進行性固形腫瘍の参加者におけるペギロデカキン（LY3500518）の第1相研究 (IVY)
進行性固形腫瘍患者におけるAM0010の忍容性、安全性、最大耐用量、予備的臨床活性、および薬物動態を評価するための第1相、非盲検用量漸増ファースト・イン・ヒューマン試験
調査の概要
状態
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90024
- UCLA Medical Hematology & Oncology
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San Francisco、California、アメリカ
- UCSF
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Colorado
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Denver、Colorado、アメリカ、80218
- Sarah Cannon Research Institute at HealthONE
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Florida
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Sarasota、Florida、アメリカ、34232
- Florida Cancer Specialists & Research Institute
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Dana Farber Cancer Institute
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New York
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New York、New York、アメリカ、10065
- Memorial Sloan Kettering Cancer Center
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73104
- Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
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Tennessee
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Nashville、Tennessee、アメリカ、37203
- Sarah Cannon Research Institute
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Texas
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Houston、Texas、アメリカ、77030
- The University of Texas M.D. Anderson Cancer Center
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San Antonio、Texas、アメリカ、78229
- South Texas Accelerated Research Therapeutics
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
説明
包含基準:
パート A エスカレーション コホート:
o 組織学的または細胞学的に確認された進行性悪性固形腫瘍、黒色腫、去勢抵抗性前立腺がん (CRPC)、卵巣がん (OVCA)、腎細胞がん、結腸直腸がん (CRC)、膵臓がんまたは非小細胞肺がん (NSCLC) に限定難治性、不耐性、標準治療がない、または参加者が既存の治療を拒否する場合
パート A 拡張コホート、パート B および C エスカレーションおよび拡張コホート:
- すべての組織学的診断または組織起源の腫瘍が登録される場合があります
参加者は、その疾患に対する以前の標準的な治癒的化学療法に失敗した、既存の治療法を拒否した、またはペギロデカキンが追加された提案された化学療法レジメンがその疾患に対して許容可能な標準治療を表している必要があります。
- -irRCに従って測定可能または評価可能な疾患、または前立腺癌ワーキンググループ2基準（PCWG2）によって評価可能な骨転移性疾患 去勢抵抗性前立腺癌（CRPC）
- 18歳以上
- 0 または 1 のパフォーマンス ステータス
- 適切な臓器機能
除外基準:
- 血液悪性腫瘍
- 妊娠中または授乳中
- -多発性硬化症やギランバレーなどの神経障害の現在または病歴、または炎症性中枢神経系/末梢神経系（CNS / PNS）障害
- -過去6か月以内の心筋梗塞
- 薬を必要とする不安定狭心症または不安定心不整脈
- 過去28日以内の手術
- 全身性真菌、細菌、ウイルス、またはその他の感染症
- -過去6か月以内の出血素因の病歴
- ヒト免疫不全ウイルス（HIV）、C型肝炎、またはB型肝炎に陽性
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：非ランダム化
- 介入モデル：単一グループの割り当て
- 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：Part A: Pegilodecakin 0.08/0.1 mg
Participants received 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
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実験的：Part A: Pegilodecakin 0.2/0.25 mg
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
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12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
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実験的：Part A: Pegilodecakin 0.4/0.5 mg
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
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12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
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実験的：Part A: Pegilodecakin 0.8/1 mg
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
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12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
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実験的：Part A: Pegilodecakin 1.6/2 mg
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
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12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
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実験的：Part A: Pegilodecakin 3.2/4 mg
Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
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12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
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実験的：Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
他の名前：
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実験的：Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
他の名前：
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実験的：Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
他の名前：
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実験的：Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-Fluorouracil (FU) 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
他の名前：
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実験的：Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
他の名前：
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実験的：Part C: Pegilodecakin 0.8/1 mg + FOLFOX
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
他の名前：
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実験的：Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with Gemcitabine 1000 mg/m2 IV over 30 minutes plus nab-paclitaxel 125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.
他の名前：
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実験的：Part E: Pegilodecakin 0.8/1 mg + Capecitabine
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Capecitabine 1000 mg/m² orally twice daily (BID) on Days 1 through 14 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Capecitabine administered orally twice daily for 14 days out of every 21 days.
他の名前：
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実験的：Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Paclitaxel 80 mg/m2 IV over 3 hours on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)
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実験的：Part G: Pegilodecakin 0.8/1 mg + Pazopanib
Participants received a 0.8 or 1 mg of Pegilodecakin QD administered SC with Pazopanib 800 mg orally QD. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Pazopanib administered orally daily continuously
他の名前：
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実験的：Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
他の名前：
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実験的：Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
他の名前：
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実験的：Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab
Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
他の名前：
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実験的：Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an Area Under the Curve of 2 mg/mL x min (AUC2) IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
他の名前：
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実験的：Part I: Pegilodecakin 1.6/2 mg + Nivolumab
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
他の名前：
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実験的：Part I: Pegilodecakin 0.8/1 mg + Nivolumab
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
他の名前：
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実験的：Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an AUC2 IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
12 か月までのペギロデカキンの毎日の皮下注射
他の名前：
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
他の名前：
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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 Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin
時間枠：From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)
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The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.
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From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)
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Pharmacokinetic (PK): Serum Concentration of Pegilodecakin
時間枠：Day 29
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Serum concentration of Pegilodecakin is reported.
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Day 29
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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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Number of Participants With Anti-Pegilodecakin Antibody Formation
時間枠：Up to 63 Months
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Number of participants with treatment-emergent anti-Pegilodecakin antibodies, defined as participants with at least one postbaseline anti-drug antibody (ADA) titer ≥4-fold increase from baseline (treatment-boosted) or ADA present with titer ≥1:20 if baseline ADA was negative (treatment-induced), analyses were conducted in the TE ADA-evaluable population.
