Site
      • Houston, Texas, États-Unis, 77030
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, États-Unis, 53226
        • Research Site

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

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Subjects with histologically confirmed relapsed or refractory DLBCL who have received at least 1 prior rituximab containing chemotherapy regimen but no more than 5 prior lines of therapy
  3. Eastern Cooperative Group (ECOG) performance status of 0 or 1
  4. Measurable disease by International Working Group (IWG) response criteria for lymphoma
  5. Adequate organ and marrow function

Exclusion Criteria:

  1. Previous immune-mediated therapy
  2. Subjects with prior ASCT or allogenic HCT. Subjects ineligible for available curative options after failing ASCT and have met the hematologic criteria are eligible to participate in this study. Subjects with prior allogenic HCT will be excluded.
  3. Documented current central nervous system involvement

3. Active or prior documented autoimmune or inflammatory disease within 3 years, with some exceptions 4. Concurrent or prior conventional or investigational anticancer therapy, within 28 days prior to the first dose of study medication(s)

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: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: MEDI4736
Médicament: MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
Expérimental: MEDI4736 and tremelimumab
Médicament: MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
Médicament: tremelimumab
Tremelimumab is an anti-CTLA4 monoclonal antibody (MAb) administered via intravenous infusion
Expérimental: MEDI4736 and AZD9150
Médicament: MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
Médicament: AZD9150
AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events
Délai: Screening through 90 days after the last dose of study medication
Screening through 90 days after the last dose of study medication
Number of subjects experiencing dose-limiting toxicities
Délai: First dose of study medications through 28 days after the administration of MEDI4736 or MEDI4736 and tremelimumab, 35 days after administration of MEDI4736 and AZD9150
Changes from baseline in laboratory parameters, vital signs, and ECGs
First dose of study medications through 28 days after the administration of MEDI4736 or MEDI4736 and tremelimumab, 35 days after administration of MEDI4736 and AZD9150

Mesures de résultats secondaires

Mesure des résultats
Délai
Number of subjects who develop anti-drug antibodies (ADA)
Délai: Screening through 90 days after last dose of study medication
Screening through 90 days after last dose of study medication
Time to Response
Délai: Screening though 3 years after the last subject receives the first dose of study medication
Screening though 3 years after the last subject receives the first dose of study medication
Duration of Response
Délai: Screening though 3 years after the last subject receives the first dose of study medication
Screening though 3 years after the last subject receives the first dose of study medication
Progression Free survival
Délai: Screening though 3 years after the last subject receives the first dose of study medication
Screening though 3 years after the last subject receives the first dose of study medication
Time to progression
Délai: Screening though 3 years after the last subject receives the first dose of study medication
Screening though 3 years after the last subject receives the first dose of study medication
Event free survival
Délai: Screening though 3 years after the last subject receives the first dose of study medication
Screening though 3 years after the last subject receives the first dose of study medication
Overall survival
Délai: Screening though 3 years after the last subject receives the first dose of study medication
Screening though 3 years after the last subject receives the first dose of study medication
MEDI4736 Maximum Plasma Concentration (Cmax)
Délai: Measured at defined study visits from time of first dose through end of treatment
Measured at defined study visits from time of first dose through end of treatment
Tremelimumab Maximum Plasma Concentration (Cmax)
Délai: Measured at defined study visits from time of first dose through end of treatment
Measured at defined study visits from time of first dose through end of treatment
AZD9150 Maximum Plasma Concentration (Cmax)
Délai: Measured at defined study visits from time of first dose through end of treatment
Measured at defined study visits from time of first dose through end of treatment
MEDI4736 Minimum Plasma Concentration (Cmin)
Délai: Measured at defined study visits from time of first dose through end of treatment
Measured at defined study visits from time of first dose through end of treatment
Tremelimumab Minimum Plasma Concentration (Cmin)
Délai: Measured at defined study visits from time of first dose through end of treatment
Measured at defined study visits from time of first dose through end of treatment
AZD9150 Minimum Plasma Concentration (Cmin)
Délai: Measured at defined study visits from time of first dose through end of treatment
Measured at defined study visits from time of first dose through end of treatment
Individual MEDI4736 Concentrations
Délai: Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Individual tremelimumab Concentrations
Délai: Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Individual AZD9150 Concentrations
Délai: Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Change from baseline of STAT3 RNA (signal transducer and activator of transcription)
Délai: Measured at defined study visits from time of first dose through 90 days after last dose (approximately 15 months)
Measured at defined study visits from time of first dose through 90 days after last dose (approximately 15 months)
Baseline PD-L1 protein expression within the tumor
Délai: Measured on tumor samples provided at screening
Measured on tumor samples provided at screening

Collaborateurs et enquêteurs

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

Parrainer

MedImmune LLC

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 (Réel)

13 juillet 2016

Achèvement primaire (Réel)

4 février 2019

Achèvement de l'étude (Réel)

4 février 2019

Dates d'inscription aux études

Première soumission

27 août 2015

Première soumission répondant aux critères de contrôle qualité

11 septembre 2015

Première publication (Estimation)

15 septembre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 février 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 février 2019

Dernière vérification

1 février 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • D4190C00023

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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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