ペンブロリズマブ（MK-3475）試験（MK-3475-587/KEYNOTE-587）で現在治療中または追跡調査中の進行腫瘍患者を対象とした長期安全性および有効性延長試験
基本情報
- NCT ID
- NCT03486873
- ステータス
- 募集中
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 3,500
- 治験依頼者名
- Merck Sharp & Dohme LLC
概要
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.
対象疾患
介入
依頼者（Sponsor）
実施施設 (50)
Keio University Hospital ( Site 3127)
Tokyo, Japan(RECRUITING)
独立行政法人国立病院機構大阪医療センター
Osaka, Japan(RECRUITING)
広島市医師会運営・安芸市民病院
Hiroshima, Japan(RECRUITING)
名古屋大学医学部附属病院
Nagoya, Aichi-ken, Japan(RECRUITING)
Saitama Medical University International Medical Center ( Site 3118)
Hidaka, Saitama, Japan(RECRUITING)
Cancer Institute Hospital of JFCR ( Site 3146)
Koto, Tokyo, Japan(RECRUITING)
獨協医科大学埼玉医療センター
Koshigaya, Saitama, Japan(RECRUITING)
Kyoto University Hospital ( Site 3181)
Kyoto, Japan(RECRUITING)
国家公務員共済組合連合会 虎の門病院
Minato-ku, Tokyo, Japan(RECRUITING)
札幌医科大学附属病院
Sapporo, Hokkaido, Japan(RECRUITING)
Cancer Institute Hospital of JFCR ( Site 3108)
Tokyo, Japan(RECRUITING)
東北大学病院
Sendai, Miyagi, Japan(RECRUITING)
National Hospital Organization Yamaguchi Ube Medical Center ( Site 3123)
Ube, Yamaguchi, Japan(RECRUITING)
筑波大学附属病院
Tsukuba, Ibaraki, Japan(RECRUITING)
関西医科大学附属病院
Hirakata, Osaka, Japan(RECRUITING)
独立行政法人国立病院機構 東名古屋病院
Nagoya, Aichi-ken, Japan(RECRUITING)
独立行政法人国立病院機構 九州がんセンター
Fukuoka, Japan(RECRUITING)
山口大学医学部附属病院
Ube, Yamaguchi, Japan(RECRUITING)
茨城県立中央病院
Kasama, Ibaraki, Japan(RECRUITING)
新潟大学医歯学総合病院
Niigata, Japan(RECRUITING)
Jichi Medical University Hospital ( Site 3141)
Shimotsuke, Tochigi, Japan(RECRUITING)
和歌山県立医科大学附属病院
Wakayama, Japan(RECRUITING)
大阪医科薬科大学病院
Takatsuki, Osaka, Japan(RECRUITING)
独立行政法人国立病院機構 九州医療センター
Fukuoka, Japan(RECRUITING)
聖マリアンナ医科大学病院
Kawasaki, Kanagawa, Japan(RECRUITING)
公益財団法人がん研究会 有明病院
Koto, Tokyo, Japan(RECRUITING)
独立行政法人国立病院機構四国がんセンター
Matsuyama, Ehime, Japan(RECRUITING)
Sapporo Kosei General Hospital ( Site 3172)
Sapporo, Hokkaido, Japan(RECRUITING)
Sapporo Kosei General Hospital ( Site 3172)
Sapporo, Hokkaido, Japan(RECRUITING)
Gifu University Hospital ( Site 3161)
Gifu, Japan(RECRUITING)
独立行政法人労働者健康安全機構 大阪労災病院
Sakai, Osaka, Japan(RECRUITING)
Kumamoto University Hospital ( Site 3179)
Kumamoto, Japan(COMPLETED)
National Cancer Center Hospital ( Site 3130)
Tokyo, Japan(RECRUITING)
学校法人帝京大学 帝京大学医学部附属病院
Tokyo, Japan(COMPLETED)
埼玉県立がんセンター
Kitaadachi-gun, Saitama, Japan(RECRUITING)
仙台厚生病院
Sendai, Miyagi, Japan(RECRUITING)
兵庫医科大学病院
Nishinomiya, Hyōgo, Japan(RECRUITING)
Yamaguchi University Hospital ( Site 3114)
Ube, Yamaguchi, Japan(RECRUITING)
久留米大学病院
Kurume, Fukuoka, Japan(RECRUITING)
新潟県立がんセンター新潟病院
Niigata, Niigata, Japan(COMPLETED)
愛媛県立今治病院
Tōon, Ehime, Japan(RECRUITING)
愛知県がんセンター
Nagoya, Aichi-ken, Japan(RECRUITING)
自治医科大学附属病院
Shimotsuke, Tochigi, Japan(RECRUITING)
Hyogo Medical University Hospital ( Site 3100)
Nishinomiya, Hyōgo, Japan(RECRUITING)
Kurume University Hospital ( Site 3105)
Kurume, Fukuoka, Japan(RECRUITING)
University of the Ryukyus Hospital ( Site 3155)
Ginowan, Okinawa, Japan(RECRUITING)
熊本大学病院
Kumamoto, Japan(RECRUITING)
近畿大学病院
Sakai, Osaka, Japan(RECRUITING)
東京科学大学病院
Bunkyō, Tokyo, Japan(RECRUITING)
東京科学大学 保健管理センター 湯島保健管理センター
Bunkyō, Tokyo, Japan(RECRUITING)