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Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.

2022年1月17日 更新者：Novartis Pharmaceuticals

A Phase I/II, Open Label, Multicenter Study of the Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 Administered to Patients With Advanced Malignancies

This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation (phase 1) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion (phase 2) which characterized treatment of LAG525 in combination with PDR001 at the MTD or RP2D.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This was a Phase 1/2, multi-center, open-label study comprising a Phase 1 dose escalation part followed by a Phase 2 dose expansion part.

During the Phase 1 dose escalation part patients with any advanced solid tumor received the study treatment until the MTD was reached or a lower RP2D was established. The study had the following 3 dose escalation parts: 1) Single-agent LAG525; 2) Single-agent LAG525 in Japanese patients; 3) Combination of LAG525 with PDR001.

Once the RP2D or MTD had been determined in the escalation parts, additional patients were to be enrolled in the Phase 2 expansion parts in order to assess the preliminary anti-tumor activity. Phase 2 expansion cohorts testing single-agent LAG525 were not opened for enrollment based on emerging data including but not limited to preliminary anti-tumor activity. Phase 2 expansion cohorts for the combination of LAG525 with PDR001 were opened and 5 tumor types were assessed: 1) Non-small cell lung cancer (NSCLC); 2) Melanoma; 3) Renal cell cancer (RCC); 4) Mesothelioma; 5) Triple negative breast cancer (TNBC). The efficacy and safety of the combination of LAG525 with PDR001 in these tumor types was assessed in both the PD-1/PD-L1 pre-treated and naïve settings.

研究の種類

介入

入学 (実際)

490

段階

  • フェーズ2
  • 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

  • アメリカ
    • New York
      • New York、New York、アメリカ、10032
        • Columbia University Medical Center SC LAG X2101C
      • New York、New York、アメリカ、10065
        • Memorial Sloan Kettering Cancer Center SC
    • North Carolina
      • Durham、North Carolina、アメリカ、27704
        • Duke Clinical Research Institute SC
    • Texas
      • Houston、Texas、アメリカ、77030
        • University of Texas MD Anderson Cancer Center
      • San Antonio、Texas、アメリカ、78229
        • Cancer Therapy and Research Center UT Health Science Center CTRC 2
    • Utah
      • Salt Lake City、Utah、アメリカ、84112
        • Huntsman Cancer Institute Huntsman Cancer Institute
  • イタリア
    • MI
      • Milano、MI、イタリア、20133
        • Novartis Investigative Site
    • MO
      • Modena、MO、イタリア、41124
        • Novartis Investigative Site
  • オーストラリア
    • New South Wales
      • Westmead、New South Wales、オーストラリア、2145
        • Novartis Investigative Site
    • Victoria
      • Heidelberg、Victoria、オーストラリア、3084
        • Novartis Investigative Site
  • カナダ
    • Alberta
      • Edmonton、Alberta、カナダ、T6G 1Z2
        • Novartis Investigative Site
    • Ontario
      • Toronto、Ontario、カナダ、M5G 2M9
        • Novartis Investigative Site
  • シンガポール
      • Singapore、シンガポール、119228
        • Novartis Investigative Site
      • Singapore、シンガポール、169610
        • Novartis Investigative Site
  • スペイン
      • Madrid、スペイン、28009
        • Novartis Investigative Site
    • Catalunya
      • Barcelona、Catalunya、スペイン、08035
        • Novartis Investigative Site
  • ドイツ
      • Heidelberg、ドイツ、69120
        • Novartis Investigative Site
      • Wuerzburg、ドイツ、97080
        • Novartis Investigative Site
  • フランス
      • Lyon Cedex、フランス、69373
        • Novartis Investigative Site
      • Saint-Herblain Cédex、フランス、44805
        • Novartis Investigative Site
  • ベルギー
      • Leuven、ベルギー、3000
        • Novartis Investigative Site
  • 台湾
      • Taipei、台湾、10002
        • Novartis Investigative Site
  • 日本
    • Fukuoka
      • Fukuoka-city、Fukuoka、日本、811-1395
        • Novartis Investigative Site
  • 香港
      • Hong Kong、香港
        • Novartis Investigative Site

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:

Phase I part:

- Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists

Phase II part:

  • Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have had disease progression following their last prior therapy and fit into one of the following groups:
  • Group 1: NSCLC
  • Group 2: Melanoma
  • Group 3: Renal cancer
  • Group 4: Mesothelioma
  • Group 5: TNBC
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  • Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy.

