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하위 연구 06E: 식도암의 병용 요법에 대한 우산 연구(MK-3475-06E/KEYMAKER-U06)

2026년 10월 23일 업데이트: Merck Sharp & Dohme LLC

1L 국소 진행성 절제 불가능/전이성 식도암 참가자를 대상으로 화학요법 유무에 관계없이 Pembrolizumab(MK-3475)과 결합된 조사 약물에 대한 1/2상 오픈 라벨, 엄브렐라 플랫폼 설계 연구: KEYMAKER-U06 하위 연구 06E

Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unresectable, which means it has spread into tissue near where it started and cannot be completely removed by surgery, or metastatic, which means it has spread to other body parts.

Available treatments for these types of ESCC include pembrolizumab and chemotherapy. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing.

Researchers want to learn about giving pembrolizumab and investigational agents, with or without chemotherapy to treat ESCC. Ifinatamab deruxtecan (I-DXd), is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.

The main goal of this study is to learn about the safety of investigational agents and pembrolizumab with or without chemotherapy and if people tolerate them. Researchers also want to learn how cancer responds (gets smaller or goes away) to the study treatments.

연구 개요

상태

모병

정황

식도 편평 세포 암종

개입 / 치료

상세 설명

The master protocol is MK-3475-U06.

연구 유형

중재적

등록 (추정된)

298

단계

2 단계
1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Toll Free Number
전화번호: 1-888-577-8839
이메일: Trialsites@msd.com

