このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

以前に治療された進行性または転移した明細胞腎細胞癌の参加者における皮下ニボルマブと静脈内ニボルマブの研究 (CheckMate-67T)

2026年8月26日 更新者：Bristol-Myers Squibb

以前に全身療法を受けた進行性または転移性明細胞腎細胞癌の参加者におけるニボルマブの皮下製剤と静脈内ニボルマブの第3相、非盲検、無作為化、非劣性試験

The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

681

段階

  • フェーズ 3

アクセスの拡大

利用できない 臨床試験外。 拡張アクセス記録をご覧ください。

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

  • アイルランド
    • Dublin
      • Tallaght、Dublin、アイルランド
        • Local Institution - 0060
  • アメリカ
    • Illinois
      • Chicago、Illinois、アメリカ、60611
        • Local Institution
    • New York
      • Buffalo、New York、アメリカ、14263
        • Local Institution - 0025
    • Pennsylvania
      • West Reading、Pennsylvania、アメリカ、19611
        • Local Institution - 0088
  • アルゼンチン
    • Buenos Aires
      • Buenos Aires、Buenos Aires、アルゼンチン、C1426ANZ
        • Local Institution - 0038
      • Capital Federal、Buenos Aires、アルゼンチン、C1419AHN
        • Local Institution - 0095
      • Mar del Plata、Buenos Aires、アルゼンチン、7600
        • Local Institution - 0058
      • Pergamino、Buenos Aires、アルゼンチン、B2700CPM
        • Local Institution - 0037
    • Córdoba Province
      • Parana、Córdoba Province、アルゼンチン、5000
        • Local Institution - 0079
      • Río Cuarto、Córdoba Province、アルゼンチン、5800
        • Local Institution - 0030
    • Río Negro Province
      • Viedma、Río Negro Province、アルゼンチン、R8500ACE
        • Local Institution - 0066
    • San Juan Province
      • San Juan、San Juan Province、アルゼンチン、J5402DIL
        • Local Institution - 0056
  • イタリア
      • Cremona、イタリア、26100
        • Local Institution - 0033
      • Florence、イタリア、50134
        • Local Institution - 0008
      • Meldola、イタリア、47014
        • Local Institution - 0027
      • Milan、イタリア、20141
        • Local Institution - 0018
      • Milan、イタリア、20133
        • Local Institution
      • Padova、イタリア、35128
        • Local Institution - 0014
      • Parma、イタリア、43126
        • Local Institution - 0082
      • Pavia、イタリア、27100
        • Local Institution - 0092
      • Roma、イタリア、00168
        • Local Institution - 0100
      • Rome、イタリア、00152
        • Local Institution - 0091
      • Terni、イタリア、05100
        • Local Institution - 0057
  • スペイン
      • Barcelona、スペイン、08003
        • Local Institution - 0048
      • Barcelona、スペイン、08035
        • Local Institution - 0102
      • Barcelona、スペイン、08041
        • Local Institution - 0049
      • Madrid、スペイン、28026
        • Local Institution - 0072
      • Madrid、スペイン、28033
        • Local Institution - 0067
      • Madrid、スペイン、28046
        • Local Institution - 0074
      • Madrid、スペイン、28050
        • Local Institution - 0075
      • Sabadell、スペイン、08208
        • Local Institution - 0032
      • Santander、スペイン、39008
        • Local Institution - 0086
      • Seville、スペイン、31013
        • Local Institution - 0059
  • チェコ
      • Brno、チェコ、656 53
        • Local Institution - 0063
      • Hradec Králové、チェコ、500 05
        • Local Institution - 0036
      • Olomouc、チェコ、77900
        • Local Institution - 0020
      • Ostrava、チェコ、708 52
        • Local Institution - 0099
      • Prague、チェコ、140 59
        • Local Institution - 0010
      • Praha 8 Liben、チェコ、18081
        • Local Institution - 0106
  • チリ
    • Araucania
      • Temuco、Araucania、チリ
        • Local Institution - 0084
    • Santiago Metropolitan
      • Santiago、Santiago Metropolitan、チリ
        • Local Institution - 0005
      • Santiago、Santiago Metropolitan、チリ、7500653
        • Local Institution - 0104
      • Santiago、Santiago Metropolitan、チリ、7500921
        • Local Institution - 0076
    • Valparaiso