A participant is TE ADA evaluable if at least one non-missing ADA result is available at both baseline and postbaseline.
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Up to 63 Months
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Part A: Number of Participants With Overall Response Rate (ORR)
時間枠：From Date of First Dose of study drug until Disease Progression or Death (Up to 54 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR). irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of study drug until Disease Progression or Death (Up to 54 months)
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Part B: Number of Participants With Overall Response Rate (ORR)
時間枠：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
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Part C: Number of Participants With Overall Response Rate (ORR)
時間枠：From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months)
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Part D: Number of Participants With Overall Response Rate (ORR)
時間枠：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 7 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 7 months)
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Part E: Number of Participants With Overall Response Rate (ORR)
時間枠：From Date of First Dose of study drug until Disease Progression or Death (Upto 12 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of study drug until Disease Progression or Death (Upto 12 months)
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Part F: Number of Participants With Overall Response Rate (ORR)
時間枠：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 3 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 3 months)
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Part G: Number of Participants With Overall Response Rate (ORR)
時間枠：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
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Part H: Number of Participants With Overall Response Rate (ORR)
時間枠：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 48 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 48 months)
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Part I: Number of Participants With Overall Response Rate (ORR)
時間枠：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 50 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 50 months)
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Part J: Number of Participants With Overall Response Rate (ORR)
時間枠：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 8 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 8 months)
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協力者と研究者
スポンサー
協力者
捜査官
- スタディディレクター：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company
出版物と役立つリンク
一般刊行物
- Naing A, Papadopoulos KP, Autio KA, Ott PA, Patel MR, Wong DJ, Falchook GS, Pant S, Whiteside M, Rasco DR, Mumm JB, Chan IH, Bendell JC, Bauer TM, Colen RR, Hong DS, Van Vlasselaer P, Tannir NM, Oft M, Infante JR. Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients With Advanced Solid Tumors. J Clin Oncol. 2016 Oct 10;34(29):3562-3569. doi: 10.1200/JCO.2016.68.1106.
- Naing A, Wong DJ, Infante JR, Korn WM, Aljumaily R, Papadopoulos KP, Autio KA, Pant S, Bauer TM, Drakaki A, Daver NG, Hung A, Ratti N, McCauley S, Van Vlasselaer P, Verma R, Ferry D, Oft M, Diab A, Garon EB, Tannir NM. Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial. Lancet Oncol. 2019 Nov;20(11):1544-1555. doi: 10.1016/S1470-2045(19)30514-5. Epub 2019 Sep 25.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
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QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
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
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本研究に関する用語
キーワード
追加の関連 MeSH 用語
- 泌尿生殖器疾患
- 生殖器疾患
- 内分泌系疾患
- 性器腫瘍、男性
- 泌尿生殖器腫瘍
- 部位別新生物
- 生殖器疾患、男性
- 前立腺疾患
- 男性の泌尿生殖器疾患
- 腎臓病
- 泌尿器疾患
- 女性の泌尿生殖器疾患
- 女性の泌尿生殖器疾患と妊娠合併症
- 腸の病気
- 気道疾患
- 組織型別の新生物
- 消化器腫瘍
- 消化器系腫瘍
- 消化器系疾患
- 消化器疾患
- 腸の腫瘍
- 直腸疾患
- 生殖器疾患、女性
- 肺疾患
- 内分泌腺腫瘍
- 膵臓の病気
- 新生物、腺および上皮
- 腺癌
- 気道腫瘍
- 胸部腫瘍
- 結腸疾患
- 肺新生物
- 卵巣疾患
- 付属器疾患
- 性器腫瘍、女性
- 性腺疾患
- 皮膚疾患
- 乳房の病気
- 泌尿器科の新生物
- がん
- 神経外胚葉性腫瘍
- 新生物、生殖細胞および胚
- 新生物、神経組織
- 腎腫瘍
- がん、気管支原性
- 気管支腫瘍
- 神経内分泌腫瘍
- 母斑とメラノーマ
- 皮膚腫瘍
- 皮膚および結合組織疾患
- 新生物
- 前立腺腫瘍
- 結腸直腸腫瘍
- 卵巣腫瘍
- 乳房腫瘍
- 膵臓の新生物
- がん、腎細胞
- がん、非小細胞肺
- メラノーマ
- アミノ酸、ペプチド、およびタンパク質
- タンパク質
- 有機化学物質
- 複素環化化合物、1リング
- 複素環化化合物
- 核酸、ヌクレオチド、およびヌクレオシド
- 炭化水素
- シクロパラフィン
- 炭化水素、環状
- 炭化水素、周期的
- テルペン
- 抗体、モノクローナル、ヒト化
- 抗体、モノクローナル
- 抗体
- 免疫グロブリン
- 免疫タンパク質
- 血液タンパク質
- 血清グロブリン
- グロブリン
- 無機化学物質
- 塩素化合物
- 窒素化合物
- 調整錯体
- タキソイド
- シクロデカン
- Diterpenes
- デオキシシチジン
- シチジン
- ピリミジンヌクレオシド
- ピリミジン
- ヌクレオシド
- ウラシル
- ピリミジノン
- プラチナ化合物
- デオキシリボヌクレオシド
- フルオロウラシル
- ドセタキセル
- カペシタビン
- オキサリプラチン
- ニボルマブ
- ゲムシタビン
- カルボプラチン
- パクリタキセル
- シスプラチン
- ペンブロリズマブ
- FOLFOXプロトコル
- パゾパニブ
- pegilodecakin
- AM0010
その他の研究ID番号
- 17159
- J1L-AM-JZGA (その他の識別子：Eli Lilly and Company)
- AM0010-001 (その他の識別子：ARMO BioSciences)
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?
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
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。