연구 장소

노르웨이
- - Oslo, 노르웨이, 0379
    - 모병
    - Oslo Universitetssykehus Radiumhospitalet ( Site 1501)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +4723026600
대만
- - Kaohsiung City, 대만, 83301
    - 모병
    - Kaohsiung Chang Gung Memorial Hospital ( Site 1003)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +88677317123x3679
  - Taichung, 대만, 40707
    - 모병
    - China Medical University Hospital ( Site 1007)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: 886-4-22052121
  - Tainan, 대만, 704302
    - 모병
    - National Cheng Kung University Hospital ( Site 1001)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +88662353535x4559
  - Taipei, 대만, 100225
    - 모병
    - National Taiwan University Hospital ( Site 1000)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +886223123456x67680
  - Taipei, 대만, 11217
    - 모병
    - Taipei Veterans General Hospital ( Site 1005)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +886228712121
  - Taipei, 대만, 106
    - 모병
    - National Taiwan University Cancer Center ( Site 1010)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: 886223220322
  - Taoyuan, 대만, 33305
    - 모병
    - Chang Gung Memorial Hospital - Linkou Branch ( Site 1006)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +88633281200 #8825
- Kaohsiung
  - Kaoshiung, Kaohsiung, 대만, 807
    - 모병
    - Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1009)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +8867-3121101#7451
대한민국
- - Seoul, 대한민국, 05505
    - 모병
    - Asan Medical Center ( Site 9901)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +82230107179
  - Seoul, 대한민국, 06351
    - 모병
    - Samsung Medical Center ( Site 9900)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +82234106518
- Kyonggi-do
  - Goyang-si, Kyonggi-do, 대한민국, 10408
    - 모병
    - National Cancer Center ( Site 9902)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +82319201694
독일
- Baden-Wurttemberg
  - Heidelberg, Baden-Wurttemberg, 독일, 69120
    - 모병
    - NCT-Department of Medical Oncology ( Site 1809)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +49 62215637784
- Free and Hanseatic City of Hamburg
  - Erdgeschoss, Free and Hanseatic City of Hamburg, 독일, 22297
    - 모병
    - HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 1807)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +4940360352246
- North Rhine-Westphalia
  - Düsseldorf, North Rhine-Westphalia, 독일, 40225
    - 모병
    - Universitaetsklinikum Duesseldorf ( Site 1808)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +492118108751
- Saxony
  - Dresden, Saxony, 독일, 01307
    - 모병
    - Universitätsklinikum Carl Gustav Carus - Medical Oncology ( Site 1806)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +493514583016
미국
- Pennsylvania
  - Pittsburgh, Pennsylvania, 미국, 15232
    - 모병
    - UPMC Hillman Cancer Center ( Site 1904)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: 412-623-8974
브라질
- - São Paulo, 브라질, 01246-000
    - 모병
    - ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1302)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: 551138932000
- Rio Grande do Norte
  - Natal, Rio Grande do Norte, 브라질, 59062-000
    - 모병
    - Liga Norte Riograndense Contra o Cancer ( Site 1301)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +55 84 4009-5595
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, 브라질, 91010-004
    - 모병
    - Hospital Nossa Senhora da Conceicao ( Site 1300)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +555133572092
- São Paulo
  - São Paulo, São Paulo, 브라질, 03102-002
    - 모병
    - IBCC - Instituto Brasileiro de Controle do Cancer ( Site 1303)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: 551144500300
스위스
- - Geneva, 스위스, 1211
    - 모병
    - Hopitaux Universitaires de Geneve HUG. ( Site 1701)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +41 (0)22 372 95 77
- Kanton Graubünden
  - Chur, Kanton Graubünden, 스위스, 7000
    - 모병
    - Kantonsspital Graubuenden ( Site 1700)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +41 81 256 61 11
싱가포르
- Central Singapore
  - Singapore, Central Singapore, 싱가포르, 119074
    - 모병
    - National University Hospital ( Site 9800)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +65 6908 2222
이탈리아
- Lombardy
  - Milan, Lombardy, 이탈리아, 20132
    - 모병
    - Ospedale San Raffaele-Oncologia Medica ( Site 9201)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +390226437615
- Veneto
  - Padova, Veneto, 이탈리아, 35128
    - 모병