Exclusion Criteria:

  • History of severe hypersensitivity reactions to study treatment ingredients or other mAbs
  • Active, known or suspected autoimmune disease
  • Active infection requiring systemic antibiotic therapy
  • HIV infection. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Patients receiving chronic treatment with systemic steroid therapy, other than replacement-dose corticosteroids in the setting of adrenal insufficiency
  • Patients receiving systemic treatment with any immunosuppressive medication
  • Use of live vaccines against infectious disease within 4 weeks of initiation of study treatment
  • Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment.
  • Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks
  • History of drug-induced pneumonitis or current pneumonitis.

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：非ランダム化
  • 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
実験的：Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
実験的：Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
実験的：Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
実験的：Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
実験的：Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
実験的：Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
実験的：Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
実験的：Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
実験的：Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
実験的：Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
実験的：Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
実験的：Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion
実験的：Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
薬：LAG525
LAG525 was administered via intravenous (i.v.) infusion
薬：PDR001
PDR001 was administered via i.v. infusion

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
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
時間枠：15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
時間枠：From start of treatment until end of treatment, assessed up to 2.6 years

Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR).

For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.

ORR is reported by tumor type.
From start of treatment until end of treatment, assessed up to 2.6 years

二次結果の測定

結果測定
メジャーの説明
時間枠
Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years.
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants in each category (Rest of the World (ROW) patients, Japanese patients) with AEs and SAEs are reported in this record.
From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years.
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years.
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants with AEs and SAEs is reported for each tumor type.
From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years.
Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
時間枠：From start of treatment until end of treatment, assessed up to 4.4 years.

Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001.

Japanese patients were not treated with PDR001 and therefore the dose reductions and dose interruptions of this study drug are not applicable.
From start of treatment until end of treatment, assessed up to 4.4 years.
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
時間枠：From start of treatment until end of treatment, assessed up to 2.6 years.

Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001.

The number of participants with dose reductions and dose interruptions of both study drugs is reported for each tumor type.
From start of treatment until end of treatment, assessed up to 2.6 years.
Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001
時間枠：From start of treatment until end of treatment, assessed up to 4.4 years.

Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day).

Japanese patients were not treated with PDR001 and therefore the RDI of this study drug is not applicable.
From start of treatment until end of treatment, assessed up to 4.4 years.
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
時間枠：From start of treatment until end of treatment, assessed up to 2.6 years.

Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day).

The RDI of both study drugs is reported for each tumor type.
From start of treatment until end of treatment, assessed up to 2.6 years.
Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Phase 1: Terminal Elimination Half-life (T1/2) of LAG525
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.

Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.

Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.

Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Phase 1: Terminal Elimination Half-life (T1/2) of PDR001
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.

Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
時間枠：pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Phase 1: Number of Participants With Anti-LAG525 Antibodies
時間枠：Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).
Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).
Phase 2: Number of Participants With Anti-LAG525 Antibodies
時間枠：Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).
Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).
Phase 1: Number of Participants With Anti-PDR001 Antibodies
時間枠：Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).
Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).
Phase 2: Number of Participants With Anti-PDR001 Antibodies
時間枠：Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).
Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).
Phase 1: Overall Response Rate (ORR) Per RECIST 1.1
時間枠：From start of treatment until end of treatment, assessed up to 4.4 years

Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR).

For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.

