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

26 februari 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

32

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Marseille, Frankrike, 13273
        • Research Site
      • Villejuif, Frankrike, 94805
        • Research Site
  • Förenta staterna
    • California
      • La Jolla, California, Förenta staterna, 92093
        • Research Site
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21201
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Förenta staterna, 87131
        • Research Site
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
        • Research Site
    • Texas
      • Dallas, Texas, Förenta staterna, 75390
        • Research Site
      • Houston, Texas, Förenta staterna, 77030
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, Förenta staterna, 53226
        • Research Site
  • Irland
      • Dublin 8, Irland
        • Research Site
      • Galway, Irland
        • Research Site
  • Storbritannien
      • Leicester, Storbritannien, LE1 5WW
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: MEDI4736
Läkemedel: MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
Experimentell: MEDI4736 and tremelimumab
Läkemedel: MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
Läkemedel: tremelimumab
Tremelimumab is an anti-CTLA4 monoclonal antibody (MAb) administered via intravenous infusion
Experimentell: MEDI4736 and AZD9150
Läkemedel: MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
Läkemedel: AZD9150
AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

MedImmune LLC

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

13 juli 2016

Primärt slutförande (Faktisk)

4 februari 2019

Avslutad studie (Faktisk)

4 februari 2019

Studieregistreringsdatum

Först inskickad

27 augusti 2015

Först inskickad som uppfyllde QC-kriterierna

11 september 2015

Första postat (Uppskatta)

15 september 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 februari 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 februari 2019

Senast verifierad

1 februari 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D4190C00023

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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