    - Istituto Oncologico Veneto IRCCS ( Site 9202)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: 390498215910
일본
- Aichi-ken
  - Nagoya, Aichi-ken, 일본, 464-8681
    - 모병
    - Aichi Cancer Center ( Site 9702)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +81-52-762-6111
- Chiba
  - Kashiwa, Chiba, 일본, 277-8577
    - 모병
    - National Cancer Center Hospital East ( Site 9701)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +81-4-7133-1111
- Tokyo
  - Chūō, Tokyo, 일본, 104-0045
    - 모병
    - National Cancer Center Hospital ( Site 9700)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +81-3-3542-2511
중국
- Anhui
  - Hefei, Anhui, 중국, 230601
    - 모병
    - The Second Affiliated Hospital of Anhui Medical University ( Site 9511)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: 0551-63839536
- Beijing Municipality
  - Beijing, Beijing Municipality, 중국, 130021
    - 모병
    - Beijing Cancer Hospital ( Site 9500)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: (010)88196317
- Fujian
  - Xiamen, Fujian, 중국, 361003
    - 모병
    - The First Affiliated Hospital of Xiamen University ( Site 9503)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: 0592-2139767
- Henan
  - Zhengzhou, Henan, 중국, 450008
    - 모병
    - Henan Cancer Hospital ( Site 9509)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: 0371-65587625
- Jiangsu
  - Xuzhou, Jiangsu, 중국, 221000
    - 모병
    - Xuzhou Central Hospital ( Site 9512)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: 86051680812397
- Jiangxi
  - Nanchang, Jiangxi, 중국, 330006
    - 모병
    - The First Affiliated Hospital of Nanchang University ( Site 9505)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: 86079188692201
체코
- Brno-mesto
  - Brno, Brno-mesto, 체코, 656 53
    - 모병
    - Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 9000)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +420543136812
칠레
- - Antofagasta, 칠레, 1263521
    - 모병
    - Bradford Hill Norte ( Site 1405)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +56442023631
- Los Lagos Region
  - Port Montt, Los Lagos Region, 칠레, 5500243
    - 모병
    - Clínica Puerto Montt ( Site 1406)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +56652484800
- Region M. de Santiago
  - Santiago, Region M. de Santiago, 칠레, 7620002
    - 모병
    - Clínica UC San Carlos de Apoquindo ( Site 1403)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +56223748924
  - Santiago, Region M. de Santiago, 칠레, 8420383
    - 모병
    - Bradfordhill ( Site 1401)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +56220490970
  - Santiago, Region M. de Santiago, 칠레, 7560913
    - 모병
    - Centro de Oncología de Precisión ( Site 1402)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +56972151681
  - Santiago, Region M. de Santiago, 칠레, 7500921
    - 모병
    - Fundación Arturo López Pérez ( Site 1400)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +56224205098
태국
- Bangkok
  - Ratchathewi, Bangkok, 태국, 10400
    - 모병
    - Ramathibodi Hospital ( Site 1103)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +6622004029
- Changwat Songkhla
  - Hat Yai, Changwat Songkhla, 태국, 90110
    - 모병
    - Songklanagarind hospital ( Site 1101)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +6674451469
터키 (Türkiye)
- - Adana, 터키 (Türkiye), 01140
    - 모병
    - Adana Medical Park Seyhan Hastanesi ( Site 9404)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +90444 44 84
  - Ankara, 터키 (Türkiye), 06520
    - 모병
    - Memorial Ankara Hastanesi ( Site 9406)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +905456177189
  - Ankara, 터키 (Türkiye), 06230
    - 모병
    - Hacettepe Universite Hastaneleri ( Site 9401)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +905333319240
  - Ankara, 터키 (Türkiye), 06800
    - 모병
    - Ankara Bilkent Şehir Hastanesi ( Site 9403)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +90 312 552 60 00
  - Erzurum, 터키 (Türkiye), 25070
    - 모병
    - Atatürk Üniversitesi ( Site 9405)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +905543701653
프랑스
- - Paris, 프랑스, 75013
    - 모병
    - Pitie Salpetriere University Hospital ( Site 9102)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +331 42 16 10 41
- Finistere
  - Brest, Finistere, 프랑스, 29609
    - 모병
    - C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 9104)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: 33298223428
- Nord
  - Lille, Nord, 프랑스, 59037
    - 모병
    - CHU Lille - Institut Coeur Poumon ( Site 9100)
    - 연락하다:
      
