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

26 febbraio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

32

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Marseille, Francia, 13273
        • Research Site
      • Villejuif, Francia, 94805
        • Research Site
  • Irlanda
      • Dublin 8, Irlanda
        • Research Site
      • Galway, Irlanda
        • Research Site
  • Regno Unito
      • Leicester, Regno Unito, LE1 5WW
        • Research Site
  • Stati Uniti
    • California
      • La Jolla, California, Stati Uniti, 92093
        • Research Site
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87131
        • Research Site
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Research Site
    • Texas
      • Dallas, Texas, Stati Uniti, 75390
        • Research Site
      • Houston, Texas, Stati Uniti, 77030
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: MEDI4736
Droga: MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
Sperimentale: MEDI4736 and tremelimumab
Droga: MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
Droga: tremelimumab
Tremelimumab is an anti-CTLA4 monoclonal antibody (MAb) administered via intravenous infusion
Sperimentale: MEDI4736 and AZD9150
Droga: MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
Droga: AZD9150
AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Number of subjects who develop anti-drug antibodies (ADA)
Lasso di tempo: Screening through 90 days after last dose of study medication
Screening through 90 days after last dose of study medication
Time to Response
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Measured on tumor samples provided at screening
Measured on tumor samples provided at screening

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

MedImmune LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 luglio 2016

Completamento primario (Effettivo)

4 febbraio 2019

Completamento dello studio (Effettivo)

4 febbraio 2019

Date di iscrizione allo studio

Primo inviato

27 agosto 2015

Primo inviato che soddisfa i criteri di controllo qualità

11 settembre 2015

Primo Inserito (Stima)

15 settembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 febbraio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 febbraio 2019

Ultimo verificato

1 febbraio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D4190C00023

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

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Sedi

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