      • Viña del Mar、Valparaiso、チリ、2520598
        • Local Institution - 0077
  • トルコ（Türkiye）
      • Ankara、トルコ（Türkiye）、06230
        • Local Institution - 0026
      • Ankara、トルコ（Türkiye）、06590
        • Local Institution - 0097
      • Istanbul、トルコ（Türkiye）、34098
        • Local Institution - 0019
    • Bagcilar
      • Istanbul、Bagcilar、トルコ（Türkiye）、34284
        • Local Institution - 0035
  • ニュージーランド
      • Auckland、ニュージーランド、1023
        • Local Institution - 0053
      • Hamilton、ニュージーランド、3204
        • Local Institution - 0041
      • Palmerston North、ニュージーランド、4414
        • Local Institution - 0078
  • フィンランド
      • Tampere、フィンランド、33521
        • Local Institution - 0017
  • フランス
      • Nice、フランス、6189
        • Local Institution
      • Suresnes、フランス、92151
        • Local Institution - 0051
      • Villejuif、フランス、94800
        • Local Institution - 0068
  • ブラジル
    • Paraná
      • Curitiba、Paraná、ブラジル、80520-174
        • Local Institution - 0064
    • Rio Grande do Sul
      • Ijuí、Rio Grande do Sul、ブラジル、98700-000
        • Local Institution - 0107
      • Porto Alegre、Rio Grande do Sul、ブラジル、91350-200
        • Local Institution - 0039
    • Rio de Janeiro
      • Rio de Janeiro、Rio de Janeiro、ブラジル、20230-130
        • Local Institution - 0090
    • São Paulo
      • Barretos、São Paulo、ブラジル、014784-000
        • Local Institution - 0071
      • São José do Rio Preto、São Paulo、ブラジル、15090-000
        • Local Institution - 0070
      • São Paulo、São Paulo、ブラジル、01246-000
        • Local Institution - 0081
      • São Paulo、São Paulo、ブラジル、01327-0001
        • Local Institution - 0096
  • ポルトガル
      • Coimbra、ポルトガル、3030-075
        • Local Institution - 0050
      • Lisbon、ポルトガル、1500-650
        • Local Institution - 0052
  • ポーランド
      • Biała Podlaska、ポーランド、21-500
        • Local Institution - 0055
      • Bydgoszcz、ポーランド、85-796
        • Local Institution - 0062
      • Gdansk、ポーランド、80-214
        • Local Institution - 0083
      • Krakow、ポーランド、30-688
        • Local Institution - 0021
      • Krakow、ポーランド、31-115
        • Local Institution - 0098
      • Poznan、ポーランド、60-569
        • Local Institution - 0001
      • Warsaw、ポーランド、02-781
        • Local Institution - 0023
  • メキシコ
    • Coahuila
      • Torreón、Coahuila、メキシコ、27010
        • Local Institution - 0101
    • Mexico City
      • Tlalpan、Mexico City、メキシコ、14080
        • Local Institution - 0089
    • Nuevo León
      • Monterrey、Nuevo León、メキシコ、64460
        • Local Institution - 0103
      • Monterrey、Nuevo León、メキシコ、64710
        • Local Institution - 0031
    • Querétaro
      • Querétaro City、Querétaro、メキシコ、76000
        • Local Institution - 0065
      • Querétaro City、Querétaro、メキシコ、76090
        • Local Institution - 0085
    • San Luis Potosí
      • San Luis Potosí City、San Luis Potosí、メキシコ、78200
        • Local Institution - 0105
  • ルーマニア
      • Bucharest、ルーマニア、022238
        • Local Institution - 0024
      • Cluj-Napoca、ルーマニア、400132
        • Local Institution - 0002
      • Cluj-Napoca、ルーマニア、400641
        • Local Institution - 0040
      • Craiova、ルーマニア、200347
        • Local Institution - 0016
  • ロシア
      • Chelyabinsk、ロシア、454087
        • SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
      • Ivanovo、ロシア、153040
        • Ivanovo Regional Oncology Dispensary
      • Moscow、ロシア、125284
        • Hertzen Moscow Oncology Research Center
      • Nizghiy Novgorod、ロシア、603000
        • Local Institution
      • Omsk、ロシア、644013
        • Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
      • Saint Petersburg、ロシア、197022
        • LLC Eurocityclinic

