非小細胞肺癌（NSCLC）または肝細胞癌（HCC）に対するネオアジュバント ニボルマブと CCR2/5 阻害剤または抗 IL-8）
Tisch Cancer Institute - BMS 研究 # CA027-005: NSCLC または HCC に対するネオアジュバント ニボルマブ + BMS-813160 (CCR2/5 阻害剤) または BMS-986253 (抗 IL-8)
The purpose of this research study is to study the effect of giving nivolumab with CCR2/5-inhibitor or anti-IL-8 before surgery, and after surgery, with the goal of determining if this medicine results in:
- A significant immune response against their tumor (which the study team will see in the tumor that is taken out at the time of surgery)
- Improvement in long term survival rates
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Objectives:
Cohorts A,B (NSCLC):
Primary Objective: Major Pathologic Response (MPR) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response
Cohorts C,D,E (HCC):
Primary Objective: Significant tumor necrosis (STN) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response
Diagnosis and Main Inclusion Criteria:
Patients must have disease deemed resectable before enrollment.
Study Product:
Nivolumab 480mg (q4w, dosed twice before surgery and three times following recovery from surgery) BMS-813160 (CCR2/5-inhibitor) 300mg oral twice a day for 28 days BMS-986253 (anti-IL-8) 2400mg once
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ2
連絡先と場所
研究場所
-
-
New York
-
New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Diagnosis of NSCLC or HCC
- Willing to provide blood samples
- Willing to undergo leukapheresis at Mount Sinai Hospital or New York Blood Bank
- Willing to have excisional or core needle biopsies
- At least 18 years of age
- ECOG 0-1
- Surgical candidate for resection of their tumor
- Agree to use adequate contraception
- Adequate organ and marrow function
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 months for a different primary tumor or patients who have received locoregional therapy for the target lesion
- Patients receiving any other investigational agents
- Patients with metastatic disease for whom the intent of surgery would not be curative
- Uncontrolled intercurrent illness
- Pregnant or nursing
- Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days
- Has active autoimmune disease that has required systemic treatment in the past year
- Has a known additional malignancy that is progressing and/or requires active treatment
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not the in the best interest of the patient to participate
- HIV positive with detectable viral load or anyone not on stable anti-viral regimen
- Has known active Hepatitis B
- History of allogeneic hematopoietic cell transplantation or solid organ transplantation
- Documented allergic or hypersensitivity response to any protein therapeutics
- Patients may not have prolonged QRS or QTc
研究計画
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）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Cohort A
NSCLC: Nivolumab + BMS-813160 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 300mg oral twice a day for 28 days
他の名前：
|
|
実験的：Cohort B
NSCLC: Nivolumab + BMS-986253 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 2400mg once by injection
他の名前：
|
|
実験的：Cohort C
HCC: Nivolumab |
q4w, dosed twice before surgery and three times following recovery from surgery by injection |
|
実験的：Cohort D
HCC: Nivolumab + BMS-813160 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 300mg oral twice a day for 28 days
他の名前：
|
|
実験的：Cohort E
HCC: Nivolumab + BMS-986253 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 2400mg once by injection
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Major Pathologic Response (MPR)
時間枠：2 Years
|
MPR is defined as <10% viable tumor within resection, at time of surgery. |
2 Years
|
|
Significant Tumor Necrosis (STN)
時間枠：2 Years
|
STN is defined as necrosis of >70% of tumor base on pathologic analysis of gross tumor resection at time of surgery. |
2 Years
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Surgery
時間枠：2 Years
|
Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection. |
2 Years
|
|
Percent of individuals who experience adverse events
時間枠：2 Years
|
Safety and Tolerability defined by the percent of individuals who experience adverse events at any point during the neoadjuvant period, or within 30 days following the final dose of nivolumab received. |
2 Years
|
|
Percent of individuals who experience radiographic response
時間枠：2 Years
|
As per RECIST v1.1 as determined by pre-surgical imaging, following receipt of the neoadjuvant therapy. For NSCLC this will be based on CT imaging, while for HCC this imaging will be based on MRI radiographic post-contract subtraction. |
2 Years
|
|
Progression-free survival (PFS)
時間枠：2 Years
|
Defined as the time, in days, between treatment initiation and when the patient is found to have recurrent and/or metastatic disease on imaging, or death for any reason. |
2 Years
|
|
Overall Survival (OS)
時間枠：5 Years
|
Defined as the time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology. |
5 Years
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Thomas Marron, MD PhD、Icahn School of Medicine at Mount Sinai
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
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
その他の研究ID番号
- GCO 19-1754
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
米国FDA規制機器製品の研究
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