ORR is reported for ROW and Japanese patients.
From start of treatment until end of treatment, assessed up to 4.4 years
Phase 1: Overall Response Rate (ORR) Per irRC
時間枠：From start of treatment until end of treatment, assessed up to 4.4 years

TTumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR).

For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters.

ORR is reported for ROW and Japanese patients.
From start of treatment until end of treatment, assessed up to 4.4 years
Phase 2: Overall Response Rate (ORR) Per irRC
時間枠：From start of treatment until end of treatment, assessed up to 2.6 years

Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR).

For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters.

ORR is reported by tumor type.
From start of treatment until end of treatment, assessed up to 2.6 years
Phase 1: Disease Control Rate (DCR) Per RECIST 1.1
時間枠：From start of treatment until end of treatment, assessed up to 4.4 years

Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD).

For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression.

DCR is reported for ROW and Japanese patients.
From start of treatment until end of treatment, assessed up to 4.4 years
Phase 1: Disease Control Rate (DCR) Per irRC
時間枠：From start of treatment until end of treatment, assessed up to 4.4 years

Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD).

For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression.

DCR is reported for ROW and Japanese patients.
From start of treatment until end of treatment, assessed up to 4.4 years
Phase 2: Disease Control Rate (DCR) Per RECIST 1.1
時間枠：From start of treatment until end of treatment, assessed up to 2.6 years

Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD).

For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression.

DCR is reported by tumor type.
From start of treatment until end of treatment, assessed up to 2.6 years
Phase 2: Disease Control Rate (DCR) Per irRC
時間枠：From start of treatment until end of treatment, assessed up to 2.6 years

Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD).

For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression.

DCR is reported by tumor type.
From start of treatment until end of treatment, assessed up to 2.6 years
Phase 1: Duration of Response (DOR) Per RECIST 1.1
時間枠：From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 4.4 years

DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment.

Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1.
From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 4.4 years
Phase 1: Duration of Response (DOR) Per irRC
時間枠：From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 4.4 years

DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment.

Tumor response was based on local investigator assessment and the assessment criteria was irRC.
From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 4.4 years
Phase 2: Duration of Response (DOR) Per RECIST 1.1
時間枠：From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 2.6 years

DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment.

Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1.

DOR is reported by tumor type.
From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 2.6 years
Phase 2: Duration of Response (DOR) Per irRC
時間枠：From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 2.6 years

DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment.

Tumor response was based on local investigator assessment and the assessment criteria was irRC.

DOR is reported by tumor type.
From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 2.6 years
Phase 1: Progression-free Survival (PFS) Per RECIST 1.1
時間枠：From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years

PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.

Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1.

PFS is reported for ROW and Japanese patients.
From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years
Phase 1: Progression-free Survival (PFS) Per irRC
時間枠：From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years

PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.

Tumor response was based on local investigator assessment and the assessment criteria was irRC.

PFS is reported for ROW and Japanese patients.
From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years
Phase 2: Progression-free Survival (PFS) Per RECIST 1.1
時間枠：From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years

PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.

Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1.

PFS is reported by tumor type.
From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years
Phase 2: Progression-free Survival (PFS) Per irRC
時間枠：From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years

PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.

Tumor response was based on local investigator assessment and the assessment criteria was irRC.

PFS is reported by tumor type.
From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years

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

Novartis Pharmaceuticals

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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)

2015年6月17日

一次修了 (実際)

2020年12月31日

研究の完了 (実際)

2020年12月31日

試験登録日

最初に提出

2015年5月9日

QC基準を満たした最初の提出物

2015年5月29日

最初の投稿 (見積もり)

2015年6月2日

学習記録の更新

投稿された最後の更新 (実際)

2022年2月10日

QC基準を満たした最後の更新が送信されました

2022年1月17日

最終確認日

2022年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CLAG525X2101C
  • 2015-000449-21 (EudraCT番号)

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?

未定

IPD プランの説明

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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

はい

米国FDA規制機器製品の研究

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。

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