      Study Coordinator
      
      전화번호: +33320445461

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic squamous cell carcinoma of the esophagus in first-line (1L) setting.
Has measurable disease per RECIST 1.1 as assessed by the local site. investigator or designee/radiology assessment and verified by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
Has had AEs due to previous anticancer therapies that have recovered to ≤Grade 1 or baseline. Endocrine-related AEs that are adequately treated with hormone replacement are elegible.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Has adequate organ function.

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

Has had systemic anticancer therapy for locally advanced unresectable or metastatic esophageal cancer.
Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula.
Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
Has clinically significant corneal disease, history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention.
Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Has inadequate cardiac function assessed as by a corrected QT interval by Fredericia (QTcF) value ≥470 msec.
Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
Has peripheral neuropathy ≥ Grade 2.
Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Has had a history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), has a current diagnosis of ILD, or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out.
Has active infection requiring systemic therapy.
Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
활성 비교기: Pembrolizumab + Chemotherapy Participants will receive 400 mg of pembrolizumab via intravenous (IV) infusion every six weeks (Q6W) on Day 1 of each 42-day cycle up to 18 cycles (up to approximately 2 years), and mFOLFOX6 chemotherapy: oxaliplatin 85 mg/m^2 via IV infusion every 2 weeks (Q2W), until progressive disease (PD) or toxicity; leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 via IV infusion Q2W, until PD or toxicity; 5-fluorouracil (5-FU) 400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity.	의약품: Leucovorin IV infusion 생물학적: Pembrolizumab IV infusion 다른 이름들: MK-3475 키트루다® 의약품: Oxaliplatin IV infusion 의약품: Levoleucovorin IV infusion 의약품: 5-Fluorouracil (5-FU) IV Infusion
실험적: Pembrolizumab + I-DXd Participants will receive 200 mg of pembrolizumab via IV infusion Q3W on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Participants will also receive up to 12 mg/kg I-XDd Q3W via IV infusion, until PD or toxicity.	생물학적: Pembrolizumab IV infusion 다른 이름들: MK-3475 키트루다® 생물학적: I-DXd IV infusion 다른 이름들: DS-7300a MK-2400 이피나타맙 데룩스테칸 의약품: Rescue Medication Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid for Arms 2, 3, and 4, and H1 receptor antagonist, H2 receptor antagonist, acetaminophen, dexamethasone, and steroid mouthwash for Arm 5, administered per approved product label
실험적: Pembrolizumab + I-DXd + 5-FU IV + Leucovorin or Levoleucovorin Participants will receive 200 mg pembrolizumab via IV infusion Q3W on Day 1 of each 21-day cycle up to 35 cycles (up to approximately 2 years). Participants will also receive I-DXd up to 12 mg/kg via IV infusion Q3W, until PD or toxicity; 5-FU 400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, OR 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity; and leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 via IV infusion Q2W, until PD or toxicity.	의약품: Leucovorin IV infusion 생물학적: Pembrolizumab IV infusion 다른 이름들: MK-3475 키트루다® 의약품: Levoleucovorin IV infusion 의약품: 5-Fluorouracil (5-FU) IV Infusion 생물학적: I-DXd IV infusion 다른 이름들: DS-7300a MK-2400 이피나타맙 데룩스테칸 의약품: Rescue Medication Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid for Arms 2, 3, and 4, and H1 receptor antagonist, H2 receptor antagonist, acetaminophen, dexamethasone, and steroid mouthwash for Arm 5, administered per approved product label
실험적: Pembrolizumab + I-DXd + 5-FU IV + Leucovorin or Levoleucovorin + Oxaliplatin Participants will receive 200 mg of pembrolizumab via IV infusion Q3W on Day 1 of each 21-day cycle up to 35 cycles (up to approximately 2 years). Participants will also receive up to 12 mg/kg I-DXd via IV infusion q3w, until PD or toxicity; 5-FU 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity; 60mg/m^2 oxaliplatin via IV infusion Q2W, until PD or toxicity; and leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 via IV infusion Q2W, until PD or toxicity.	의약품: Leucovorin IV infusion 생물학적: Pembrolizumab IV infusion 다른 이름들: MK-3475 키트루다® 의약품: Oxaliplatin IV infusion 의약품: Levoleucovorin IV infusion 의약품: 5-Fluorouracil (5-FU) IV Infusion 생물학적: I-DXd IV infusion 다른 이름들: DS-7300a MK-2400 이피나타맙 데룩스테칸 의약품: Rescue Medication Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid for Arms 2, 3, and 4, and H1 receptor antagonist, H2 receptor antagonist, acetaminophen, dexamethasone, and steroid mouthwash for Arm 5, administered per approved product label
실험적: Pembrolizumab + Sacituzumab tirumotecan + 5-FU IV + Leucovorin or Levoleucovorin Participants will receive 400 mg pembrolizumab via IV infusion Q6W on Day 1 of each 42-day cycle up to 18 cycles (up to approximately 2 years). Participants will also receive sacituzumab tirumotecan 4 mg/kg via IV infusion Days 1, 15, and 29 every 42-day cycle, until PD or toxicity; 5-FU 400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, OR 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity; and leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 via IV infusion Q2W, until PD or toxicity.	의약품: Leucovorin IV infusion 생물학적: Pembrolizumab IV infusion 다른 이름들: MK-3475 키트루다® 의약품: Levoleucovorin IV infusion 의약품: 5-Fluorouracil (5-FU) IV Infusion 의약품: Rescue Medication Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid for Arms 2, 3, and 4, and H1 receptor antagonist, H2 receptor antagonist, acetaminophen, dexamethasone, and steroid mouthwash for Arm 5, administered per approved product label 생물학적: Sacituzumab tirumotecan IV infusion 다른 이름들: SKB264 MK-2870

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase 기간: Up to approximately 28 days	Percentage of participants experiencing toxicities that are possibly, probably, or definitely related to study intervention; that meet pre-defined severity criteria; and result in a change in the given dose.	Up to approximately 28 days
Percentage of Participants who Experience an Adverse Event (AE) 기간: Up to approximately 77 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience an AE will be reported.	Up to approximately 77 months
Objective Response Rate (ORR) 기간: Up to approximately 77 months	ORR is defined as a confirmed complete response (CR: the disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). The percentage of participants who experience CR or PR as assessed by BICR will be presented.	Up to approximately 77 months

