A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC
2019年8月6日 更新者：CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001 (Anti-PD-1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel as First-line Therapy for Patients With Primarily Diagnose or Recurrent and Metastatic Triple-Negative Breast Cancer
This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage IV and recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).
調査の概要
研究の種類
介入
入学 (予想される)
375
段階
- フェーズ 3
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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Beijing、中国
- The Fifth Medical Center of PLA General Hospital
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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～70年 (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
女性
説明
Inclusion Criteria:
- Primarily diagnosed stage IV or recurrent and metastatic, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression;
- No prior chemotherapy or targeted systemic therapy for inoperable stage IV or metastatic TNBC；
- Eligible for taxane monotherapy；
- Eastern Cooperative Oncology Group performance status of 0 or 1；
- Measurable disease as defined by RECIST v1.1；
- Adequate hematologic and end-organ function。
Exclusion Criteria:
- Known central nervous system (CNS) disease with active syndrome or untreated disease, except for treated asymptomatic CNS metastases；
- History of autoimmune disease；
- History of Anaphylaxis to PD-(L)1 antibody or CTLA-4 antibody or paclitaxel;
- Prior allogeneic stem cell or solid organ transplantation;
- Active hepatitis B or hepatitis C;
- Positive of HIV antibody.
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：ダブル
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：JS001 Plus Nab-Paclitaxel
Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
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JS001 at a fixed dose of 240 milligrams via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
他の名前：
Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle.
Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.
他の名前：
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プラセボコンパレーター：Placebo Plus Nab-Paclitaxel
Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
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Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle.
Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.
他の名前：
Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
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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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Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)
時間枠：From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)
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PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first.
PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
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From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator
時間枠：From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first.
PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
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From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
時間枠：From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.
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From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
時間枠：From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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DoR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first.
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From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
時間枠：From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.
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From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
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Overall Survival (OS)
時間枠：From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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OS is defined as the time from randomization to death from any cause.
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From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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OS rate at 12 months
時間枠：the percent of participants that are alive at 12months from Day 1.
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OS is defined as the time from randomization to death from any cause.
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the percent of participants that are alive at 12months from Day 1.
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OS rate at 24 months
時間枠：the percent of participants that are alive at 24 months from Day 1.
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OS is defined as the time from randomization to death from any cause.
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the percent of participants that are alive at 24 months from Day 1.
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PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
時間枠：From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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Progression is confirmed in the target lesion category if the next imaging assessment after iUPD (4-8 weeks later) confirms a further increase in sum of measures of target disease from iUPD, with an increase of at least 5mm.
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From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
時間枠：From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria.
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From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
時間枠：From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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DoR is defined as the time period from the date of initial iCR or iPR until the date of iCPD or death from any cause, whichever occurs first.
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From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
時間枠：From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST.
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From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
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Percentage and severity of Participants With Adverse Events (AEs)
時間枠：From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)
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percentage and CTC AE(v5.0) of AEs
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From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)
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Percentage of Participants With Anti-Drug Antibodies (ATAs)
時間枠：Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days)
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Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days)
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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。
捜査官
- 主任研究者：JIANG ZE FEI, PHD、Beijing 302 Hospital
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)
2018年12月21日
一次修了 (予想される)
2019年12月30日
研究の完了 (予想される)
2020年7月30日
試験登録日
最初に提出
2018年12月12日
QC基準を満たした最初の提出物
2018年12月13日
最初の投稿 (実際)
2018年12月17日
学習記録の更新
投稿された最後の更新 (実際)
2019年8月8日
QC基準を満たした最後の更新が送信されました
2019年8月6日
最終確認日
2018年12月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NABP201801
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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。