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features
  • Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV)
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria within 28 days prior to randomization
  • Received no more than 2 prior systemic treatment regimens
  • Intolerance or progression on or after the last treatment regimen received and within 6 months prior to randomization
  • Karnofsky PS ≥ 70 at screening
  • Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Untreated, symptomatic central nervous system (CNS) metastases

  • Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization

  • Active, known, or suspected autoimmune disease

  • Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, or a current CD4 count < 350 cells/μL. Participants with HIV are eligible if:

    1. They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization
    2. They continue on ART as clinically indicated while enrolled on study
    3. CD4 counts and viral load are monitored per standard of care by a local health care provider
    4. Inclusion of participants with HIV should be based on Investigator clinical judgment in consultation with the Medical Monitor NOTE: Testing for HIV must be performed at sites where mandated locally. HIV-positive participants must be excluded where mandated locally

  • Serious or uncontrolled medical disorders including for example, active severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4 weeks prior to screening. In the case of prior SARS-CoV-2 infection, acute symptoms must have resolved based on investigator clinical judgment and, in consultation with Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment to be eligible

  • Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death ligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways

  • Treatment with any live attenuated vaccine within 30 days of first study treatment

Other protocol-defined inclusion/exclusion criteria apply

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：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：アームA
生物学的：Nivolumab and rHuPH20

Specified dose on specified days

他の名前：
  • BMS-986298
アクティブコンパレータ：アームB
生物学的：Nivolumab

Specified dose on specified days

他の名前：
  • BMS-936558
  • オプジーボ
実験的：アームC
生物学的：Nivolumab and rHuPH20

Specified dose on specified days

他の名前：
  • BMS-986298
実験的：アームD
生物学的：Nivolumab and rHuPH20

Specified dose on specified days

他の名前：
  • BMS-986298

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
Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale
時間枠：Pre-dose (Day 1 to Day 28)

Plasma samples were collected to assess the serum concentration.
Pre-dose (Day 1 to Day 28)
Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale
時間枠：Pre-dose (Day 1 to Day 28)

Plasma samples were collected to assess the serum concentration.
Pre-dose (Day 1 to Day 28)

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR) Per BICR
時間枠：From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
Trough Serum Concentration of Nivolumab at Day 28 (Cmind28)
時間枠：Pre-dose at Day 28

Blood samples were collected to assess serum concentration.
Pre-dose at Day 28
Maximum Serum Concentration of Nivolumab After the First Dose (Cmax1)
時間枠：Post dose (Day 1)

Blood samples were collected to assess serum concentration.
Post dose (Day 1)
Peak Serum Concentration of Nivolumab at Steady State (Cmaxss)
時間枠：Pre-dose (Day 1 to Day 28)

Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)
Time-averaged Serum Concentration of Nivolumab at Steady State (Cavgss)
時間枠：Pre-dose (Day 1 to Day 28)

Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)
Trough Serum Concentration of Nivolumab (Ctrough)
時間枠：Pre-dose at Week 17

Blood samples were collected to assess serum concentration.
Pre-dose at Week 17
Time to Maximum Serum Concentration of Nivolumab at Day 1 (Tmax1)
時間枠：Post dose (Day 1)

Blood samples were collected to assess serum concentration.
Post dose (Day 1)
Trough Serum Concentration of Nivolumab at Steady State (Cminss)
時間枠：Pre dose (Day 1 to Day 28)

Blood samples were collected to assess serum concentration.
Pre dose (Day 1 to Day 28)
Number of Participants With Adverse Events, Serious Adverse Events, AEs Leading to Discontinuation and Death
時間枠：First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)

AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, results in a congenital abnormality or birth defect, or is an important medical event that may not result in death, be life-threatening, or require hospitalization, but may require medical or surgical intervention to prevent any of the outcomes listed above.
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Grade 3/4 Laboratory Abnormalities
時間枠：First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)

Blood samples were collected for assessment of laboratory test results. All abnormalities were graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
Disease Control Rate (ORR) Per BICR
時間枠：From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Disease control rate (DCR) is defined as the percentage of participants who achieve a BOR of confirmed Complete Response (CR), confirmed Partial Response (PR), or stable disease (SD), based on BICR assessments (using RECIST 1.1) divided by the number of all randomized participants. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
Time to Response (TTR) Per BICR
時間枠：From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Time to response (TTR) assessed by BICR is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.

CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
Duration of Response (DoR) Per BICR
時間枠：From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR is complete disappearance of all target lesions except nodal disease; all target nodes must decrease to normal size (short axis < 10 mm). PR is ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. Disease progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
Overall Survival
時間枠：From first dose to the date of death (up to approximately 26 months)

Overall survival is defined as the time from the first dosing date (or from randomization/on treatment) to the date of death from any cause.
From first dose to the date of death (up to approximately 26 months)
Number of Participants With Drug-Related Local Injection- or Infusion-Site Reactions
時間枠：First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 27 months)
First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 27 months)
Number of Participants With Incidence of Anti-nivolumab Antibodies
時間枠：First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)

ADA Positive is a subject with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater [≥]than baseline positive titer) at any time after initiation of treatment.
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)

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

Bristol-Myers Squibb

捜査官

  • スタディディレクター：Bristol-Myers Squibb、Bristol-Myers Squibb

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

便利なリンク

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)

2021年5月21日

一次修了 (実際)

2025年7月29日

研究の完了 (推定)

2027年5月10日

試験登録日

最初に提出

2021年3月16日

QC基準を満たした最初の提出物

2021年3月19日

最初の投稿 (実際)

2021年3月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月22日

QC基準を満たした最後の更新が送信されました

2026年8月26日

最終確認日

2026年8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

  • CA209-67T
  • 2020-003655-15 (EudraCT番号)
  • U1111-1255-9514 (レジストリ識別子：WHO)

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?

はい

IPD プランの説明

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD 共有時間枠

See Plan Description

IPD 共有アクセス基準

See Plan Description

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • CSR

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。

購読する