2차 결과 측정

결과 측정	측정값 설명	기간
Duration of Response (DOR) 기간: Up to approximately 77 months	For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.	Up to approximately 77 months
Progression-Free Survival (PFS) 기간: Up to approximately 77 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.	Up to approximately 77 months
Overall Survival (OS) 기간: Up to approximately 77 months	OS is defined as the time from allocation/randomization to death due to any cause.	Up to approximately 77 months
Disease Control Rate (DCR) 기간: Up to approximately 77 months	DCR is defined as a confirmed complete response (CR) or partial response (PR), or stable disease (SD) with at least 6 months PFS per RECIST 1.1 as assessed by BICR.	Up to approximately 77 months
Maximum Plasma Concentration (Cmax) of I-DXd 기간: At designated time points up to approximately 65 months	Cmax is defined as the peak level I-DXd reaches in the blood plasma. Blood samples collected predose and at multiple timepoints postdose will be used to determine the Cmax of I-DXd when co-administered with other investigational agents.	At designated time points up to approximately 65 months
Time to Maximum Plasma Concentration (Tmax) of I-DXd 기간: At designated time points up to approximately 65 months	Tmax is defined as the time it took I-DXd to reach its peak level in blood plasma. Blood samples collected predose and at designated timepoints postdose will be used to determine the Tmax of I-DXd when co-administered with other investigational agents.	At designated time points up to approximately 65 months
Area Under the Concentration-Time Curve from Time 0 to Last Measurable Plasma Concentration (AUClast) of I-DXd 기간: At designated time points up to approximately 65 months	AUClast is defined as the area under the concentration-time curve from time 0 to the last measurable concentration of I-DXd in the blood plasma. Blood samples collected at predose and at designated timepoints postdose will be used to determine the AUClast of I-DXd in combination with other agents.	At designated time points up to approximately 65 months
Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Period (AUCtau) of I-DXd 기간: At designated time points up to approximately 65 months	AUCtau is defined as the area under the concentration-time curve from time zero to the end of the dosing period. Blood samples collected at predose and at designated timepoints postdose will be used to determine the AUCtau of I-DXd in combination with other agents.	At designated time points up to approximately 65 months
The Percentage of Participants with Antidrug Antibodies (ADA) Against I-DXd 기간: Up to approximately 65 months	Blood samples collected at designated timepoints will be used to determine the ADA response to I-DXd. The percentage of participants with ADA will be reported.	Up to approximately 65 months
The Percentage of Participants with Treatment-Emergent ADA Against I-DXd 기간: Up to approximately 65 months	Blood samples collected at designated timepoints will be used to determine the treatment-emergent ADA response to I-DXd. The percentage of participants who have treatment-emergent I-DXd ADA will be reported.	Up to approximately 65 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Merck Sharp & Dohme LLC

협력자

Daiichi Sankyo

수사관

연구 책임자: Medical Director, Merck Sharp & Dohme LLC

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 7월 30일

기본 완료 (추정된)

2032년 1월 4일

연구 완료 (추정된)

2032년 1월 4일

연구 등록 날짜

최초 제출

2025년 1월 13일

QC 기준을 충족하는 최초 제출

2025년 1월 13일

처음 게시됨 (실제)

2025년 1월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 23일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

3475-06E
MK-3475-06E (기타 식별자: MSD)
U1111-1307-6484 (레지스트리 식별자: UTN)
jRCT2041240166 (레지스트리 식별자: Japan Registry of Clinical Trials (jRCT))
2024-514273-22-00 (레지스트리 식별자: EU CT)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

하위 연구 06E: 식도암의 병용 요법에 대한 우산 연구(MK-3475-06E/KEYMAKER-U06)

1L 국소 진행성 절제 불가능/전이성 식도암 참가자를 대상으로 화학요법 유무에 관계없이 Pembrolizumab(MK-3475)과 결합된 조사 약물에 대한 1/2상 오픈 라벨, 엄브렐라 플랫폼 설계 연구: KEYMAKER-U06 하위 연구 06E

연구 개요

상태

정황

개입 / 치료

상세 설명

연구 유형

등록 (추정된)

단계

연락처 및 위치

연구 연락처

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

팔의 수

무기와 개입

참가자 그룹 / 팔

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

협력자

수사관

간행물 및 유용한 링크

유용한 링크

연구 기록 날짜

연구 주요 날짜

연구 시작 (실제)

기본 완료 (추정된)

연구 완료 (추정된)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구