MEDI4736 Alone and in Combination With Tremelimumab or AZD9150 in Adult Subjects With Relapsed/Refractory DLBCL (D4190C00023)
2019年2月26日 更新者: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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
32
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Dublin 8、アイルランド
- Research Site
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Galway、アイルランド
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California
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La Jolla、California、アメリカ、92093
- Research Site
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Maryland
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Baltimore、Maryland、アメリカ、21201
- Research Site
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New Mexico
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Albuquerque、New Mexico、アメリカ、87131
- Research Site
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North Carolina
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Durham、North Carolina、アメリカ、27710
- Research Site
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Research Site
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Texas
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Dallas、Texas、アメリカ、75390
- Research Site
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Houston、Texas、アメリカ、77030
- Research Site
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53226
- Research Site
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Leicester、イギリス、LE1 5WW
- Research Site
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Marseille、フランス、13273
- Research Site
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Villejuif、フランス、94805
- Research Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age ≥ 18 years
- 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
- Eastern Cooperative Group (ECOG) performance status of 0 or 1
- Measurable disease by International Working Group (IWG) response criteria for lymphoma
- Adequate organ and marrow function
Exclusion Criteria:
- Previous immune-mediated therapy
- 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.
- 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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:MEDI4736
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MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
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実験的:MEDI4736 and tremelimumab
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MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
Tremelimumab is an anti-CTLA4 monoclonal antibody (MAb) administered via intravenous infusion
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実験的:MEDI4736 and AZD9150
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MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Number of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events
時間枠:Screening through 90 days after the last dose of study medication
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Screening through 90 days after the last dose of study medication
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Number of subjects experiencing dose-limiting toxicities
時間枠: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
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Changes from baseline in laboratory parameters, vital signs, and ECGs
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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
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二次結果の測定
結果測定 |
時間枠 |
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Number of subjects who develop anti-drug antibodies (ADA)
時間枠:Screening through 90 days after last dose of study medication
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Screening through 90 days after last dose of study medication
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Time to Response
時間枠:Screening though 3 years after the last subject receives the first dose of study medication
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Screening though 3 years after the last subject receives the first dose of study medication
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Duration of Response
時間枠:Screening though 3 years after the last subject receives the first dose of study medication
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Screening though 3 years after the last subject receives the first dose of study medication
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Progression Free survival
時間枠:Screening though 3 years after the last subject receives the first dose of study medication
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Screening though 3 years after the last subject receives the first dose of study medication
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Time to progression
時間枠:Screening though 3 years after the last subject receives the first dose of study medication
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Screening though 3 years after the last subject receives the first dose of study medication
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Event free survival
時間枠:Screening though 3 years after the last subject receives the first dose of study medication
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Screening though 3 years after the last subject receives the first dose of study medication
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Overall survival
時間枠:Screening though 3 years after the last subject receives the first dose of study medication
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Screening though 3 years after the last subject receives the first dose of study medication
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MEDI4736 Maximum Plasma Concentration (Cmax)
時間枠:Measured at defined study visits from time of first dose through end of treatment
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Measured at defined study visits from time of first dose through end of treatment
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Tremelimumab Maximum Plasma Concentration (Cmax)
時間枠:Measured at defined study visits from time of first dose through end of treatment
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Measured at defined study visits from time of first dose through end of treatment
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AZD9150 Maximum Plasma Concentration (Cmax)
時間枠:Measured at defined study visits from time of first dose through end of treatment
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Measured at defined study visits from time of first dose through end of treatment
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MEDI4736 Minimum Plasma Concentration (Cmin)
時間枠:Measured at defined study visits from time of first dose through end of treatment
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Measured at defined study visits from time of first dose through end of treatment
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Tremelimumab Minimum Plasma Concentration (Cmin)
時間枠:Measured at defined study visits from time of first dose through end of treatment
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Measured at defined study visits from time of first dose through end of treatment
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AZD9150 Minimum Plasma Concentration (Cmin)
時間枠:Measured at defined study visits from time of first dose through end of treatment
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Measured at defined study visits from time of first dose through end of treatment
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Individual MEDI4736 Concentrations
時間枠:Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
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Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
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Individual tremelimumab Concentrations
時間枠:Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
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Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
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Individual AZD9150 Concentrations
時間枠:Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
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Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
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Change from baseline of STAT3 RNA (signal transducer and activator of transcription)
時間枠:Measured at defined study visits from time of first dose through 90 days after last dose (approximately 15 months)
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Measured at defined study visits from time of first dose through 90 days after last dose (approximately 15 months)
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Baseline PD-L1 protein expression within the tumor
時間枠:Measured on tumor samples provided at screening
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Measured on tumor samples provided at screening
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年7月13日
一次修了 (実際)
2019年2月4日
研究の完了 (実際)
2019年2月4日
試験登録日
最初に提出
2015年8月27日
QC基準を満たした最初の提出物
2015年9月11日
最初の投稿 (見積もり)
2015年9月15日
学習記録の更新
投稿された最後の更新 (実際)
2019年2月27日
QC基準を満たした最後の更新が送信されました
2019年2月26日
最終確認日
2019年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
MEDI4736の臨床試験
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MedImmune LLC完了胃または胃食道接合部腺癌カナダ, アメリカ, 台湾, 大韓民国, 日本, シンガポール
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Italian Network for Tumor Biotherapy FoundationAstraZenecaわからない
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AstraZeneca完了
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)募集ステージ III 肝細胞がん AJCC v8 | ステージ IIIA 肝細胞がん AJCC v8 | IB 期の肝細胞がん AJCC v8 | ステージ II 肝細胞がん AJCC v8アメリカ
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Northwestern UniversityNational Cancer Institute (NCI); Celgene; The Leukemia and Lymphoma Society引きこもった
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University of WashingtonNational Cancer Institute (NCI)引きこもった
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Jena University Hospital募集
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Mayo ClinicNational Cancer Institute (NCI)募集プラチナ耐性肺小細胞がん | プラチナ感受性肺小細胞がん | 再発広汎期肺小細胞がん | 難治性広汎期肺小細胞癌アメリカ
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI); AstraZeneca積極的、募集していないステージ IVA 肺がん AJCC v8 | ステージ IVB 肺がん AJCC v8 | 難治性膵臓癌 | ステージ II 膵臓がん AJCC v8 | ステージ III 膵臓がん AJCC v8 | ステージ IV 膵臓がん AJCC v8 | 肺非小細胞がん | ステージ III 肺がん AJCC v8 | ステージ IV 肺がん AJCC v8 | ステージ IIIA 肺がん AJCC v8 | ステージ IIIB 肺がん AJCC v8 | ステージ IV の結腸直腸がん AJCC v8 | ステージ IVA の結腸直腸がん AJCC v8 | ステージ IVB 結腸直腸がん AJCC v8 | IVC 期の結腸直腸がん AJCC v8 | ステージ... およびその他の条件アメリカ
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Alain AlgaziAstraZeneca; Incyte Corporation引きこもった再発上咽頭がん | 転移性上咽頭がん | IV期の上咽頭がん | エプスタインバーウイルス陽性 | III期の上咽頭がん | IVA期上咽頭がん | IVB期上咽頭がん